How to get your medical equipment listed?
How to get your veterinary equipment listed?
First thing to do is to understand what your equipment does or better yet, tell us what it does so we can help you pick the standard. Once you know what standard you need to use, then designing your equipment for the standard or making small tweaks to make it mee the standard is much easier.
Lists of Standard Number IEC 60601 is the base standard number for medical equipment
For North America check for your standard here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm
IEC 60601-1:2020 SER Medical electrical equipment. This standard covers electrical requirements for medical equipment and specifically grounding and any touch currents that might be encountered while operating the equipment. Specifically look for details. For equipment that comes in contact with the patient.
IEC 60601-1-2:2014+AMD1:2020     Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests, this section will have the detailed performance requirements and limits for radiofrequency emissions and noise omissions onto the mains. These are required to be sure that the equipment doesn’t interfere with other medical equipment in the area, thereby causing a problem for the facility or more importantly for the patient.
IEC 60601-1-3:2008+AMD1:2013 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment, this standard is in addition to the seedier eight standards in the US. The standard deals with protecting patients and operators from collateral x-ray emissions.
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. This standard is critical that it details how to make the equipment easy to use and understand for the operators. It also standardizes on and off buttons, alarms and other functions so that operators can easily and more effectively operate the equipment safely.
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. This standard deals with the alarms and alarm systems within equipment giving details on the parameters of those alarms and functionality and reliability for those alarm systems.
IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
IEC 60601-1-11:2015+AMD1:2020 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, this standard deals with systems that are more for use in the home as opposed to the hospital and how they became made safe for this application.
IEC 60601-1-12:2014+AMD1:2020 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment, this standard is for equipment that is more portable and therefore must be more rugged and robust in nature, then permanently mounted equipment in the hospital.
You need a safe and clear path to approvals for conformity on the safety side as the medical and efficacy requirements are also taking your attention. We use our conformity Discovery process to get you there faster and easier. After having done numerous medical equipment projects. We are fully vetted incapable of helping you deliver your product to market How we help you comply and get certified, is by using a tried and tested process to get you there.
All medical equipment, any machine used in a doctor’s office, hospital or in-home healthcare.
Medical offices, surgery suites, patient rooms, nurses’ stations, home healthcare, medical testing equipment, medical diagnostic equipment, x-ray equipment, laser medical equipment, aesthetic equipment, cosmetology equipment, and all other equipment that performs a medical health benefit for the patient or client.
| Standard Designation Number/Date | Title of Standard | Specialty Task Group | Standard Developing Organization |
| H30-A2 | Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition | InVitro Diagnostics | CLSI |
| H56-A (Replaces H56-P) | Body Fluid Analysis for Cellular Composition; Approved Guideline. | InVitro Diagnostics | CLSI |
| AUTO5-A | Laboratory Automation: Electromechanical Interfaces; Approved Standard | Software/Informatics | CLSI |
| 60601-2-31 Edition 2.1 2011-09 | Medical electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | Cardiovascular | IEC |
| F1874-98 (Reapproved 2011) | Standard Test Method for Bend Testing of Needles Used in Surgical Sutures | General Plastic Surgery/General Hospital | ASTM |
| GP20-A2 (Replaces GP20-A) | Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| EP17-A2 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| 9917-2 Second edition 2010-04-15 | Dentistry – Water-based cements – Part 2: Resin-modified cements | Dental/ENT | ISO |
| 10555-3 Second edition 2013-06-15 | Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters | General Plastic Surgery/General Hospital | ISO |
| D6355-07 (Reapproved 2017) | Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| G5-14 | Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements | Materials | ASTM |
| TR 80001-2-5 Edition 1.0 2014-12 | Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems | Software/Informatics | IEC |
| 7197 Third edition 2006-06-01 | Neurosurgical Implants – Sterile single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] | Neurology | ISO |
| Std 11073-10425-2014 | Health informatics – Personal health device communication Part 10425: Device Specialization – Continuous Glucose Monitor (CGM) | Software/Informatics | IEEE |
| Specification No. 57 (Reaffirmed 2012) | Endodontic Sealing Material | Dental/ENT | ANSI ADA |
| 12417 First edition 2015-10-01 | Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products | Cardiovascular | ISO |
| Specification No. 78:2006 | Dental obturating cones (Modified adoption of ISO 6877-1:1995 Dental obturating points) | Dental/ENT | ANSI ADA |
| Z1.4-2003 (R2018) | Sampling Procedures and Tables for Inspection by Attributes | General I (QS/RM) | ANSI ASQ |
| F619-14 | Standard Practice for Extraction of Medical Plastics | Biocompatibility | ASTM |
| MS-1-2008 (R2014) | Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging | Radiology | NEMA |
| 62485-4 Edition 1.0 2015-01 | Safety requirements for secondary batteries and battery installations – Part 4: Valve-regulated lead-acid batteries for use in portable appliances | General II (ES/EMC) | IEC |
| \TS 10974 Second edition 2018 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device | Materials | ISO |
| 11137-3 Second edition 2017-06 | Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development validation and routine control | Sterility | ISO |
| F2026-17 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications | Materials | ASTM |
| /TR 37137 First edition 2014-05-15 | Cardiovascular biological evaluation of medical devices – Guidance for absorbable implants | Biocompatibility | ISO |
| 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION | Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields | Radiology | IEC |
| 5841-3 Third edition 2013-04-15 | Implants for surgery – Cardiac pacemakers – Part 3: Low-profile connectors [IS-I] for implantable pacemakers | Cardiovascular | ISO |
| 60601-2-44 Edition 3.2: 2016 | Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography | Radiology | IEC |
| F1160-14 (Reapproved 2017)e1 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings | Materials | ASTM |
| E667-98 (Reapproved 2017) | Standard Specification for Mercury-in-Glass Maximum Self-Registering Clinical Thermometers | General Plastic Surgery/General Hospital | ASTM |
| D903-98 (Reapproved 2017) | Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds | General I (QS/RM) | ASTM |
| 15026-1 First edition 2013-11-01 | Systems and software engineering – Systems and software assurance – Part 1: Concepts and vocabulary | Software/Informatics | IEC ISO |
| F562-13 | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) | Materials | ASTM |
| WC-1:2009 Section 8 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and Test Methods for Static Impact and Fatigue Strengths | Physical Medicine | ANSI RESNA |
| F2977-13 | Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants | Materials | ASTM |
| F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Sterility | ASTM |
| F799-19 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537 R31538 R31539) | Materials | ASTM |
| 42-NF37:2019 | <87> Biological Reactivity Test In Vitro – Elution Test | Biocompatibility | USP |
| /TS 20914 First edition 2019-07 | Medical laboratories – Practical guidance for the estimation of measurement uncertainty | InVitro Diagnostics | ISO |
| F3087-15 | Standard Specification for Acrylic Molding Resins for Medical Implant Applications | Materials | ASTM |
| F3047M-15 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations | Orthopedic | ASTM |
| 7206-10 Second edition 2018-08 | Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads | Orthopedic | ISO |
| 5834-4 Second edition 2019-02 | Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 4: Oxidation index measurement method | Materials | ISO |
| F2385-15 (Reapproved 2019) | Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs | Orthopedic | ASTM |
| F1264-16 | Standard Specification and Test Methods for Intramedullary Fixation Devices | Orthopedic | ASTM |
| TIR66: 2017/(R)2020 | Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms | General I (QS/RM) | AAMI |
| WC-1:2009 Section 1 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability | Physical Medicine | ANSI RESNA |
| 14644-1 Second edition 2015-12-15 | Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration | Sterility | ISO |
| F2979-14 | Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses | Orthopedic | ASTM |
| /TS 21362 First edition 2018-06 | Nanotechnologies – Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation | Nanotechnology | ISO |
| WC-1:2019 Section 1 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability | Physical Medicine | ANSI RESNA |
| 10993-2 Second edition 2006-07-15 | Biological Evaluation of medical devices – Part 2: Animal welfare requirements | Biocompatibility | ISO |
| E2859-11 (Reapproved 2017) | Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy | Nanotechnology | ASTM |
| WC-1:2019 Section 8 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static Iipact and fatigue strengths | Physical Medicine | ANSI RESNA |
| 7010 Third edition 2019-07 | Graphical symbols – Safety colours and safety signs – Registered safety signs | General I (QS/RM) | ISO |
| F1717-18 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | Orthopedic | ASTM |
| D3078-02 (Reapproved 2013) | Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission | Sterility | ASTM |
| C63.19-2011 | American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids | Dental/ENT | ANSI IEEE |
| C63.18-2014 | American National Standard Recommended Practice for an On-Site Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters | General II (ES/EMC) | ANSI IEEE |
| F2721-09 (Reapproved 2014) | Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects | Tissue Engineering | ASTM |
| 15459-2 Third edition 2015-03-01 | Information technology – Automatic identification and data capture techniques – Unique identification – Part 2: Registration procedures | Software/Informatics | IEC ISO |
| F1537-11 | Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537 UNS R31538 and UNS R31539) | Materials | ASTM |
| 5832-5 Third edition 2005-10-15 | Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel alloy | Materials | ISO |
| GP23-A2 (Replaces GP23-A) | Nongynecological Cytology Specimens: Preexamination Examination and Postexamination Processes; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| 18835 First Edition 2015-04-01 | Inhalational Anaesthesia Systems – Draw-over Anaesthetic Systems | Anesthesiology | ISO |
| 22442-1 Second edition 2015-11-01 | Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management | Tissue Engineering | ISO |
| 8536-6 Third edition 2016-12-01 | Infusion equipment for medical use – Part 6:Â Freeze drying closures for infusion bottles | General Plastic Surgery/General Hospital | ISO |
| 22442-2 Second edition 2015-11-01 | Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing collection and handling. | Tissue Engineering | ISO |
| 80001-1 Edition 1.0 2010-10 | Application of risk management for IT-networks incorporating medical devices – Part 1: Roles responsibilities and activities | Software/Informatics | IEC |
| F2212-11 | Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPS) | Tissue Engineering | ASTM |
| 52902:First Edition 2019-07 | Additive Manufacturing -Test Artifacts – Geometric capability assessment of additive manufacturing systems | Materials | ASTM ISO |
| F2150-13 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissued-Engineered Medical Products | Tissue Engineering | ASTM |
| E2578-07 (Reapproved 2018) | Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions | Nanotechnology | ASTM |
| 61010-1 Edition 3.1 2017-01 | Safety requirements for electrical equipment for measurement control and laboratory use – Part 1: General requirements | General II (ES/EMC) | IEC |
| F3334-19 | Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components | Orthopedic | ASTM |
| D5250-06 (Reapproved 2015) | Standard Specification for Poly(vinyl chloride) Gloves for Medical Application | General Plastic Surgery/General Hospital | ASTM |
| F2475-20 | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials | Sterility | ASTM |
| 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software – Software life cycle processes | Software/Informatics | IEC |
| 81060-2 Third edition 2018-11 | Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type | Cardiovascular | ISO |
| 52628 Second edition 2020-04 | Standard practice for dosimetry in radiation processing | Sterility | ASTM ISO |
| 51276 Second edition 2012-07-15 | Practice for use of a polymethylmethacrylate dosimetry system | Sterility | ASTM ISO |
| 11073-10101 First edition 2004-12-15 | Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature | Software/Informatics | IEEE ISO |
| F2579-18 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants | Materials | ASTM |
| MM17 2nd Edition | Verification and Validation of Multiplex Nucleic Acid Assays | InVitro Diagnostics | CLSI |
| 61223-3-5 First edition 2004-08 | Evaluation and routine testing in medical imaging departments – Part 3-5: Acceptance tests – Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] | Radiology | IEC |
| 14801 Third edition 2016-11-01 | Dentistry – Implants – Dynamic loading test for endosseous dental implants | Dental/ENT | ISO |
| 80601-2-60 Edition 2.0 2019-06 | Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment | Dental/ENT | IEC |
| F1841-19 | Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps | Cardiovascular | ASTM |
| 11073-90101 First edition 2008-01-15 | Health informatics – Point-of-care medical device communication – Part 90101: Analytical instruments — Point-of-care test | Software/Informatics | ISO |
| 11664-1:2019 | Colorimetry – Part 1: CIE standard colorimetric observers | ObGyn/Gastroenterology/Urology | CIE ISO |
| 61223-2-6 Second Edition 2006-11 | Evaluation and routine testing in medical imaging departments – Part 2-6: Constancy tests – Imaging performance of computed tomography X-ray equipment | Radiology | IEC |
| 81060-2 Third edition 2018-11 | Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type [including: Amendment 1 (2020)] | Cardiovascular | ISO |
| F997-18 | Standard Specification for Polycarbonate Resin for Medical Applications | Materials | ASTM |
| F1088-04a (Reapproved 2010) | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation | Materials | ASTM |
| 6474-1 First edition 2010-02-15 | Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina | Materials | ISO |
| WC-4:2017 Section 19 | American National Standard for Wheelchairs – Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles. | Physical Medicine | ANSI RESNA |
| TIR97:2019 | Principles for medical device security – Postmarket risk management for device manufacturers | Software/Informatics | AAMI |
| UD 2-2004 (R2009) | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 | Radiology | NEMA |
| 5832-9 Second edition 2007-06-15 | Implants for surgery – Metallic materials – Part 9:Â Wrought high nitrogen stainless steel | Materials | ISO |
| 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 | Colorimetry – Part 2: CIE standard illuminants | ObGyn/Gastroenterology/Urology | CIE ISO |
| 5834-5 Second edition 2019-02 | Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 5: Morphology assessment method | Materials | ISO |
| 14971 Second edition 2007-03-01 | Medical devices – Application of risk management to medical devices | General I (QS/RM) | ISO |
| D7103-19 | Standard Guide for Assessment of Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| /TS 21726 First edition 2019-02 | Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents | Biocompatibility | ISO |
| F2888-19 | Standard Practice for Platelet Leukocyte Count – An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. | Biocompatibility | ASTM |
| 3E 2017 | Similar Packaged-Products in Unitized Loads of Truckload Shipment | General I (QS/RM) | ISTA |
| 5910 First edition 2018-06 | Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices | Cardiovascular | ISO |
| F2182-11a | Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging | Materials | ASTM |
| 10993-9 Second edition 2009-12-15 | Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products | Biocompatibility | ISO |
| Standard No. 19 – 2018 | Elastometric Impression Materials | Dental/ENT | ANSI ADA |
| WC-4:2017 Section 18 | American National Standard for Wheelchairs – Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. | Physical Medicine | RESNA |
| WC-4:2017 Section 20 | American National Standard for Wheelchairs – Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles | Physical Medicine | ANSI RESNA |
| 7494-1 Third edition 2018-06 | Dentistry – Stationary dental units and dental patient chairs – Part 1: General requirements | Dental/ENT | ISO |
| EC57:2012 | Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms | Cardiovascular | ANSI AAMI |
| 60601-2-18: Edition 3.0 2009-08 | Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | ObGyn/Gastroenterology/Urology | IEC |
| 60601-2-52 Edition 1.0 2009-12 | Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] | General Plastic Surgery/General Hospital | IEC |
| /TS 17200 First edition 2013-06-01 | Nanotechnology – Nanoparticles in powder form – Characteristics and measurements | Nanotechnology | ISO |
| Z80.12-2007 (R2017) | American National Standard for Ophthalmics – Multifocal Intraocular Lenses | Ophthalmic | ANSI |
| BP22:1994 (R2016) | Blood pressure transducers | Cardiovascular | ANSI AAMI |
| 17327-1 First edition 2018-02 | Non-active surgical implants – Implant coating – Part 1: General requirements | Materials | ISO |
| WC-1:2019 Section 20 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs | Physical Medicine | ANSI RESNA |
| WC-2:2019 Section 21 | American National Standard for Wheelchairs – Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters | Physical Medicine | ANSI RESNA |
| WC-2:2019 Section 4 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range | Physical Medicine | ANSI RESNA |
| WC-1:2019 Section 5 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions mass and maneuvering space | Physical Medicine | ANSI RESNA |
| WC-2:2019 Section 14 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods | Physical Medicine | ANSI RESNA |
| Standards Publication XS 14-2019 | Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems | Radiology | NEMA |
| 13695:2004 | Optics and photonics – Lasers and laser-related equipment – Test methods for the spectral characteristics of lasers | Radiology | ISO |
| PS 3.1 – 3.20 (2016) | Digital Imaging and Communications in Medicine (DICOM) Set | Radiology | NEMA |
| 61303 Edition 1.0 1994-09 | Medical electrical equipment – Radionuclide calibrators – Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] | Radiology | IEC |
| F1841-97 (Reapproved 2017) | Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps egg | Cardiovascular | ASTM |
| 60601-2-47 Edition 2.0 2012-02 | Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems | Cardiovascular | IEC |
| 80601-2-30 Edition 1.1 2013-07 | Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers | Cardiovascular | IEC |
| MS 6-2008 (R2014) | Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging | Radiology | NEMA |
| 594-1 First edition 1986-06-15 | Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment – Part 1: General requirements | General Plastic Surgery/General Hospital | ISO |
| 62220-1-3 Edition 1.0 2008-06 | Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-3: Determination of the detective quantum efficiency – Detectors used in dynamic imaging | Radiology | IEC |
| 11664-4 First edition 2019-06 | Colorimetry – Part 4: CIE 1976 L*a*b* colour space | ObGyn/Gastroenterology/Urology | CIE ISO |
| F1088-18 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation | Materials | ASTM |
| F1830-19 | Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps | Cardiovascular | ASTM |
| Std 11073-10421-2010 | Health informatics – Personal health device communication Part 10421: Device specialization – Peak expiratory flow monitor (peak flow) | Software/Informatics | IEEE |
| Std 11073-10406-2011 | Health informatics – Personal health device communication Part 10406: Device specialization – Basic electrocardiograph | Software/Informatics | IEEE |
| 11073-10418 First edition 2014-03-01 | Health informatics – Personal health device communication – Part 10418: Device specialization – International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] | Software/Informatics | IEEE ISO |
| 5834-1 Fourth edition 2019-02 | Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 1: Powder form | Materials | ISO |
| 60825-1 Edition 2.0 2007-03 | Safety of laser products – Part 1:Â Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)] | Radiology | IEC |
| 61161 Edition 3.0 2013-01 | Ultrasonics — Power measurement — Radiation force balances and performance requirements | Radiology | IEC |
| XR 23-2006 | Quality Control Manual Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography | Radiology | NEMA |
| 62220-1-2 Edition 1.0 2007-06 | Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-2: Determination of the detective quantum efficiency – Detectors used in mammography | Radiology | IEC |
| 594-2 Second edition 1998-09-01 | Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment – Part 2: Lock fittings | General Plastic Surgery/General Hospital | ISO |
| F688-14 | Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate Sheet and Foil for Surgical Implants (UNS R30035) | Materials | ASTM |
| 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | Radiology | IEC |
| NU 2-2018 | Performance Measurements of Positron Emission Tomographs | Radiology | NEMA |
| 3A 2018 | Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less | General I (QS/RM) | ISTA |
| 80601-2-77 Edition 1.0 2019-07 | Medical electrical equipment – Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT | General Plastic Surgery/General Hospital | IEC |
| F2182-19e2 | Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance | Materials | ASTM |
| 15142-2 First edition 2003-08-01 | Implants for surgery – Metal intramedullary nailing systems – Part 2: Locking components | Orthopedic | ISO |
| F2579-10 | Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants | Materials | ASTM |
| M62 1st Edition | Performance Standards for Susceptibility Testing of Mycobacteria Nocardia spp. and other Aerobic Actinomycetes | InVitro Diagnostics | CLSI |
| /TR 11360 First edition 2010-07-15 | Nanotechnologies – Methodology for the classification and categorization of nanomaterials | Nanotechnology | ISO |
| F561-19 | Standard Practice for Retrieval and Analysis of Medical Devices and Associated Tissues and Fluids | Materials | ASTM |
| 11664-3 First edition 2019-06 | Colorimetry – Part 3: CIE tristimulus values | ObGyn/Gastroenterology/Urology | CIE ISO |
| F2633-19 | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants | Materials | ASTM |
| F2475-11 | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials | Sterility | ASTM |
| F2633-13 | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants | Materials | ASTM |
| F2315-18 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels | Tissue Engineering | ASTM |
| F2103-18 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications | Tissue Engineering | ASTM |
| 3A 2008 | Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less | General I (QS/RM) | ISTA |
| 3B 2017 | Packaged-Products for Less-Than-Truckload (LTL) Shipment | General I (QS/RM) | ISTA |
| 3B 2012 | Packaged-Products for Less-Than-Truckload (LTL) Shipment | General I (QS/RM) | ISTA |
| 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures | Radiology | IEC |
| 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures | Radiology | IEC |
| S3.36-2012 (Reaffirmed 2018) | American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements | Dental/ENT | ANSI ASA |
| 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | Radiology | IEC |
| F3036-13 | Standard Guide for Testing Absorbable Stents | Cardiovascular | ASTM |
| 7176 – 30 First edition 2018-12 | Wheelchairs –Part 30: Wheelchairs for changing occupant posture –Test methods and requirements | Physical Medicine | ISO |
| 18192-3 First edition 2017-06 | Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions | Orthopedic | ISO |
| 5834-2 Fifth edition 2019-02 | Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 2: Moulded forms | Materials | ISO |
| 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION | Medical devices – Part 1: Application of usability engineering to medical devices | General I (QS/RM) | IEC |
| 10993-17 First edition 2002-12-01 | Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances | Biocompatibility | ISO |
| 42-NF37:2019 | <88> Biological Reactivity Tests In Vivo | Biocompatibility | USP |
| 42-NF37:2019 | <151> Pyrogen Test (USP Rabbit Test) | Biocompatibility | USP |
| 18369-2 Third edition 2017-08 | Ophthalmic optics – Contact lenses – Part 2: Tolerances | Ophthalmic | ISO |
| Z80.28-2017 | American National Standard for Ophthalmics – Methods of Reporting Optical Aberrations of Eyes | Ophthalmic | ANSI |
| Z80.29-2015 | American National Standard for Ophthalmics – Accomodative Intraocular Lenses | Ophthalmic | ANSI |
| Std 11073-10207-2017 | Health informatics – Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication | Software/Informatics | IEEE |
| RP-27.2-00/R17 | Recommended Practice for Photobiological Safety for Lamps and Lamp Systems – Measurement Techniques | Radiology | ANSI IES |
| RP-27.3-17 | Recommended Practice for Photobiological Safety for Lamps – Risk Group Classification and Labeling | Radiology | ANSI IES |
| 80601-2-69 First edition 2014-07-15 | Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment | Anesthesiology | ISO |
| 19223 First edition 2019-07 | Lung ventilators and related equipment – Vocabulary and semantics. | Anesthesiology | ISO |
| 60731 Edition 3.1 2016-04 | Consolidated Version Medical electrical equipment – Dosimeters with ionization chambers as used in radiotherapy | Radiology | IEC |
| LIS03-A | Standard Guide for Selection of a Clinical Laboratory Information Management System | Software/Informatics | CLSI |
| 5832-9 Third edition 2019-02 | Implants for surgery – Metallic materials – Part 9:Â Wrought high nitrogen stainless steel | Materials | ISO |
| 6474-1 Second edition 2019-03 | Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina | Materials | ISO |
| F75-18 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) | Materials | ASTM |
| F1580-18 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants | Materials | ASTM |
| 5832-12 Third edition 2019-02 | Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum alloy | Materials | ISO |
| F2101-19 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials Using a Biological Aerosol of Staphylococcus aureus | General Plastic Surgery/General Hospital | ASTM |
| F2038-18 | Standard Guide for Silicone Elastomers Gels and Foams Used in Medical Applications Part I – Formulations and Uncured Materials | Materials | ASTM |
| F2516-18 | Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials | Materials | ASTM |
| 8600-3 Second edition 2019-08 | Endoscopes – Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. | ObGyn/Gastroenterology/Urology | ISO |
| 80601-2-13 First edition 2011-08-11 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] | Anesthesiology | ISO |
| /TR 10993-33 First Edition 2015-03-01 | Biological evaluation of medical devices – Part 33: Guidance on tests to evaluate genotoxicity – Supplement to ISO 10993-3 | Biocompatibility | ISO |
| S3.4-2007 (Reaffirmed 2017) | American National Standard Procedure for the Computation of Loudness of Steady Sounds | Dental/ENT | ANSI |
| 3E 2009 | Unitized Loads of Same Product | General I (QS/RM) | ISTA |
| 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] | Dentistry – Ceramic materials | Dental/ENT | ISO |
| 10650 Second edition 2018-08 | Dentistry – Powered polymerization activators | Dental/ENT | ISO |
| Standard No. 27-2016 | Polymer-based Restorative Materials | Dental/ENT | ANSI ADA |
| Standard No. 99 – 2001 (Reaffirmed 2013) | Athletic Mouth Protectors and Materials | Dental/ENT | ANSI ADA |
| Standard No. 132 – 2015 | Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems | Dental/ENT | ANSI ADA |
| QMS01 5th ed. June 2019 (Replaces QMS01-A4) | A Quality Management System Model for Laboratory Services. | InVitro Diagnostics | CLSI |
| M100 29th ed. January 2019 (Replaces M100 28th ed). | Performance Standards for Antimicrobial Susceptibility Testing | InVitro Diagnostics | CLSI |
| 10993-9Â Third edition 2019-11 | Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products | Biocompatibility | ISO |
| 13779-4 Second edition 2018-12 | Implants for surgery – Hydroxyapatite – Part 4: Determination of coating adhesion strength | Materials | ISO |
| 60601-2-6 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment | General Plastic Surgery/General Hospital | IEC |
| /TS 18827 First edition 2017-06 | Nanotechnologies – Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials | Nanotechnology | ISO |
| WC-2:2019 Section 9 | American National Standard for Wheelchairs –Â Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs | Physical Medicine | ANSI RESNA |
| WC-1:2019 Section 11 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins | Physical Medicine | ANSI RESNA |
| 10993-7 Second edition 2008-10-15 | Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)Â AMENDMENT 1: Applicability of allowable limits for neonates and infants (2020)] | Biocompatibility | ISO |
| 10993-7 Second edition 2008-10-15 | Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)] | Biocompatibility | ISO |
| 11073-10421 First edition 2012-11-01 | Health informatics – Personal health device communication – Part 10421: Device specialization – Peak expiratory flow monitor (peak flow) | Software/Informatics | IEEE ISO |
| 11073-10424 First edition 2016-06-15 | Health informatics – Personal health device communication – Part 10424: Device specialization – Sleep Apnoea Breathing Therapy Equipment (SABTE) | Software/Informatics | IEEE ISO |
| F2503-13 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | Materials | ASTM |
| Std 11073-10101-2019 | Health informatics – Point-of-care medical device communication. Part 10101: Nomenclature | Software/Informatics | IEEE |
| 11073-20702 First edition 2018-09 | Health informatics – Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services | Software/Informatics | ISO |
| Std 11073-20701-2018 | Health informatics – Point-of-care medical device communication – Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding | Software/Informatics | IEEE |
| 8536-4 Fifth edition 2010-10-01 | Infusion equipment for medical use – Part 4: Infusion sets for single use gravity feed [Including: Amendment 1 (2013)] | General Plastic Surgery/General Hospital | ISO |
| F2503-20 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | Materials | ASTM |
| D6124-06 (Reapproved 2017) | Standard Test Method for Residual Powder on Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| TIR 42:2010 | Evaluation of Particulates Associated with Vascular Medical Devices | Cardiovascular | AAMI |
| EP27-A | How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays 1st Edition | InVitro Diagnostics | CLSI |
| F2901-19 | Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices | Biocompatibility | ASTM |
| 60601-2-16 Edition 5.0 2018-4 | Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis haemodiafiltration and haemonfiltration equipment | ObGyn/Gastroenterology/Urology | IEC |
| 7000 Sixth edition 2019-07 | Graphical symbols for use on equipment – Registered symbols | General I (QS/RM) | ISO |
| 2800-1: 2019 | (American National Standard) Standard for Safety for Medical Device Interoperability | Software/Informatics | AAMI ANSI UL |
| 23907-1 First edition 2019-01 | Sharps injury protection – Requirements and test methods – Sharps containers | General Plastic Surgery/General Hospital | ISO |
| 23907 First edition 2012-09-01 | Sharps injury protection – Requirements and test methods – Sharps containers | General Plastic Surgery/General Hospital | ISO |
| 23907-2 First edition 2019-11 | Sharps injury protection – Requirements and test methods – Part 2: Reusable sharps containers. | General Plastic Surgery/General Hospital | ISO |
| F1830-97 (Reapproved 2017) | Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps | Cardiovascular | ASTM |
| 80601-2-74 First edition 2017-05 | Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment | Anesthesiology | ISO |
| /TS 19930 First edition 2017-12 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 | Sterility | ISO |
| 11664-6 First edition 2014-02-01 | Colorimetry – Part 6: CIEDE2000 colour-difference formula | ObGyn/Gastroenterology/Urology | CIE ISO |
| 61966-2-1 First edition 1999-10 | Multimedia systems and equipment – Colour measurement and management – Part 2-1: Colour management – Default RGB colour space – sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)] | ObGyn/Gastroenterology/Urology | CIE ISO |
| 60601-2-1 Edition 3.1 2014-07 | Medical electrical equipment – Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV | Radiology | IEC |
| 61223-3-5 Edition 2.0 2019-09 | Evaluation and routine testing in medical imaging departments – Part 3-5: Acceptance tests – Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] | Radiology | IEC |
| F2100-19 | Standard Specification for Performance of Materials Used in Medical Face Masks | General Plastic Surgery/General Hospital | ASTM |
| 42-NF37:2019 | <881> Tensile Strength | General Plastic Surgery/General Hospital | USP |
| F1378-18e1 | Standard Specification for Shoulder Prostheses | Orthopedic | ASTM |
| 11990 Third edition 2018-08 | Lasers and laser-related equipment – Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs | Radiology | ISO |
| 13694 Third edition 2018-11 | Optics and Photonics – Lasers and laser-related equipment – Test methods for laser beam power (energy) density distribution | Radiology | ISO |
| F2063-18 | Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants | Materials | ASTM |
| F1314-18 | Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) | Materials | ASTM |
| F2066-18 | Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) | Materials | ASTM |
| HA60601-1-11:2015 | Medical Electrical Equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) | General II (ES/EMC) | ANSI AAMI |
| 62127-1 Edition 1.1 2013-02 | Ultrasonics — Hydrophones — Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz | Radiology | IEC |
| 62555 Edition 1.0 2013-11 | Ultrasonics — Power measurement — High intensity therapeutic ultrasound (HITU) transducers and systems | Radiology | IEC |
| 12609-2 First edition 2013-07-15 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use | Radiology | ISO |
| 60601-2-62 Edition 1.0 2013-07 | Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment | Radiology | IEC |
| 61910-1 Edition 1.0 2014-09 | Medical electrical equipment – Radiation dose documentation – Part 1: Radiation dose structured reports for radiography and radioscopy | Radiology | IEC |
| F702-18 | Standard Specification for Polysulfone Resin for Medical Applications | Materials | ASTM |
| 18242 First edition 2016-09-01 | Cardiovascular implants and extracorporeal systems – Centrifugal blood pumps. | Cardiovascular | ISO |
| 10139-2 Third edition 2016-06-15 | Dentistry – Soft lining materials for removable dentures – Part 2: Materials for long-term use | Dental/ENT | ISO |
| 5834-1 Third edition 2005-06-01 | Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 1: Powder form [Including: Technical Corrigendum 1 (2007)] | Materials | ISO |
| 62464-1 Edition 2.0 2018-12 | Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. | Radiology | IEC |
| RT3:2020 | Radiation therapy machine characterization | Radiology | AAMI |
| Standards Publication XR 25 -2019 | Computed Tomography Dose Check | Radiology | NEMA |
| XR 25 | Computed Tomography Dose Check | Radiology | NEMA |
| F2602-18 | Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) | Tissue Engineering | ASTM |
| 9693 Third edition 2019-10 | Dentistry – Compatibility testing for metal-ceramic and ceramic-ceramic systems | Dental/ENT | ISO |
| F897-02 (Reapproved 2013) | Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws | Orthopedic | ASTM |
| 5360 Fourth edition 2016-02-15 | Anaesthetic vaporizers – Agent specific filling systems | Anesthesiology | ISO |
| BE83:2006/(R)2011 | Biological evaluation of medical devices – Part 18: Chemical characterization of materials | Biocompatibility | ANSI AAMI |
| Z80.20-2016 | American National Standard for Ophthalmics – Contact Lenses – Standard Terminology Tolerances Measurements and Physicochemical Properties | Ophthalmic | ANSI |
| 5364 Fifth edition 2016-09-01 | Anaesthetic and respiratory equipment-Oropharyngeal airways | Anesthesiology | ISO |
| F2148-18 | Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). | Biocompatibility | ASTM |
| F2382-18 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | Biocompatibility | ASTM |
| 14242-1 Third edition 2014-10-15 | Implants for surgery – Wear of total hip-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] | Orthopedic | ISO |
| 6474-2 First edition 2012-04-15 | Implants for surgery – Ceramic materials – Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement | Materials | ISO |
| 7405 Third edition 2018-10 Corrected version 2018-12 | Dentistry – Evaluation of biocompatibility of medical devices used in dentistry | Dental/ENT | ISO |
| 7405 Second edition 2008-12-15 | Dentistry – Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)] | Dental/ENT | ISO |
| F2042-18 | Standard Guide for Silicone Elastomers Gels and Foams Used in Medical Applications – Part II – Crosslinking and Fabrication | Materials | ASTM |
| WC-4:2017 Section 10 | American National Standard for Wheelchairs – Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers. | Physical Medicine | ANSI RESNA |
| /TS 81060-5 First edition 2020-02 | Non-invasive sphygmomanometers – Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers | Cardiovascular | ISO |
| 62127-2 Edition 1.1 2013-02 | Ultrasonics — Hydrophones — Part 2: Calibration for ultrasonic fields up to 40 MHz | Radiology | IEC |
| 13779-2 Third edition 2018-12 | Implants for surgery – Hydroxyapatite – Part 2: Thermally sprayed coatings of hydroxyapatite | Materials | ISO |
| F75-12 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) | Materials | ASTM |
| F1580-12 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants | Materials | ASTM |
| 80601-2-60 Edition 1.0 2012-02 | Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment | Dental/ENT | IEC |
| 14117 First edition 2012-07-15 | Active implantable medical devices — Electromagnetic compatibility — EMC test protocols For implantable cardiac pacemakers implantable cardioverter defibrillators and cardiac resynchronization devices | Cardiovascular | ISO |
| QMS01-A4 (Replaces GP26 and HS01-A2) | Quality Management System: A Model for Laboratory Services; Approved Guideline-Fourth Edition | InVitro Diagnostics | CLSI |
| M100 29th ed. January 2019 (Replaces M100 28th ed). | Performance Standards for Antimicrobial Susceptibility Testing | InVitro Diagnostics | CLSI |
| 8600-3 First edition 1997-07-01 (Amendment 1 2003-12-01 | Optics and Optical instruments – Medical endoscopes and endoscopic accessories – Part 3: Determination of field of view and direction of view of endoscopes with optics [Including: Amendment 1 (2003)] | ObGyn/Gastroenterology/Urology | ISO |
| 14243-5 First edition 2019-05 | Implants for surgery – Wear of total knee prostheses – Part 5: Durability performance of the patellofemoral joint | Orthopedic | ISO |
| 25539-1 Second edition 2017-02 | Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses | Cardiovascular | ISO |
| 20160 First edition 2006-05-01 | Implants for surgery – Metallic materials – Classification of microstructures for alpha+beta titanium alloy bars | Materials | ISO |
| Standard for Standby Batteries | 1989 Edition 5 2013-10-02 ANSI November 2018 | General II (ES/EMC) | UL |
| SW91:2018 | Classification of defects in health software | Software/Informatics | ANSI AAMI |
| 14242-3 First edition 2009-03-15 | Implants for surgery – Wear of total hip-joint prostheses – Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] | Orthopedic | ISO |
| 18192-1 Second edition 2011-03-01 | Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] | Orthopedic | ISO |
| 14117 Second edition 2019-09 | Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers implantable cardioverter defibrillators and cardiac resynchronization devices. | Cardiovascular | ISO |
| M52 1st ed. August 2015. | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. | InVitro Diagnostics | CLSI |
| WC-2:2019 Section 6 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs. | Physical Medicine | ANSI RESNA |
| WC-1:2019 Section 13 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces | Physical Medicine | ANSI RESNA |
| 6474-2 Second edition 2019-03 | Implants for surgery – Ceramic materials – Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement | Materials | ISO |
| F688-19 | Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate Sheet and Foil for Surgical Implants (UNS R30035) | Materials | ASTM |
| F2101-14 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials Using a Biological Aerosol of Staphylococcus aureus | General Plastic Surgery/General Hospital | ASTM |
| 42-NF37:2019 | Sodium Chloride Irrigation | General Plastic Surgery/General Hospital | USP |
| 42-NF37:2019 | Sodium Chloride Injection | General Plastic Surgery/General Hospital | USP |
| 42-NF37:2019 | Nonabsorbable Surgical Suture | General Plastic Surgery/General Hospital | USP |
| F749-20 | Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit | Biocompatibility | ASTM |
| F749-13 | Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit | Biocompatibility | ASTM |
| F3287-17e1 | Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method | Sterility | ASTM |
| Std 1708-2014 | Standard for Wearable Cuffless Blood Pressure Measuring Devices [including: Amendment 1 (2019)] | Cardiovascular | IEEE |
| 11980 Third edition 2012-11-15 Corrected version 2012-12-01 | Ophthalmic optics – Contact lenses and contact lens care products – Guidance for clinical investigations | Ophthalmic | ISO |
| 14729 First edition 2001-04-15 | Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] | Ophthalmic | ISO |
| Z80.27-2014 | American National Standard for Ophthalmics – Implantable Glaucoma Devices | Ophthalmic | ANSI |
| EP09c 3rd Edition | Measurement Procedure Comparison and Bias Estimation Using Patient Samples | InVitro Diagnostics | CLSI |
| E2834-12 (Reapproved 2018) | Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA) | Nanotechnology | ASTM |
| 22622 First edition 2019-07 | Implants for surgery – Wear of total ankle-joint prostheses – Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test | Orthopedic | ISO |
| D5151-19 | Standard Test Method for Detection of Holes in Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| 10940 Second edition 2009-08-01 | Ophthalmic instruments – Fundus cameras | Ophthalmic | ISO |
| EP34 1st Edition | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking | InVitro Diagnostics | CLSI |
| S3.5-1997 (Reaffirmed 2017) | American National Standard Methods for Calculation of the Speech Intelligibility Index | Dental/ENT | ANSI |
| F2942-13 | Standard Guide for the In Vitro Axial Bending and Rotational Durability Test of Vascular Stents | Cardiovascular | ASTM |
| 60601-2-27 Edition 3.0 2011-03 | Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] | Cardiovascular | IEC |
| S3.37-1987 (Reaffirmed 2017) | American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids | Dental/ENT | ANSI |
| D5151-06 (Reapproved 2015) | Standard Test Method for Detection of Holes in Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| WC-2:2009 Section 9 | American National Standard for Wheelchairs –Â Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic Tests for Electrically Powered Wheelchairs | Physical Medicine | ANSI RESNA |
| WC-2:2009 Section 10 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of Obstacle-Climbing Ability of Electrically Powered Wheelchairs | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 11 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 13 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces | Physical Medicine | ANSI RESNA |
| 11551 Third eidtion 2019-10 | Optics and optical instruments – Lasers and laser-related equipment – Test method for absorptance of optical laser components | Radiology | ISO |
| 11551 Second edition 2013-12-01 | Optics and optical instruments – Lasers and laser-related equipment – Test method for absorptance of optical laser components | Radiology | ISO |
| 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications – Part 2: Lithium systems | General II (ES/EMC) | IEC |
| 60601-2-28 Edition 3.0 2017-06 | Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | Radiology | IEC |
| 80601-2-12 Second edition 2020-02 | Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | Anesthesiology | ISO |
| TIR38:2019 | Medical device safety assurance case guidance | General Plastic Surgery/General Hospital | AAMI |
| F2313-10 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide | Materials | ASTM |
| 51276 Fourth edition 2019-08 | Practice for use of a polymethylmethacrylate dosimetry system | Sterility | ASTM ISO |
| 11139 First edition 2018-08 | Sterilization of health care products – Vocabulary of terms used in sterilization and related equipment and process standards | Sterility | ISO |
| 18472 Second edition 2018-08 | Sterilization of health care products – Biological and chemical indicators – Test equipment | Sterility | ISO |
| 18472 First edition 2006-06-01 | Sterilization of health care products – Biological and chemical indicators – Test equipment | Sterility | ISO |
| 80601-2-56 Second edition 2017-03 | Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. | General Plastic Surgery/General Hospital | ISO |
| F2638-18 | Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier | Sterility | ASTM |
| EP35 1st Edition | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures | InVitro Diagnostics | CLSI |
| 42-NF37:2019 | <87> Biological Reactivity Test In Vitro – Direct Contact Test | Biocompatibility | USP |
| E3025-16 | Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles | Nanotechnology | ASTM |
| F2100-11 (Reapproved 2018) | Standard Specification for Performance of Materials Used in Medical Face Masks | General Plastic Surgery/General Hospital | ASTM |
| F1378-17 | Standard Specification for Shoulder Prostheses | Orthopedic | ASTM |
| V&V 40-2018 | Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices | General I (QS/RM) | ASME |
| F3320-18 | Standard Guide forCoating Characterization of Drug Coated Balloons | Cardiovascular | ASTM |
| ST77:2013/(R)2018 | Containment devices for reusable medical device sterilization | Sterility | ANSI AAMI |
| 42-NF37:2019 | Absorbable Surgical Suture | General Plastic Surgery/General Hospital | USP |
| 80601-2-30: Edition 2.0 2018-03 | Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers | Cardiovascular | IEC |
| WC-1:2009 Section 3 | American National Standard for Wheelchairs – Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes | Physical Medicine | ANSI RESNA |
| 11073-10101 First edition 2004-12-15 | Health informatics – Point-of-care medical device communication – Part 10101: Nomenclature [Including AMENDMENT 1 (2017)] | Software/Informatics | IEEE ISO |
| 29119-1 First edition 2013-09-01 | Software and systems engineering – Software testing – Part 1: Concepts and definitions | Software/Informatics | IEC IEEE ISO |
| 15142-3 First edition 2003-08-01 | Implants for surgery – Metal intramedullary nailing systems – Part 3: Connection devices and reamer diameter instruments | Orthopedic | ISO |
| Standard No. 131 – 2015 | Dental CAD/CAM Machinable Zirconia Blanks | Dental/ENT | ANSI ADA |
| 80369-3 First Edition 2016-07-01 | Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]. | General I (QS/RM) | ISO |
| /TS 10993-20 First edition 2006-08-01 | Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing of medical devices | Biocompatibility | ISO |
| S3.35-2010 (Reaffirmed 2015) | American National Standard Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions | Dental/ENT | ANSI ASA |
| 20795-1 Second edition 2013-03-01 | Dentistry – Base polymers –Â Part 1: Denture base polymers | Dental/ENT | ISO |
| TR 80001-2-2 Edition 1.0 2012-07 | Application of risk management for IT Networks incorporating medical devices – Part 2-2: Guidance for the disclosure and communication of medical device security needs risks and controls | Software/Informatics | IEC |
| 80601-2-79 First edition 2018-07 | Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment | Anesthesiology | ISO |
| Std 11073-10201-2018 | Health informatics – Point-of-care medical device communication Part 10201: Domain Information Model | Software/Informatics | IEEE |
| 11073-10201 First edition 2004-12-15 | Health informatics – Point-of-care medical device communication – Part 10201: Domain information model | Software/Informatics | IEEE ISO |
| D7103-06 (Reapproved 2013) | Standard Guide for Assessment of Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| 80369-7 First edition 2016-10-15 | Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications | General I (QS/RM) | ISO |
| 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | Biocompatibility | ISO |
| 10993-1 Fourth edition 2009-10-15 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)] | Biocompatibility | ISO |
| Z80.7-2013 (R2018) | American National Standard for Ophthalmic Optics – Intraocular Lenses | Ophthalmic | ANSI |
| 11737-2 Third edition 2019-12 | Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process | Sterility | ISO |
| 11737-2 Second edition 2009-11-15 | Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process | Sterility | ISO |
| ST72:2019 | Bacterial endotoxins – Test methods routine monitoring and alternatives to batch testing | Sterility | ANSI AAMI |
| ST72:2011/(R)2016 | Bacterial endotoxins – Test methods routine monitoring and alternatives to batch testing | Sterility | ANSI AAMI |
| F2038-00 (Reapproved 2011) | Standard Guide for Silicone Elastomers Gels and Foams Used in Medical Applications – Part 1: Formulations and Uncured Materials | Materials | ASTM |
| 15142-1 First edition 2003-08-01 | Implants for surgery – Metal intramedullary nailing systems –Â Part 1: Intramedullary nails | Orthopedic | ISO |
| S12.2-2019 | American National Standard Criteria for Evaluating Room Noise | Dental/ENT | ANSI ASA |
| 17730 First edition 2014-11-01 | Dentistry – Fluoride varnishes | Dental/ENT | ISO |
| Z80.38-2017 | American National Standard for Ophthalmics – Light Hazard from Operation Microscopes Used in Ocular Surgery | Ophthalmic | ANSI |
| ST67:2011/(R)2017 | Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” | Sterility | ANSI AAMI |
| 10993-13 Second edition 2010-06-15 | Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices | Biocompatibility | ISO |
| 62133-1 Edition 1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications – Part 1: Nickel systems | General II (ES/EMC) | IEC |
| 60601-2-28 Edition 2.0 2010-03 | Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | Radiology | IEC |
| HE75:2009/(R)2018 | Human factors engineering – Design of medical devices | General I (QS/RM) | ANSI AAMI |
| 9693-1 First edition 2012-02-15 | Dentistry — Compatibility testing – Part 1: Metal-ceramic systems | Dental/ENT | ISO |
| 11073-91064 First edition 2009-05-01 | Health informatics – Standard communication protocol – Computer-assisted electrocardiography | Software/Informatics | ISO |
| Std 11073-10419:2015 | Health informatics – Personal health device communication – Part 10419: Device Specialization – Insulin Pump | Software/Informatics | IEEE |
| 11073-10419 First edition 2016-06-15 | Health informatics – Personal health device communication – Part 10419: Device specialization – Insulin pump | Software/Informatics | IEEE ISO |
| 62274 First Edition 2005-05 | Medical electrical equipment – Safety of radiotherapy record and verify systems | Radiology | IEC |
| 60601-2-11 Edition 3.0 2013-01 | Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment | Radiology | IEC |
| 52628 First edition 2013-11-15 | Practice for dosimetry in radiation processing | Sterility | ASTM ISO |
| 17664 Second edition 2017-10 | Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices | Sterility | ISO |
| 8836 Fourth edition 2014-10-15 | Suction catheters for use in the respiratory tract | Anesthesiology | ISO |
| 11712 First edition 2009-05-15 | Anaesthetic and respiratory equipment – Supralaryngeal airways and connectors | Anesthesiology | ISO |
| 10079-1 Third Edition 2015-11-01 | Medical suction equipment – Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)] | Anesthesiology | ISO |
| WC-2:2009 Section 14 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 15 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure Documentation and Labeling | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 16 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts – Requirements and Test Methods | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 20 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 22 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures | Physical Medicine | ANSI RESNA |
| 80601-2-80 First edition 2018-07 | Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency | Anesthesiology | ISO |
| S12.2-2008 (Revision of ANSI S12.2-1995) | American National Standard Criteria for Evaluating Room Noise | Dental/ENT | ANSI ASA |
| Z80.35-2018 | American National Standard for Ophthalmics – Extended Depth of Focus Intraocular Lenses | Ophthalmic | ANSI |
| 122-2007 (R2011) | Standard for Photographic Equipment – Ed. 5.0 | Radiology | UL |
| 60976 Edition 2.0 2007-10 | Medical electrical equipment – Medical electron accelators – Functional performance characteristics | Radiology | IEC |
| 11073-20101 First edition 2004-12-15 | Health informatics – Point-of-care medical device communication – Part 20101: Application Profiles – Base Standard | Software/Informatics | IEEE ISO |
| F2739-16 | Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds | Tissue Engineering | ASTM |
| 60812 Edition 3.0 2018-08 | Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA) | General I (QS/RM) | IEC |
| 60812 Second edition 2006-01 | Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA) | General I (QS/RM) | IEC |
| /TR 13121 First edition 2011-05-15 | Nanotechnologies – Nanomaterial risk evaluation | Nanotechnology | ISO |
| MS 5-2018 | Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging | Radiology | NEMA |
| 7886-3 First edition 2005-03-01 | Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization | General Plastic Surgery/General Hospital | ISO |
| 11073-10406 First edition 2012-12-01 | Health informatics – Personal health device communication – Part 10406: Device specialization – Basic electrocardiograph (ECG) (1- to 3-lead ECG) | Software/Informatics | IEEE ISO |
| CI86:2017 | Cochlear implant systems: Requirements for safety functional verification labeling and reliability reporting | Dental/ENT | ANSI AAMI |
| F1984-99 (Reapproved 2018) | Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials | Biocompatibility | ASTM |
| S3.22-2014 | American National Standard Specification of Hearing Aid Characteristics | Dental/ENT | ANSI ASA |
| S3.1 (Reaffirmed 2013) | American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms | Dental/ENT | ANSI |
| F2054/F2054M-13 | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates | Sterility | ASTM |
| ST55:2016 | Table-top steam sterilizers | Sterility | ANSI AAMI |
| F2450-10 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products | Tissue Engineering | ASTM |
| F2602-13 | Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) | Tissue Engineering | ASTM |
| 80601-2-70 First Edition 2015-01-15 | Medical Electrical Equipment – Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment | Anesthesiology | ISO |
| 17510 First Edition 2015-08-01 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories | Anesthesiology | ISO |
| 14243-1 Second edition 2009-11-15 | Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] | Orthopedic | ISO |
| D6977-04 (Reapproved 2016) | Standard Specification for Polychloroprene Examination Gloves for Medical Application | General Plastic Surgery/General Hospital | ASTM |
| D3577-19 | Standard Specification for Rubber Surgical Gloves | General Plastic Surgery/General Hospital | ASTM |
| D3577-09 (Reapproved 2015) | Standard Specification for Rubber Surgical Gloves | General Plastic Surgery/General Hospital | ASTM |
| F899-20 | Standard Specification for Wrought Stainless Steels for Surgical Instruments | Materials | ASTM |
| F2381-10 | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy | Orthopedic | ASTM |
| 14243-3 Second edition 2014-11-01 | Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] | Orthopedic | ISO |
| 14243-3 Second edition 2014-11-01 | Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test | Orthopedic | ISO |
| 60601-1-3 Edition 2.1 2013-04 | Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment | Radiology | IEC |
| 61391-2 Edition 1.0 2010-01 | Ultrasonics – Pulse-echo scanners – Part 2: Measurement of maximum depth of penetration and local dynamic range | Radiology | IEC |
| 60336 Fourth edition 2005-04 | Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Characteristics of focal spots [Including:Â Technical Corrigendum 1 (2006)] | Radiology | IEC |
| 10918-1 First edition 1994-02-15 | Information technology – Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] | Radiology | IEC ISO |
| 61217 Edition 2.0 2011-12 | Radiotherapy equipment – Coordinates movements and scales | Radiology | IEC |
| 5832-12 Second edition 2007-05-01 | Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: Technical Corrigedum 1 (2008)] | Materials | ISO |
| F2394-07 (Reapproved 2017) | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System | Cardiovascular | ASTM |
| F2212-19 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) | Tissue Engineering | ASTM |
| F1800-19 e1 | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements | Orthopedic | ASTM |
| F763-04 (Reapproved 2016) | Standard Practice for Short-Term Screening of Implant Materials | Biocompatibility | ASTM |
| F981-04 (Reapproved 2016) | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone | Biocompatibility | ASTM |
| F1877-16 | Standard Practice for Characterization of Particles | Biocompatibility | ASTM |
| PB70:2012 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities | General Plastic Surgery/General Hospital | ANSI AAMI |
| 10993-18 Second edition 2020-01 | Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process. | Biocompatibility | ISO |
| D5250-19 | Standard Specification for Poly(vinyl chloride) Gloves for Medical Application | General Plastic Surgery/General Hospital | ASTM |
| F899-12b | Standard Specification for Wrought Stainless Steels for Surgical Instruments | Materials | ASTM |
| F3292-19 | Standard Practice for Inspection of Spinal Implants Undergoing Testing | Orthopedic | ASTM |
| /TR 80001-2-4 Edition 1.0 2012-11 | Application of risk management for IT-networks incorporating medical devices — Part 2-4: Application guidance – General implementation guidance for healthcare delivery organization | Software/Informatics | IEC |
| 82304-1 Edition 1.0 2016-10 | Health software – Part 1: General requirements for product safety | Software/Informatics | IEC |
| 18190 First edition 2016-11-01 | Anaesthetic and respiratory equipment – General requirements for airways and related equipment | Anesthesiology | ISO |
| D7866-14 | Standard Specification for Radiation Attenuating Protective Gloves | General Plastic Surgery/General Hospital | ASTM |
| F1875-98 (Reapproved 2014) | Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface | Orthopedic | ASTM |
| 10271 Second edition 2011-08-01 | Dentistry – Corrosion test methods for metallic materials | Dental/ENT | ISO |
| F1813-13 | Standard Specification for Wrought Titanium – 12 Molybdenum – 6 Zirconium – 2 Iron Alloy for Surgical Implant (UNS R58120) | Materials | ASTM |
| F86-13 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants | Materials | ASTM |
| F1586/F1586M-13 | Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) | Materials | ASTM |
| S3.25-2009 (Reaffirmed 2014) | American National Standard For an Occluded Ear Simulator | Dental/ENT | ANSI ASA |
| 22803 First edition 2004-09-01 | Dentistry – Membrane materials for guided tissue regeneration in oral and maxillofacial surgery – Contents of a technical file | Dental/ENT | ISO |
| 24234 Second edition 2015-05-01 | Dentistry – Dental Amalgam | Dental/ENT | ISO |
| 11979-2 Second edition 2014-08-15 | Ophthalmic implants – Intraocular lenses – Part 2: Optical properties and test methods | Ophthalmic | ISO |
| 13212 Third edition 2014-09-01 | Ophthalmic optics – Contact lens care products – Guidelines for determination of shelf-life | Ophthalmic | ISO |
| 18259 First Edition 2014-10-01 | Ophthalmic optics – Contact lens care products – Method to assess contact lens care products with contact lenses in a lens case challenged with bacterial and fungal organisms | Ophthalmic | ISO |
| D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application | General Plastic Surgery/General Hospital | ASTM |
| D6319-10 (Reapproved 2015) | Standard Specification for Nitrile Examination Gloves for Medical Application | General Plastic Surgery/General Hospital | ASTM |
| 8536-4 Sixth edition 2019-09 | Infusion equipment for medical use – Part 4: Infusion sets for single use gravity feed | General Plastic Surgery/General Hospital | ISO |
| F2129-19a | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices | Materials | ASTM |
| F2129-17b | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices | Materials | ASTM |
| WC-2:2009 Section 2 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs | Physical Medicine | ANSI RESNA |
| WC-2:2009 Section 4 | American National Standard for Wheelchairs – Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy Consumption of Electrically Powered Wheelchairs and Scooters for Determination of Theoretical Distance Range | Physical Medicine | ANSI RESNA |
| WC-1:2009 Section 5 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of Dimensions Mass and Maneuvering Space | Physical Medicine | ANSI RESNA |
| 11607-1 Second edition 2019-02 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials sterile barrier systems and packaging systems | Sterility | ISO |
| 52911-1: First Edition 2019-07 | Additive Manufacturing – Design – Part 1: Laser-based powder bed fusion of metals | Materials | ASTM ISO |
| 52911-2: First Edition 2019-09 | Additive Manufacturing – Design – Part 2: Laser-based powder bed fusion of polymers | Materials | ASTM ISO |
| /TS 17137 First edition 2014-05-15 | Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants. | Cardiovascular | ISO |
| F1903-18 | Standard Practice for Testing for Cellular Responses to Particles in vitro | Biocompatibility | ASTM |
| F897-19 | Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws | Orthopedic | ASTM |
| Std 11073-20601-2019 | Health informatics – Personal health device communication – Part 20601: Application profile – Optimized exchange protocol. | Software/Informatics | IEEE |
| F2150-19 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products | Tissue Engineering | ASTM |
| F3275-19 | Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device | Materials | ASTM |
| F3276-19 | Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device | Materials | ASTM |
| WC-1:2009 Section 7 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions | Physical Medicine | ANSI RESNA |
| Std 11073-20601:2014 | Health informatics – Personal health device communication – Part 20601: Application profile – Optimized exchange protocol [including Corrigendum 1 (2015)] | Software/Informatics | IEEE |
| 80601-2-12 First edition 2011-04-15 | Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung ventilators – Critical care ventilators [Including: Technical Corrigendum 1 (2011)] | Anesthesiology | ISO |
| 7886-2 Second edition 2020-04 | Sterile hypodermic syringes for single use – Part 2: Syringes for use with power-driven syringe pumps | General Plastic Surgery/General Hospital | ISO |
| 7886-2 First edition 1996-05-15 | Sterile hypodermic syringes for single use – Part 2:Â Syringes for use with power-driven syringe pumps | General Plastic Surgery/General Hospital | ISO |
| WC-1:2009 Section 26 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters)Â Section 26: Vocabulary | Physical Medicine | ANSI RESNA |
| F3208-19 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices | Materials | ASTM |
| F3208-17 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices | Materials | ASTM |
| F3321-19 | Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices | Materials | ASTM |
| 62366-1 Edition 1.0 2015-02 | Medical devices – Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] | General I (QS/RM) | IEC |
| F3306-19 | Standard Test Method for Ion Release Evaluation of Medical Implants | Materials | ASTM |
| F17-18 | Standard Terminology Relating to Flexible Barrier Packaging | Sterility | ASTM |
| 10993-14 First edition 2001-11-15 | Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics | Biocompatibility | ISO |
| F1904-14 | Standard Practice for Testing the Biological Responses to Particles In Vivo | Biocompatibility | ASTM |
| NS4:2013(R)2017 | Transcutaneous Electrical Nerve Stimulators | Neurology | ANSI AAMI |
| 7176-6 Third edition 2018-06 | Wheelchairs – Part 6:Â Determination of maximum speed acceleration and deceleration of electric wheelchairs | Physical Medicine | ISO |
| F2079-09 (Reapproved 2017) | Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents | Cardiovascular | ASTM |
| 15459-6 Second edition 2014 Corrected 2016 | Information technology – Automatic identification and data capture techniques – Unique identification – Part 6: Groupings | Software/Informatics | IEC ISO |
| 22442-3 First edition 2007-12-15 | Medical devices utilizing animal tissues and their derivatives – Part 3:Â Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. | Tissue Engineering | ISO |
| D1505-18 | Standard Test Method for Density of Plastics by the Density-Gradient Technique | Materials | ASTM |
| F2529-13 | Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) | Tissue Engineering | ASTM |
| 60601-1-11 Edition 2.0 2015-01 | Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | General II (ES/EMC) | IEC |
| 15026-4 First edition 2012-10-01 | Systems and software engineering – Systems and software assurance – Part 4: Assurance in the life cycle | Software/Informatics | IEC ISO |
| QMS24 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 | Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| F3224-17 | Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging | Tissue Engineering | ASTM |
| F1671/F1671M-13 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System | General Plastic Surgery/General Hospital | ASTM |
| M45 3rd Edition | Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria. | InVitro Diagnostics | CLSI |
| F2407-06 (Reapproved 2013) | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | General Plastic Surgery/General Hospital | ASTM |
| E1262-88 (Reapproved 2018) | Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay | Biocompatibility | ASTM |
| F1439-03 (Reapproved 2018) | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials | Biocompatibility | ASTM |
| F2819-10 (Reapproved 2015) | Standard Test Methods for Measurement of Straightness of Bar Rod Tubing and Wire to be used for Medical Devices | Materials | ASTM |
| F3044-14 | Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants | Materials | ASTM |
| F2063-12 | Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants | Materials | ASTM |
| Standard 7351731 Rev. 2.00 2017-02-23 | Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers – An AIM Standard | General II (ES/EMC) | AIM |
| Z80.13-2007 (R2017) | American National Standard for Ophthalmics – Phakic Intraocular Lenses | Ophthalmic | ANSI |
| 11981 Third edition 2017-11 | Ophthalmic optics – Contact lenses and contact lens care products – Determination of physical compatibility of contact lens care products with contact lenses | Ophthalmic | ISO |
| 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) | Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | Anesthesiology | ISO |
| ST50:2004/(R)2018 | Dry heat (heated air) sterilizers | Sterility | ANSI AAMI |
| F1314-13 | Standard Specification for Wrought Nitrogen Strengthened 22 Chromium – 13Â Nickel – 5 Manganese – 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) | Materials | ASTM |
| F601-18 | Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants | Materials | ASTM |
| S3.42-2012/Part 2/ IEC 60118-15:2012 (R2017) | American National Standard Testing Hearing Aids – Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) | Dental/ENT | ANSI ASA |
| S3.45-2009 (Reaffirmed 2014) | American National Standard Procedures for Testing Basic Vestibular Function | Dental/ENT | ANSI |
| S3.46-2013 (R2018) | American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids | Dental/ENT | ANSI ASA |
| 62485-1 Edition 1.0 2015-04 | Safety requirements for secondary batteries and battery installations – Part 1: General safety information. | General II (ES/EMC) | IEC |
| 62485-3 Edition 2.0 2014-07 | Safety requirements for secondary batteries and battery installations – Part 3: Traction batteries | General II (ES/EMC) | IEC |
| E2490-09 (Reapproved 2015) | Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) | Nanotechnology | ASTM |
| 2900-1 First Edition 2017 | Standard for Safety Standard for Software Cybersecurity Network-Connectable Products Part 1: General Requirements | Software/Informatics | ANSI UL |
| 29147 First edition 2014-02-15 | Information technology – Security techniques – Vulnerability disclosure | Software/Informatics | IEC ISO |
| 1998 Third Edition 2013 | Standards for Safety Software in Programmable Components Second Edition. [This Standard contains revisions through and including October 28 2008] | Software/Informatics | ANSI UL |
| 10993-6 Third edition 2016-12-01 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | Biocompatibility | ISO |
| 62443-2-1 Edition 1.0 2010-11 | Industrial communication networks – Network and system security – Part 2-1: Establishing an industrial automation and control system security program | Software/Informatics | IEC |
| 7376 Second edition 2009-08-15 | Anaesthetic and respiratory equipment-Laryngoscopes for tracheal intubation | Anesthesiology | ISO |
| 5366 First edition 2016-10-01 | Anaesthetic and respiratory equipment – Tracheostomy tubes and connectors | Anesthesiology | ISO |
| 5361 Third edition 2016-09-01 | Anaesthetic and respiratory equipment – Tracheal tubes and connectors | Anesthesiology | ISO |
| M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 | Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard – Third Edition | InVitro Diagnostics | CLSI |
| MM23-1st Edition | Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) | InVitro Diagnostics | CLSI |
| 61847: 1998 | Ultrasonics – Surgical systems – Measurement and declaration of the basic output characteristics Ed. 1.0 | Radiology | IEC |
| EC12:2000/(R)2015 | Disposable ECG electrodes | Cardiovascular | ANSI AAMI |
| F2081-06 (Reapproved 2017) | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents | Cardiovascular | ASTM |
| F1983-14 | Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications | Biocompatibility | ASTM |
| 10477 Third edition 2018-06 | Dentistry – Polymer-based crown and veneering materials | Dental/ENT | ISO |
| F647-94 (Reapproved 2014) | Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application | Neurology | ASTM |
| 25841 Third edition 2017-08 | Female condoms — Requirements and test methods | ObGyn/Gastroenterology/Urology | ISO |
| F3335-20 | Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion | Materials | ASTM |
| 52907: First Edition 2019-11 | Additive Manufacturing – Feedstock materials – Methods to characterize metal powders | Materials | ASTM ISO |
| F2450-18 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products | Tissue Engineering | ASTM |
| 11135 Second edition 2014-07-15 | Sterilization of health-care products – Ethylene oxide – Requirements for the development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] | Sterility | ISO |
| 14155 Second edition 2011-02-01 | Clinical investigation of medical devices for human subjects – Good clinical practice [Including: Technical Corrigendum 1 (2011)] | Biocompatibility | ISO |
| MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 | Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| WC-2:2009 Section 6 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of Maximum Speed Acceleration and Deceleration of Electrically Powered Wheelchairs | Physical Medicine | ANSI RESNA |
| 7886-3 Second edition 2020-05 | Sterile hypodermic syringes for single use – Part 3: Auto-disabled syringes for fixed-dose immunization | General Plastic Surgery/General Hospital | ISO |
| WC-2:2009 Section 21 | American National Standard for Wheelchairs – Volume 2 Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters | Physical Medicine | ANSI RESNA |
| D3578-19 | Standard Specification for Rubber Examination Gloves | General Plastic Surgery/General Hospital | ASTM |
| D3578-05 (Reapproved 2015) | Standard Specification for Rubber Examination Gloves | General Plastic Surgery/General Hospital | ASTM |
| D6977-19 | Standard Specification for Polychloroprene Examination Gloves for Medical Application | General Plastic Surgery/General Hospital | ASTM |
| F2739-19 | Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds | Tissue Engineering | ASTM |
| 14243-1 Second edition 2009-11-15 | Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test | Orthopedic | ISO |
| 42-NF37:2019 | <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests | Sterility | USP |
| 42-NF37:2019 | <71> Sterility Tests | Sterility | USP |
| 42-NF37:2019 | <85> Bacterial Endotoxins Test | Sterility | USP |
| F3004-13e1 | Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound | Sterility | ASTM |
| 11137-1 First edition 2006-04-15 | Sterilization of health care products – Radiation – Part 1: Requirements for development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] | Sterility | ISO |
| 13779-3 Second edition 2018-12 | Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity. | Materials | ISO |
| 51818 Third edition 2013-06-01 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV | Sterility | ASTM ISO |
| 51607 Third edition 2013-06-01 | Practice for use of an alanine-EPR dosimery system | Sterility | ASTM ISO |
| F2066-13 | Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) | Materials | ASTM |
| F3260-18 | Standard Test Method for Determining the Flexural Stiffness of Medical Textiles | Materials | ASTM |
| 52910-18 | Additive manufacturing – Design – Requirements guidelines and recommendations | Materials | ASTM ISO |
| F799-11 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537 R31538 R31539) | Materials | ASTM |
| F2313-18 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide | Materials | ASTM |
| 42-NF37:2019 | <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests | Sterility | USP |
| 42-NF37:2019 | <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms | Sterility | USP |
| 42-NF37:2019 | <55> Biological Indicators — Resistance Performance Tests | Sterility | USP |
| 42-NF37:2019 | <1229.5> Biological Indicators for Sterilization | Sterility | USP |
| F3357-19 | Standard Guide for Designing Reusable Medical Devices for Cleanability | Sterility | ASTM |
| Z80.37-2017 | American National Standard for Ophthalmics – Slit-Lamp Microscopes | Ophthalmic | ANSI |
| M44-S3 (2018) | Zone Diameter Interpretive Standards Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement | InVitro Diagnostics | CLSI |
| M24 3rd Edition | Susceptibility Testing of Mycobacteria Nocardiae and other Aerobic Actinomycetes | InVitro Diagnostics | CLSI |
| F3018-17 | Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices | Orthopedic | ASTM |
| 80601-2-55 Second edition 2018-02 | Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | Anesthesiology | ISO |
| 9626 Second edition 2016-08-01 | Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods | General Plastic Surgery/General Hospital | ISO |
| 5840-1 First edition 2015-09-15 | Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements | Cardiovascular | ISO |
| 5840-2:2015 First Edition | Cardiovascular implants – Cardiac valve prostheses –Â Part 2: Surgically implanted heart valve substitutes | Cardiovascular | ISO |
| 8638 Third edition 2010-07-01 | Cadiovascular implants and extracorporeal blood circuit for hemodialyzers hemodialfilters and hemofilters | ObGyn/Gastroenterology/Urology | ISO |
| 26722 Second edition 2014-04-01 | Water treatment equipment for hemodialysis applications and related therapies | ObGyn/Gastroenterology/Urology | ISO |
| 13958 Third edition 2014-04-01 | Concentrates for haemodialysis and related therapies | ObGyn/Gastroenterology/Urology | ISO |
| POCT04 3rd Edition | Essential Tools for Implementation and Management of a Point-of-Care Testing Program | InVitro Diagnostics | CLSI |
| EP07 3rd Edition | Interference Testing in Clinical Chemistry. | InVitro Diagnostics | CLSI |
| M38 3rd Edition | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi | InVitro Diagnostics | CLSI |
| 16087 First edition 2013-10-01 | Implants for surgery – Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants | Orthopedic | ISO |
| 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 | Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces made of metallic ceramic and plastics materials [Including AMENDMENT1 (2016) ] | Orthopedic | ISO |
| 11986 Third edition 2017-11 | Ophthalmic optics – Contact lenses and contact lens care products – Determination of preservative uptake and release | Ophthalmic | ISO |
| F3301-18a | Standard for Additive Manufacturing – Post Processing Methods – Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion | Materials | ASTM |
| 11608-7 First edition 2016-08-01 | Needle-based injection systems for medical use – Requirements and test methods – Part 7: Accessibility for persons with visual impairment | General Plastic Surgery/General Hospital | ISO |
| 11040-4 Third edition 2015-04-01 | Prefilled syringes – Part 4: Glass barrels for injectables | General Plastic Surgery/General Hospital | ISO |
| D5712-15 | Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex Natural Rubber and Elastomeric Products Using the Modified Lowry Method | General Plastic Surgery/General Hospital | ASTM |
| 10555-6 First edition 2015-04-15 | Intravascular catheters – Sterile and single-use catheters – Part 6: Subcutaneous implanted ports | General Plastic Surgery/General Hospital | ISO |
| 8536-9 Second Edition 2015-06-15 | Infusion Equipment for Medical Use – Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment | General Plastic Surgery/General Hospital | ISO |
| 8536-11 Second Edition 2015-06-15 | Infusion Equipment for Medical Use – Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment | General Plastic Surgery/General Hospital | ISO |
| 1642 5th Edition | Lithium Batteries | General II (ES/EMC) | UL |
| ES60601-1:2005/(R)2012 and A1:2012 | C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) | General II (ES/EMC) | ANSI AAMI |
| 51702 Third edition 2013-04-15 | Practice for dosimetry in a gamma facility for radiation processing | Sterility | ASTM ISO |
| F3303-18 | Standard for Additive Manufacturing – Process Characteristics and Performance: Practice for Metal Powder Bed Fusion Process to Meet Critical Applications | Materials | ASTM |
| F2706-18 | Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model | Orthopedic | ASTM |
| F3268-18 | Standard Guide for in vitro Degradation Testing of Absorbable Metals | Materials | ASTM |
| D7386-16 | Standard Practice for Performance Testing of Packages for Single Delivery Systems | General I (QS/RM) | ASTM |
| F2900-11 | Standard Guide for Characterization of Hydrogels used in Regenerative Medicine | Tissue Engineering | ASTM |
| F2383-11 | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) | Tissue Engineering | ASTM |
| F2260-03 (Reapproved 2012)e1 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy | Tissue Engineering | ASTM |
| 15223-1 Third Edition 2016-11-01 | Medical devices – Symbols to be used with medical device labels labelling and information to be supplied – Part 1: General requirements | General I (QS/RM) | ISO |
| F2083-12 | Standard Specification for Total Knee Prosthesis | Orthopedic | ASTM |
| F2789-10 (Reapproved 2015) | Standard Guide for Mechanical and Functional Characterization of Nucleus Devices | Orthopedic | ASTM |
| F2883-11 | Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPS) and as Device for Surgical Implant Applications | Tissue Engineering | ASTM |
| 60601-1-10 Edition 1.1 2013-11 | Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers | General II (ES/EMC) | IEC |
| Standard No. 139-2012 | Dental Base Polymers | Dental/ENT | ANSI ADA |
| TR 80001-2-8 Edition 1.0 2016-05 | Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 | Software/Informatics | IEC |
| 60601-2-43 – Ed. 2.0 2010-03 | Medical electrical equipment – Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures | Radiology | IEC |
| F2943-14 (Reapproved 2019) | Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty | Orthopedic | ASTM |
| F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Sterility | ASTM |
| F3129-16 | Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses | Orthopedic | ASTM |
| 8835-7 First edition 2011-11-01 | Inhalational anaesthesia systems – Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases | Anesthesiology | ISO |
| /TR 60878 Ed. 3.0 b:2015 | Graphical symbols for electrical equipment in medical practice | General I (QS/RM) | IEC |
| F2258-05 (Reapproved 2015) | Standard Test Method for Strength Properties of Tissue Adhesives in Tension | Materials | ASTM |
| F2005-05 (Reapproved 2015) | Standard Terminology for Nickel-Titanium Shape Memory Alloys | Materials | ASTM |
| F2003-02 (Reapproved 2015) | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air | Materials | ASTM |
| 51649 Third edition 2015-03-15 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV | Sterility | ASTM ISO |
| 51707 Third edition 2015-03-15 | Guide for estimating uncertainties in dosimetry for radiation processing | Sterility | ASTM ISO |
| F1472-14 | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) | Materials | ASTM |
| F1854-15 | Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants | Materials | ASTM |
| F3122-14 | Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes | Materials | ASTM |
| D638-14 | Standard Test Method for Tensile Properties of Plastics | Materials | ASTM |
| F2978-13 | Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging | Orthopedic | ASTM |
| F3141-17a | Standard Guide for Total Knee Replacement Loading Profiles | Orthopedic | ASTM |
| 13959 Third edition 2014-04-01 | Water for haemodialysis and related therapies | ObGyn/Gastroenterology/Urology | ISO |
| M60 1st Edition | Performance Standards for Antifungal Susceptibility Testing of Yeasts | InVitro Diagnostics | CLSI |
| F881-94 (Reapproved 2014) | Standard Specification for Silicone Elastomer Facial Implants | General Plastic Surgery/General Hospital | ASTM |
| 60601-2-36 Edition 2.0 2014-04 | Medical electrical equipment – Part 2-36:Â Particular requirements for the safety of equipment for extracorporeally induced lithotripsy | ObGyn/Gastroenterology/Urology | IEC |
| D7661-10 (Reapproved 2017) | Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms | ObGyn/Gastroenterology/Urology | ASTM |
| F2743-11 | Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems | Cardiovascular | ASTM |
| EP37 1st Edition | Supplemental Tables for Interference Testing in Clinical Chemistry | InVitro Diagnostics | CLSI |
| GP41 7th Edition | Collection of Diagnostic Venous Blood Specimens | InVitro Diagnostics | CLSI |
| M27 4th Edition | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts | InVitro Diagnostics | CLSI |
| M07 11th Edition | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically | InVitro Diagnostics | CLSI |
| M02 13th Edition | Performance Standards for Antimicrobial Disk Susceptibility Tests | InVitro Diagnostics | CLSI |
| F3160-16 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants | Materials | ASTM |
| 17296-4 First edition 2014-09-01 | Additive manufacturing – General principles – Part 4: Overview of data processing | Materials | ISO |
| E1061-01 (Reapproved 2014) | Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers | General Plastic Surgery/General Hospital | ASTM |
| 23500 Second edition 2014-04-01 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies | ObGyn/Gastroenterology/Urology | ISO |
| 52915 Second edition 2016-02-15 | Specification for Additive Manufacturing File Format (AMF) Version 1.2 | Materials | ASTM ISO |
| 23908 First edition 2011-06-11 | Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles introducers for catheters and needles used for blood sampling | General Plastic Surgery/General Hospital | ISO |
| 21649 First edition 2006-06-01 | Needle-free injectors for medical use — Requirements and test methods | General Plastic Surgery/General Hospital | ISO |
| TR 80001-2-9 Edition 1.0 2017-01 | Application of risk management for it-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities | Software/Informatics | IEC |
| /TR 80002-1 Edition 1.0 2009-09 | Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software | Software/Informatics | IEC |
| 15026-2 First edition 2011-02-15 | Systems and software engineering – Systems and software assurance – Part 2: Assurance case | Software/Informatics | IEC ISO |
| F2924-14 | Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion | Materials | ASTM |
| D6499-18 | Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products | General Plastic Surgery/General Hospital | ASTM |
| F895-11 (Reapproved 2016) | Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity | Biocompatibility | ASTM |
| Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29 2013 | Corrosion Test Methods | Dental/ENT | ANSI ADA |
| 8325 Second edition 2004-09-15 | Dentistry – Test methods for rotary instruments | Dental/ENT | ISO |
| 20749 First edition 2017-03 | Dentistry – Pre-capsulated dental amalgam | Dental/ENT | ISO |
| 23409 First edition 2011-02-15 | Male Condoms – Requirements and test methods for condoms made from synthetic materials | ObGyn/Gastroenterology/Urology | ISO |
| 4074 Third edition 2015-10-15 | Natural latex rubber condoms – Requirements and test methods | ObGyn/Gastroenterology/Urology | ISO |
| F732-17 | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses | Orthopedic | ASTM |
| E2535-07 (Reapproved 2018) | Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings | Nanotechnology | ASTM |
| F2346-18 | Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs | Orthopedic | ASTM |
| H59-A (Replaces H59-P) | Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. | InVitro Diagnostics | CLSI |
| F2624-12 (Reapproved 2016) | Standard Test Method for Static Dynamic and Wear Assessment of Extra-Discal Single Level Spinal Constructs | Orthopedic | ASTM |
| 5367 Fifth edition 2014-10-15 | Anaesthetic and respiratory equipment — Breathing sets and connectors | Anesthesiology | ISO |
| F2062-00 (Reapproved 2018) | Standard Specification for Square Drive Interconnections on Surgical Instruments | General Plastic Surgery/General Hospital | ASTM |
| F2423-11 (Reapproved 2016) | Standard Guide for Functional Kinematic and Wear Assessment of Total Disc Prostheses | Orthopedic | ASTM |
| D792-13 | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement | Materials | ASTM |
| TR 63183 Edition 1.0 2019-12 | Guidance on error and warning messages for software used in radiotherapy | Radiology | IEC |
| 5834-3 Second edition 2019-02 | Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 3: Accelerated ageing methods | Materials | ISO |
| 13356:2015 Third Edition 2015-09-15 | Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | Materials | ISO |
| 52921 First Edition 2013-06-01 | Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies. | Materials | ASTM ISO |
| 52900 First Edition 2015-12-15 | Additive manufacturing — General principles – Terminology. | Materials | ASTM ISO |
| F2082/F2082M-16 | Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery | Materials | ASTM |
| F2033-12 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic Ceramic and Polymeric Mateirals | Orthopedic | ASTM |
| V-1:2013 | Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection | Anesthesiology | CGA |
| 28319 Second edition 2018-04 | Dentistry – Laser welding and filler materials | Dental/ENT | ISO |
| F3001-14 | Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion | Materials | ASTM |
| F2068-15 | Standard Specification for Femoral Prostheses – Metallic Implants | Orthopedic | ASTM |
| F2077-18 | Test Methods for Intervertebral Body Fusion Devices | Orthopedic | ASTM |
| 19227 First edition 2018-03 | Implants for surgery – Cleanliness of orthopedic implants – General requirements | Orthopedic | ISO |
| 8827 First edition 1988-10-15 | Implants for surgery – Staples with parallel legs for orthopaedic use – General requirements | Orthopedic | ISO |
| 13408-4 First edition 2005-11-01 | Aseptic processing of health care products – Part 4: Clean-in-place technologies | Sterility | ISO |
| 13408-5 First edition 2006-11-15 | Aseptic processing of health care products – Part 5: Sterilization-in-place | Sterility | ISO |
| 14160 Second edition 2011-07-01 | Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization development validation and routine control of a sterilization process for medical devices | Sterility | ISO |
| TS 17665-2:2009-01-15 | Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1 | Sterility | ISO |
| 80369-1 Second edition 2018-11 | Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements | General I (QS/RM) | ISO |
| /TS 17137 Second edition 2019-09 | Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants | Materials | ISO |
| 13782 Second edition 2019-04 | Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant applications | Materials | ISO |
| 13782:1996 | Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant applications | Materials | ISO |
| /TR 13014 First edition 2012-05-15 | Nanotechnologies – Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. | Nanotechnology | ISO |
| 21563 First edition 2013-08-15 | Dentistry – Hydrocolloid impression materials | Dental/ENT | ISO |
| Standard No. 53 – 2008 (Reaffirmed 2013) | Polymer-Based Crown and Bridge Materials | Dental/ENT | ANSI ADA |
| 22112 First edition 2005-11-01 | Dentistry — Artificial teeth for dental prostheses | Dental/ENT | ISO |
| F1611-00 (Reapproved 2018) | Standard Specification for Intramedullary Reamers | Orthopedic | ASTM |
| F1829-17 | Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear | Orthopedic | ASTM |
| 11140-1 Third edition 2014-11-01 | Sterilization of health care products – Chemical indicators – Part 1: General requirements | Sterility | ISO |
| 7491 Second edition 2000-09-01 | Dental materials – Determination of colour stability | Dental/ENT | ISO |
| 10993-11 Third edition 2017-09 | Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | Biocompatibility | ISO |
| F2193-18 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System | Orthopedic | ASTM |
| TR 80001-2-1 Edition 1.0 2012-07 | Application of risk management for IT- networks incorporating medical devices – Part 2-1: Step-by-step risk management of medical IT-networks – Practical applications and examples | Software/Informatics | IEC |
| 22674 Second edition 2016-01-15 | Dentistry – Metallic materials for fixed and removable restorations and appliances | Dental/ENT | ISO |
| F1714-96 (Reapproved 2018) | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices | Orthopedic | ASTM |
| F2580-18 | Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis | Orthopedic | ASTM |
| 14971 Third Edtion 2019-12 | Medical devices – Application of risk management to medical devices | General I (QS/RM) | ISO |
| TR 80001-2-3 Edition 1.0 2012-07 | Application of risk management for IT Networks incorporating medical devices – Part 2-3: Guidance for wireless networks | Software/Informatics | IEC |
| 60601-2-50 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] | General Plastic Surgery/General Hospital | IEC |
| 27020 First edition 2010-12-15 | Dentistry – Brackets and tubes for use in orthodontics | Dental/ENT | ISO |
| 20127 First edition 2005-03-15 | Dentistry – Powered toothbrushes – General requirements and test methods | Dental/ENT | ISO |
| 11979-8 Third edition 2017-04 | Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements | Ophthalmic | ISO |
| 18369-3 Second edition 2017-08 | Ophthalmic optics – Contact lenses – Part 3: Measurement Methods | Ophthalmic | ISO |
| F2102-17 | Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants | Materials | ASTM |
| 7176-19 Second Edition 2008-07-15 | Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] | Physical Medicine | ISO |
| F2347-15 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications | Tissue Engineering | ASTM |
| F2064-17 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications | Tissue Engineering | ASTM |
| E2865-12 (Reapproved 2018) | Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials | Nanotechnology | ASTM |
| F748-16 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices | Biocompatibility | ASTM |
| 4049 Fourth edition 2009-10-01 | Dentistry – Polymer-based restorative materials | Dental/ENT | ISO |
| F2504-05 (Reapproved 2014) | Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices | Dental/ENT | ASTM |
| 11663 Second edition 2014-04-01 | Quality of dialysis fluid for haemodialysis and related therapies | ObGyn/Gastroenterology/Urology | ISO |
| F621-12 (Reapproved 2017) | Standard Specification for Stainless Steel Forgings for Surgical Implants | Materials | ASTM |
| F67-13 (Reapproved 2017) | Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250 UNS R50400 UNS R50550 UNS R50700) | Materials | ASTM |
| 10993-5 Third edition 2009-06-01 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | Biocompatibility | ISO |
| 10993-16 Third edition 2017-05 | Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables | Biocompatibility | ISO |
| 17853 Third edition 2011-03-01 | Wear of implant materials – Polymer and metal wear particles – Isolation and characterization | Orthopedic | ISO |
| 18562-1 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process | Anesthesiology | ISO |
| 25539-1: 2017 | Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses | Cardiovascular | ANSI AAMI ISO |
| XR 28-2013 | Supplemental Requirements for User Information and System Function Related to Dose in CT | Radiology | NEMA |
| 14242-4 First edition 2018-05 | Implants for surgery – Wear of total hip-joint prostheses –Â Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading | Orthopedic | ISO |
| 11491 First edition 2017-07 | Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses | Orthopedic | ISO |
| F3140-17 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements | Orthopedic | ASTM |
| 16038 Second edition 2017-11 | Male condoms – Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms | ObGyn/Gastroenterology/Urology | ISO |
| 8637-1 First edition 2017-11 | Extracorporeal systems for blood purification — Part 1: Haemodialysers haemodiafilters haemofilters and haemoconcentrators | ObGyn/Gastroenterology/Urology | ISO |
| D3492-16 | Standard Specification for Rubber Contraceptives (Male Condoms) | ObGyn/Gastroenterology/Urology | ASTM |
| F1609-08 (Reapproved 2014) | Standard Specification for Calcium Phosphate Coatings for Implantable Materials | Materials | ASTM |
| F648-14 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | Materials | ASTM |
| F3109-16 | Standard Test Method for Verification of Multi-Axis Force Measuring Platforms | Materials | ASTM |
| F3107-14 | Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems | Orthopedic | ASTM |
| M11 9th Edition | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. | InVitro Diagnostics | CLSI |
| M48-A 2nd Edition | Laboratory Detection and Identification of Mycobacteria | InVitro Diagnostics | CLSI |
| F754-08 (Reapproved 2015) | Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders | Materials | ASTM |
| F3302-18 | Standard for Additive Manufacturing – Finished Part Properties – Standard Specification for Titanium Alloys via Powder Bed Fusion | Materials | ASTM |
| F1801-97 (Reapproved 2014) | Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials | Materials | ASTM |
| F2255-05 (Reapproved 2015) | Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading | Materials | ASTM |
| F2024-10 (Reapproved 2016) | Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings | Materials | ASTM |
| F1635-16 | Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants | Materials | ASTM |
| 14242-2 Second edition 2016-09-15 | Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement | Orthopedic | ISO |
| 10555-1 Second edition 2013-06-15 | Intravascular catheters – Sterile and single-use intravascular catheters – Part 1: General requirements [Including AMENDMENT 1 (2017)] | General Plastic Surgery/General Hospital | ISO |
| F703-18 | Standard Specification for Implantable Breast Prostheses | General Plastic Surgery/General Hospital | ASTM |
| 13408-2 Second edition 2018-01 | Aseptic processing of health care products – Part 2: Sterilizing filtration. | Sterility | ISO |
| ST41:2008/(R)2018 | Ethylene oxide sterilization in health care facilities:Â Safety and effectiveness | Sterility | ANSI AAMI |
| 10139-1 Third edition 2018-03 | Dentistry – Soft lining materials for removable dentures – Part 1: Materials for short-term use | Dental/ENT | ISO |
| TIR 41:2011/(R)2017 | Technical Information Report Active implantable medical devices – Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators | Cardiovascular | AAMI |
| F1581-08 (Reapproved 2016) | Standard Specification for Composition of Anorganic Bone for Surgical Implants | Materials | ASTM |
| 7206-4 Third edition 2010-06-15 | Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] | Orthopedic | ISO |
| Specification No. 39 (Reaffirmed 2011) | Pit and Fissure Sealants | Dental/ENT | ANSI ADA |
| F2778-09 (Reapproved 2015) | Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR) | Materials | ASTM |
| F640-12 | Standard Test Methods for Determining Radiopacity for Medical Use | Materials | ASTM |
| F1814-15 | Standard Guide for Evaluating Modular Hip and Knee Joint Components | Orthopedic | ASTM |
| 60601-1-8 Edition 2.1 2012-11 | Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | General I (QS/RM) | IEC |
| 80369-20 First edition 2015-05-15 | Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods | General I (QS/RM) | ISO |
| 7864 Fourth edition 2016-08-01 | Sterile hypodermic needles for single use – Requirements and test methods | General Plastic Surgery/General Hospital | ISO |
| F2847-17 | Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments | Materials | ASTM |
| 13781 Second edition 2017-07 | Implants for surgery – Homopolymers copolymers and blends on poly(lactide) – In vitro degradation testing | Materials | ISO |
| F382-17 | Standard Specification and Test Method for Metallic Bone Plates | Orthopedic | ASTM |
| 18369-4 Second edition 2017-08 | Ophthalmic optics – Contact lenses – Part 4: Physicochemical properties of contact lens materials | Ophthalmic | ISO |
| MS 3-2008 (R2014) | Determination of Image Uniformity in Diagnostic Magnetic Resonance Images | Radiology | NEMA |
| 8537 Third edition 2016-03-15 | Sterile single-use syringes with or without needle for insulin | General Plastic Surgery/General Hospital | ISO |
| F3091/F3091M-14 | Standard Specification for Powder Bed Fusion of Plastic Materials | Materials | ASTM |
| Standard No. 96-2012 | Dental Water-based Cements | Dental/ENT | ANSI ADA |
| F603-12 (Reapproved 2016) | Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application | Materials | ASTM |
| RT2:2017 | Radiation therapy readiness check | Radiology | AAMI |
| /AMS2750 Rev. E 2012-07 | Pyrometry | Materials | SAE |
| MS 12-2016 | Quantification and Mapping of Geometric Distortion for Special Applications | Radiology | NEMA |
| I/LA-20 3rd Edition (Replaces I/LA20-A3) | Analytical Performance Characteristics Quality Assurance and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities | InVitro Diagnostics | CLSI |
| C57 1st Edition | Mass Spectrometry for Androgen and Estrogen Measurements in Serum | InVitro Diagnostics | CLSI |
| M58 1st Edition | Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry | InVitro Diagnostics | CLSI |
| 11073-10417 Third edition 2017-04 | Health informatics – Personal health device communication – Part 10417: Device specialization – Glucose meter | Software/Informatics | IEEE ISO |
| Std 11073-10422-2016 | Health informatics – Personal health device communication Part 10422: Device Specialization – Urine Analyzer | Software/Informatics | IEEE |
| 20857 First edition 2010-08-15 | Sterilization of health care products – Dry heat – Requirements for the development validation and routine control of a sterilization process for medical devices | Sterility | ISO |
| 13408-3 First edition 2006-09-15 | Aseptic processing of health care products – Part 3: Lyophilization | Sterility | ISO |
| 10079-2 Third Edition 2014-05-01 | Medical suction equipment – Part 2: Manually powered suction equipment | Anesthesiology | ISO |
| NS28:1988/(R) 2015 | Intracranial pressure monitoring devices | Neurology | AAMI |
| 14708-3 Second edition 2017-04 | Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators | Neurology | ISO |
| F384-17 | Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices | Orthopedic | ASTM |
| F543-17 | Standard Specification and Test Methods for Metallic Medical Bone Screws | Orthopedic | ASTM |
| F2180-17 | Standard Specification for Metallic Implantable Strands and Cables | Orthopedic | ASTM |
| F2028-17 | Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation | Orthopedic | ASTM |
| 60601-1-12 Edition 1.0 2014-06 | Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment | General II (ES/EMC) | IEC |
| C63.16-2016 (Revision of ANSI C63.16-1993) | American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment | General II (ES/EMC) | ANSI IEEE |
| F2902-16 | Standard Guide for Assessment of Absorbable Polymeric Implants | Materials | ASTM |
| TIR 49:2013/(R)2020 | Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments | General I (QS/RM) | AAMI |
| Standards Publication XR 28-2018 | Supplemental Requirements for User Information and System Function Related to Dose in CT | Radiology | NEMA |
| F2565-13 | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications | Materials | ASTM |
| 7206-12 First edition 2016-10-01 | Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells | Orthopedic | ISO |
| 7206-13 First edition 2016-07-01 | Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components | Orthopedic | ISO |
| EN 1615:2000 | Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing | ObGyn/Gastroenterology/Urology | CEN |
| F755-99 (Reapproved 2011) | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants | Materials | ASTM |
| /TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | General II (ES/EMC) | IEC |
| C63.15-2017 (Revision of ANSI C63.15-2010) | American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment | General II (ES/EMC) | ANSI IEEE |
| 60601-2-68 Edition 1.0 2014-09 | Medical electrical equipment – Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators light ion beam therapy equipment and radionuclide beam therapy equipment | Radiology | IEC |
| WC-1:2019 Section 22 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures | Physical Medicine | ANSI RESNA |
| WC-1:2019 Section 26 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters)Â Section 26: Vocabulary | Physical Medicine | ANSI RESNA |
| F2267-04 (Reapproved 2018) | Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | Orthopedic | ASTM |
| /TS 10993-19 First edition 2006-06-01 | Biological evaluation of medical devices – Part 19: Physico-chemical morphological and topographical characterization of materials | Biocompatibility | ISO |
| 60601-2-37 Edition 2.1 2015 | Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | Radiology | IEC |
| 7176-2 Third edition 2017-10 | Wheelchairs – Part 2:Determination of dynamic stability of electrically powered wheelchairs | Physical Medicine | ISO |
| WC-2:2019 Section 10 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Physical Medicine | ANSI RESNA |
| 10993-10 Third Edition 2010-08-01 | Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization | Biocompatibility | ISO |
| 60601-2-33 Ed. 3.2 b:2015 | Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | Radiology | IEC |
| 18562-2 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter | Anesthesiology | ISO |
| WC-1:2019 Section 3 | American National Standard for Wheelchairs – Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes | Physical Medicine | ANSI RESNA |
| A18.1-2017 | Safety Standard for Platform Lifts and Stairway Chairlifts | Physical Medicine | ASME |
| 14708-1 Second edition 2014-08-15 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety marking and for information to be provided by the manufacturer | Cardiovascular | ISO |
| F3211-17 | Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices | Cardiovascular | ASTM |
| ST40:2004/(R)2018 | Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities | Sterility | ANSI AAMI |
| WC-1:2019 Section 15 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure Documentation and Labeling | Physical Medicine | ANSI RESNA |
| WC-1:2019 Section 16 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts – Requirements and Test Methods | Physical Medicine | ANSI RESNA |
| F1839-08 (Reapproved 2016) | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments | Orthopedic | ASTM |
| F1855-00 (Reapproved 2011) | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications | Materials | ASTM |
| 11542-2 First edition 1998-11-15 | Plastics – Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials – Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] | Materials | ISO |
| WC-1:2019 Section 7 | American National Standard for Wheelchairs – Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions | Physical Medicine | ANSI RESNA |
| 29701 First edition 2010-09-15 | Nanotechnologies – Endotoxin test on nanomaterial samples for in vitro systems – Limulus amebocyte lysate (LAL) test. | Nanotechnology | ISO |
| F3259-17 | Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds | Tissue Engineering | ASTM |
| 29943-2 First edition 2017-07 | Condoms — Guidance on clinical studies — Part 2: Female condoms clinical function studies based on self-reports. | ObGyn/Gastroenterology/Urology | ISO |
| F983-86 (Reapproved 2018) | Standard Practice for Permanent Marking of Orthopaedic Implant Components | Orthopedic | ASTM |
| 60601-2-64 Edition 1.0 2014-09 | Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment | Radiology | IEC |
| S20.20-2014 | Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) | General I (QS/RM) | ANSI ESD |
| D4332-14 | Standard Practice for Conditioning Containers Packages or Packaging Components for Testing | General I (QS/RM) | ASTM |
| 11073-10472 First edition 2012-11-01 | Health informatics – Personal health device communication — Part 10472: Device specialization – Medication monitor | Software/Informatics | IEEE ISO |
| F2228-13 | Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method | Sterility | ASTM |
| 6009 Fourth edition 2016-08-01 | Hypodermic needles for single use – Colour coding for identification. | General Plastic Surgery/General Hospital | ISO |
| 10079-3 Third Edition 2014-05-01 | Medical suction equipment – Part 3: Suction equipment powered from a vacuum or positive pressure gas source | Anesthesiology | ISO |
| 81060-1 First edition 2007-12-01 | Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type | Cardiovascular | ISO |
| 14708-5 First edition 2010-02-01 | Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices | Cardiovascular | ISO |
| 61145 (1992-05) | Calibration and usage of ionization chamber systems for assay of radionuclides | Radiology | IEC |
| C29-A2 (Replaces C29-A) | Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method;Â Approved Standard – Second Edition. | InVitro Diagnostics | CLSI |
| C31-A2 (Replaces C31-A) | Ionized Calcium Determinations:Â Precollection Variables Specimen Choice Collection and Handling; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| C37-A | Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline | InVitro Diagnostics | CLSI |
| C39-A (Replaces C39-P) | A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard | InVitro Diagnostics | CLSI |
| 8009 Second edition 2014-11-15 | Mechanical contraceptives – Reusable natural and silicone rubber contraceptive diaphragms – Requirements and tests | ObGyn/Gastroenterology/Urology | ISO |
| 14730 Second edition 2014-10-01 | Ophthalmic optics – Contact lens care products – Antimicrobial preservative efficacy testing and guidance on determining discard date | Ophthalmic | ISO |
| 11979-6 Third edition 2014-10-01 | Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability testing | Ophthalmic | ISO |
| Z80.10-2014 | American National Standard for Ophthalmics – Ophthalmic Instruments – Tonometers | Ophthalmic | ANSI |
| 14457 First edition 2012-09-15 | Dentistry – Handpieces and motors | Dental/ENT | ISO |
| F2147-01 (Reapproved 2016) | Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens | Biocompatibility | ASTM |
| F1295-16 | Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) | Materials | ASTM |
| 20795-2 Second edition 2013-03-01 | Dentistry – Base polymers – Part 2: Orthodontic base polymers | Dental/ENT | ISO |
| Std 11073-10417-2015 | Health Informatics – Personal Health Device Communication Part 10417: Device Specialization – Glucose Meter | Software/Informatics | IEEE |
| F1886/F1886M-16 | Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | Sterility | ASTM |
| 11138-1 Third edition 2017-03 | Sterilization of health care products – Biological indicators – Part 1: General requirements | Sterility | ISO |
| C63.27-2017 | American National Standard for Evaluation of Wireless Coexistence | General II (ES/EMC) | ANSI IEEE |
| 5838-1 Third edition 2013-03-01 | Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements | Orthopedic | ISO |
| C62-A | Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. | InVitro Diagnostics | CLSI |
| EP19 2nd Edition (Replaces EP19-R) | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures | InVitro Diagnostics | CLSI |
| 51608 Second edition 2015-03-15 | Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV | Sterility | ASTM ISO |
| D3772-15 | Standard Specification for Industrial Rubber Finger Cots | General Plastic Surgery/General Hospital | ASTM |
| NU 1-2012 | Performance Measurements of Gamma Cameras | Radiology | NEMA |
| XR 24-2008 (R2014) | Primary user controls for interventional angiography x-ray equipment | Radiology | NEMA |
| XR 27 Amendment 1-2013 | X-ray equipment for interventional procedures – User Quality Control Mode | Radiology | NEMA |
| F565-04 (Reapproved 2018) | Standard Practice for Care and Handling of Orthopedic Implants and Instruments | Orthopedic | ASTM |
| F1541-17 | Standard Specification and Test Methods for External Skeletal Fixation Devices | Orthopedic | ASTM |
| F1978-18 | Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser | Materials | ASTM |
| F560-17 | Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200 UNS R05400) | Materials | ASTM |
| F3374-19 | Standard Guide for Active Fixation Durability of Endovascular Prostheses | Cardiovascular | ASTM |
| WC-2:2019 Section 2 | American National Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs | Physical Medicine | ANSI RESNA |
| F2459-18 | Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis | Materials | ASTM |
| 18562-3 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds | Anesthesiology | ISO |
| 42-NF37:2019 | <861> Sutures – Diameter | General Plastic Surgery/General Hospital | USP |
| 42-NF37:2019 | <871> Sutures – Needle Attachment | General Plastic Surgery/General Hospital | USP |
| 42-NF37:2019 | Sterile Water for Irrigation | General Plastic Surgery/General Hospital | USP |
| 42-NF37:2019 | Heparin Lock Flush Solution | General Plastic Surgery/General Hospital | USP |
| 5359 Fourth edition 2014-10-01 | Anaesthetic and respiratory equipment – Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)] | Anesthesiology | ISO |
| 18082 First edition 2014-06-15 | Anaesthetic and respiratory equipment – Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)] | Anesthesiology | ISO |
| F2825-18 | Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery | Sterility | ASTM |
| F1800-12 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements | Orthopedic | ASTM |
| F2381-19 | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy | Orthopedic | ASTM |
| 60601-2-2 Edition 6.0 2017-03 | Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | General Plastic Surgery/General Hospital | IEC |
| 5356-1 Third edition 2004-05-15 | Anaesthetic and respiratory equipment – Conical connectors: Part 1: Cones and sockets | Anesthesiology | ISO |
| 60601-2-10 Edition 2.1 2016-04 | Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | Neurology | IEC |
| F1147-05 (Reapproved 2017)e1 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings | Materials | ASTM |
| D7160-16 | Standard Practice for Determination of Expiration Dating for Medical Gloves | General Plastic Surgery/General Hospital | ASTM |
| 60601-2-21 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] | General Plastic Surgery/General Hospital | IEC |
| F1840-10 (Reapproved 2016) | Standard Terminology for Surgical Suture Needles | General Plastic Surgery/General Hospital | ASTM |
| F2885-17 | Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications | Materials | ASTM |
| F2886-17 | Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications | Materials | ASTM |
| 11607-2 Second edition 2019-02 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming sealing and assembly processes | Sterility | ISO |
| F2848-17 | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns | Materials | ASTM |
| 52901 First edition 2017-08 | Standard Guide for Additive Manufacturing – General Principles – Requirements for Purchased AM Parts | Materials | ASTM ISO |
| F1925-17 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants | Materials | ASTM |
| F2537-06 (Reapproved 2017) | Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion | Materials | ASTM |
| 13408-7 First edition 2012-08-01 | Aseptic processing of health care products – Part 7: Alternate processes for medical devices and combination products | Sterility | ISO |
| 17665-1 First edition 2006-08-15 | Sterilization of health care products – Moist heat – Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices | Sterility | ISO |
| 15882 Second edition 2008-09-01 | Sterilization of health care products – Chemical indicators – Guidance for selection use and interpretation of results | Sterility | ISO |
| 14161 Second edition 2009-09-15 | Sterilization of health care products – Biological indicators – Guidance for the selection use and interpretation of results | Sterility | ISO |
| 14937 Second edition 2009-10-15 | Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices | Sterility | ISO |
| 7886-1 Second edition 2017-05 | Sterile hypodermic syringes for single use – Part 1: Syringes for manual use | General Plastic Surgery/General Hospital | ISO |
| 80601-2-59 Edition 2.0 2017-09 | Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening | General Plastic Surgery/General Hospital | IEC |
| F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | General Plastic Surgery/General Hospital | ASTM |
| F2004-17 | Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis | Materials | ASTM |
| 14644-5 First edition 2004-08-15 | Cleanrooms and associated controlled environments – Part 5: Operations | Sterility | ISO |
| 60601-2-25 Edition 2.0 2011-10 | Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | Cardiovascular | IEC |
| 27186 First edition 2010-03-15 | Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements | Cardiovascular | ISO |
| 25539-3 First edition 2011-12-01 | Cardiovascular implants – Endovascular devices – Part 3: Vena cava filters | Cardiovascular | ISO |
| 25539-2 Second edition 2012-12-01 | Cardiovascular implants – Endovascular devices – Part 2: Vascular stents | Cardiovascular | ISO |
| 18562-4 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate | Anesthesiology | ISO |
| 62667 Edition 1.0 2017-08 | Medical electrical equipment – Medical light ion beam equipment – Performance characteristics | Radiology | IEC |
| F3293-18 | Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices | Sterility | ASTM |
| 11737-1 Third edition 2018-01 | Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on product | Sterility | ISO |
| F3039-15 | Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration | Sterility | ASTM |
| 60601-1-2 Edition 4.0 2014-02 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests | General II (ES/EMC) | IEC |
| 18250-3 First edition 2018-06 | Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 3: Enteral application | General I (QS/RM) | ISO |
| F366-17 | Standard Specification for Fixation Pins and Wires | Orthopedic | ASTM |
| F564-17 | Standard Specification and Test Methods for Metallic Bone Staples | Orthopedic | ASTM |
| MS 8-2016 | Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems | Radiology | NEMA |
| 80369-5: Edition 1.0 2016-03 | Small-bore connectors for liquids and gases in healthcare applications – Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017)] | General I (QS/RM) | IEC |
| 13408-6 First edition 2005-06-15 | Aseptic processing of health care products – Part 6: Isolator systems [Including: Amendment 1 (2013)] | Sterility | ISO |
| 13408-1 Second edition 2008-06-15 | Aseptic processing of health care products – Part 1: General requirements [Including: Amendment 1 (2013)] | Sterility | ISO |
| 4823 Fourth edition 2015-08-01 | Dentistry – Elastometric impression materials | Dental/ENT | ISO |
| F719-81 (Reapproved 2012) | Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation | Biocompatibility | ASTM |
| F1089-18 | Standard Test Method for Corrosion of Surgical Instruments | Materials | ASTM |
| F2458-05 (Reapproved 2015) | Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants | Materials | ASTM |
| 11810 Second edition 2015-12-15 | Lasers and laser-related equipment – Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers – Primary ignition penetration flame spread and secondary ignition | General Plastic Surgery/General Hospital | ISO |
| F2119-07 (Reapproved 2013) | Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | Materials | ASTM |
| Standard No. 75 (Reaffirmed 2014) | Resilient Lining Materials for Removable Dentures Part 1: Short-Term Materials | Dental/ENT | ANSI ADA |
| Standard No. 17 (Reaffirmed 2014) | Denture Base Temporary Relining Resins | Dental/ENT | ANSI ADA |
| G175-13 | Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications | Anesthesiology | ASTM |
| C-9:2013 | Standard Color Marking of Compressed Gas Containers for Medical Use | Anesthesiology | CGA |
| S3.13-1987 (Reaffirmed 2012) | American National Standard Mechanical Coupler for Measurement of Bone Vibrators | Dental/ENT | ANSI |
| S12.65-2006 (Reaffirmed 2011) | American National Standard For Rating Noise with Respect to Speech Interference | Dental/ENT | ANSI ASA |
| F2502-11 | Standard Specification and Test Methods for Methods for Absorbable Plates and Screws for Internal Fixation Implants | Orthopedic | ASTM |
| 7176-14 Second edition 2008-02-15 | Wheelchairs – Part 14: Power and control systems for electrically powered wheelchairs and scooters – Requirements and test methods | Physical Medicine | ISO |
| D6976-13R18 | Standard Specification for Rubber Contraceptives – Vaginal Diaphragms | ObGyn/Gastroenterology/Urology | ASTM |
| F2146-13 | Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) | Materials | ASTM |
| F136-13 | Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) | Materials | ASTM |
| F623 -99 (Reapproved 2013) | Standard Performance Specification for Foley Catheter | ObGyn/Gastroenterology/Urology | ASTM |
| 8600-4 Second Edition 2014-03-15 | Endoscopes – Medical endoscopes and certain accessories – Part 4:Â Determination of maximum width of insertion portion | ObGyn/Gastroenterology/Urology | ISO |
| F1798-13 | Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants | Orthopedic | ASTM |
| 7206-6 Second edition 2013-11-15 | Implants for surgery – Partial and total hip joint prostheses – Part 6: Determination of endurance properties of head and neck region of stemmed femoral components | Orthopedic | ISO |
| 7198 Second edition 2016-08-01 | Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches | Cardiovascular | ISO |
| F1441-03 (Reapproved 2014) | Standard Specification for Soft-Tissue Expander Devices | General Plastic Surgery/General Hospital | ASTM |
| 11608-1 Third edition 2014-12-15 | Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems | General Plastic Surgery/General Hospital | ISO |
| M40-A2 | Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition. | InVitro Diagnostics | CLSI |
| 11608-3 Second edition 2012-10-01 | Needle based injection systems for medical use – Requirements and test methods – Part 3: Finished containers | General Plastic Surgery/General Hospital | ISO |
| 60601-2-34 Edition 3.0 2011-05 | Medical electrical equipment – Part 2-34:Â Particular requirements for the basic safety including essential performance of invasive blood pressure monitoring equipment | Cardiovascular | IEC |
| 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability | General I (QS/RM) | IEC |
| F2211-13 | Standard Classification for Tissue Engineered Medical Products (TEMPs) | Tissue Engineering | ASTM |
| EP15-A3 | User Verification of Precision and Estimation of Bias; Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| MM09-A2 (Replaces MM09-A) | Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline — Second Edition | InVitro Diagnostics | CLSI |
| M23 Fourth Edition (Replaces M23-A3) | Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. | InVitro Diagnostics | CLSI |
| RP-27.1-2015 | Recommended Practice for Photobiological Safety for Lamps and Lamp Systems – General Requirements | Radiology | ANSI IES |
| 7176-8 Second editon 2014-12-15 | Wheelchairs – Part 8: Requirements and test methods for static impact and fatigue strengths | Physical Medicine | ISO |
| F750-87 (Reapproved 2012) | Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse | Biocompatibility | ASTM |
| F1408-97 (Reapproved 2013) | Standard Practice for Subcutaneous Screening Test for Implant Materials | Biocompatibility | ASTM |
| Z1.9-2003 (R2018) | Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming | General I (QS/RM) | ANSI |
| F139-12 | Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) | Materials | ASTM |
| E647-15 | Standard Test Method for Measurement of Fatigue Crack Growth Rates | Materials | ASTM |
| 5832-11 Second edition 2014-09-15 | Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy | Materials | ISO |
| 8600-1 Fourth Edition 2015-10-15 | Endoscopes – Medical endoscopes and endotherapy devices — Part 1: General requirements | ObGyn/Gastroenterology/Urology | ISO |
| Z80.21-2010 (R2015) | American National Standard for Ophthalmics – Instruments – General-Purpose Clinical Visual Acuity Charts | Ophthalmic | ANSI |
| MM03-3rd Edition (Replaces MM03-A2) | Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline | InVitro Diagnostics | CLSI |
| F746-04 (Reapproved 2014) | Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials | Materials | ASTM |
| F2256-05 (Reapproved 2015) | Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading | Materials | ASTM |
| 27185 First edition 2012-02-15 | Cardiac Rhythm Management Devices – Symbols to be Used With Cardiac Rhythm Management Device Labels and Information to be Supplied – General Requirements | Cardiovascular | ISO |
| 5840-3 First edition 2013-03-01 | Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques | Cardiovascular | ISO |
| F3207-17 | Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model | Tissue Engineering | ASTM |
| 29943-1 First edition 2017-07. | Condoms — Guidance on clinical studies — Part 1: Male condoms clinical function studies based on self-reports | ObGyn/Gastroenterology/Urology | ISO |
| 5362 Fourth edition 2006-06-01 | Anaesthetic Reservoir Bags | Anesthesiology | ISO |
| 60601-2-45 Edition 3.1 2015 | Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | Radiology | IEC |
| F720-17 | Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test | Biocompatibility | ASTM |
| 5832-2 Fourth edition 2018-03 | Implants for surgery – Metallic materials – Part 2:Â Unalloyed titanium | Materials | ISO |
| F1044-05 (Reapproved 2017)e1 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings | Materials | ASTM |
| F2213-17 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | Materials | ASTM |
| 2900-2-1 First Edition 2017 | Standard for Safety Software Cybersecurity for Network-Connectable Products Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems | Software/Informatics | ANSI UL |
| 10993-12 Fourth edition 2012-07-01 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials | Biocompatibility | ISO |
| ST79:2017 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | Sterility | ANSI AAMI |
| F756-17 | Standard Practice for Assessment of Hemolytic Properties of Materials | Biocompatibility | ASTM |
| 10993-3 Third edition 2014-10-1 | Biological evaluation of medical devices – Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity | Biocompatibility | ISO |
| 10993-4 Third edition 2017-04 | Biological evaluation of medical devices–Part 4: Selection of tests for interactions with blood | Biocompatibility | ISO |
| 5832-3 Fourth edition 2016-10-15 | Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy | Materials | ISO |
| /TS 11405 Third edition 2015-02-01 | Dentistry – Testing of adhesion to tooth structure | Dental/ENT | ISO |
| E825-98 (Reapproved 2016) | Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature | General Plastic Surgery/General Hospital | ASTM |
| E1104-98 (Reapproved 2016) | Standard Specification for Clinical Thermometer Probe Covers and Sheaths | General Plastic Surgery/General Hospital | ASTM |
| F2393-12 (Reapproved 2016) | Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications | Materials | ASTM |
| 1135-4 Sixth edition 2015-12-01 | Transfusion equipment for medical use-Part 4: Transfusion sets for single use gravity feed | General Plastic Surgery/General Hospital | ISO |
| E1965-98 (Reapproved 2016) | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature | General Plastic Surgery/General Hospital | ASTM |
| F1608-16 | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) | Sterility | ASTM |
| F2091-15 | Standard Specification for Acetabular Prostheses | Orthopedic | ASTM |
| 7176-1 Third edition 2014-10-01 | Wheelchairs – Part 1:Â Determination of static stability | Physical Medicine | ISO |
| F3212-16 | Standard Test Method for Coring Testing of Huber Needles | General Plastic Surgery/General Hospital | ASTM |
| 15459-4 Third edition 2014 Corrected 2016 | Information technology – Automatic identification and data capture techniques – Unique identification – Part 4: Individual products and product packages | Software/Informatics | IEC ISO |
| 646 Third edition 1991-12-15 | Information technology – IS0 7-bit coded character set for information interchange | Software/Informatics | IEC ISO |
| 13179-1 First edition 2014-06-01 | Implants for surgery–Plasma-sprayed unalloyed titanium coatings on metallic surgical implants — Part 1: General requirements | Materials | ISO |
| 16628 First edition 2008-11-15 | Tracheobronchial tubes-Sizing and marking | Anesthesiology | ISO |
| Z80.18-2016 | American National Standard for Ophthalmics – Contact Lens Care Products – Vocabulary Performance Specifications and Test Methodology | Ophthalmic | ANSI |
| 11073-10425 First edition 2016-06-15 | Health informatics – Personal health device communication – Part 10425: Device specialization – Continuous glucose monitor (CGM) | Software/Informatics | IEEE ISO |
| Standard No. 119-2015 | Manual Toothbrushes | Dental/ENT | ANSI ADA |
| 60601-2-20 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)] | General Plastic Surgery/General Hospital | IEC |
| 60601-2-19 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | General Plastic Surgery/General Hospital | IEC |
| 11140-5 Second edition 2007-03-15 | Sterilization of health care products – Chemical indicators – Part 5: Class 2 indicators for Bowie and Dick-type air removal tests | Sterility | ISO |
| 11137-2 Third edition 2013-06-01 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose | Sterility | ISO |
| EP25-A (Replaces EP25-P) | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. | InVitro Diagnostics | CLSI |
| M43-A | Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. | InVitro Diagnostics | CLSI |
| MM01-A3 (Replaces MM01-A2) | Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| MM06-A2 (Replaces MM06-A) | Quantitative Molecular Methods for Infectious Diseeases; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| 8600-5 First edition 2005-03-15 | Optics and photonics – Medical endoscopes and endotherapy devices – Part 5: Determination of optical resolution of rigid endoscopes with optics | ObGyn/Gastroenterology/Urology | ISO |
| 8600-6 First edition 2005-03-15 | Optics and photonics – Medical endoscopes and endotherapy devices – Part 6: Vocabulary | ObGyn/Gastroenterology/Urology | ISO |
| 7494-2 Second edition 2015-04-01 | Dentistry – Dental units – Part 2: Air water suction and waste water systems | Dental/ENT | ISO |
| GP34-A (Replaces GP34-P) | Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance | InVitro Diagnostics | CLSI |
| I/LA28-A2 | Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. | InVitro Diagnostics | CLSI |
| 15752 Second edition 2010-01-15 | Ophthalmic instruments – Endoilluminators – Fundamental requirements and test methods for optical radiation safety | Ophthalmic | ISO |
| TIR 36:2007 | Validation of software for regulated processes | Software/Informatics | AAMI |
| 8536-5 Second edition 2004-02-01 | Infusion equipment for medical use – Part 5:Â Burette infusion sets for single use gravity feed | General Plastic Surgery/General Hospital | ISO |
| 10651-4 First edition 2002-03-01 | Lung ventilators – Part 4: Particular requirements for operator powered resuscitators | Anesthesiology | ISO |
| M53-A (Replaces M53-P) | Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline | InVitro Diagnostics | CLSI |
| 11073-10407 First edition 2010-05-01 | Health informatics – Personal health device communication – Part 10407: Device Specialization – Blood pressure monitor | Software/Informatics | IEEE ISO |
| /TS 62443-1-1 Edition 1.0 2009-07 | Industrial communication networks – Network and system security – Part 1-1: Terminology concepts and models | Software/Informatics | IEC |
| /TR 62443-3-1 Edition 1.0 2009-07 | Industrial communication networks – Network and system security – Part 3-1: Security technologies for industrial automation and control systems | Software/Informatics | IEC |
| F138-13 | Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) | Materials | ASTM |
| 14801 Second edition 2007-11-15 | Dentistry-Implants-Dynamic fatigue test for endosseous dental implants | Dental/ENT | ISO |
| 6876 Third edition 2012-06-01 | Dentistry — Root canal sealing materials | Dental/ENT | ISO |
| F2695-12 | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications | Materials | ASTM |
| F2820-12 | Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications | Materials | ASTM |
| F2887-17 | Standard Specification for Total Elbow Prostheses | Orthopedic | ASTM |
| Specification No. 38 2000 (R2015) | Metal-Ceramic Dental Restorative Systems | Dental/ENT | ANSI ADA |
| 7207-1 Third edition 2007-02-01 | Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification definitions and designation of dimensions | Orthopedic | ISO |
| F1820-13 | Standard Test Method for Determining the Forces for Disassembly of Modular Acetublar Devices | Orthopedic | ASTM |
| F88/F88M-15 | Standard Test Method for Seal Strength of Flexible Barrier Materials | Sterility | ASTM |
| 18189 First edition 2016-06-01 | Ophthalmic optics – Contact lenses and contact lens care products – Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions | Ophthalmic | ISO |
| 14243-2 Third edition 2016-09-01 | Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement | Orthopedic | ISO |
| 7207-2 Second edition 2011-07-01 | Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal ceramic and plastics materials [Including AMENDMENT 1 (2016)] | Orthopedic | ISO |
| F2605-16 | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) | Tissue Engineering | ASTM |
| F1377-13 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) | Materials | ASTM |
| 80369-6 First Edition 2016-03-15 | Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications. | General I (QS/RM) | ISO |
| F2027-16 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products | Tissue Engineering | ASTM |
| F1582-98 (Reapproved 2016) | Standard Terminology Relating to Spinal Implants | Orthopedic | ASTM |
| F116-12 (Reapproved 2016) | Standard Specification for Medical Screwdriver Bits | Orthopedic | ASTM |
| F1058-16 | Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire Strip and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) | Materials | ASTM |
| 60601-2-17 Edition 3.0 2013-11 | Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment | Radiology | IEC |
| 61689 Edition 3.0 2013-02 | Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz | Radiology | IEC |
| D7907-14 (Reapproved 2019) | Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves | General Plastic Surgery/General Hospital | ASTM |
| 15309 First edition 2013-12-01 | Implants for surgery – Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices | Materials | ISO |
| F1357 -14 (Reapproved 2019) | Standard Specification for Articulating Total Wrist Implants | Orthopedic | ASTM |
| Std 3333.2.1-2015 | IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling | Radiology | IEEE |
| SNOMED-CT RF2 Release 2015 | Systematized Nomenclature of Medicine – Clinical Terms | Software/Informatics | IHTSDO |
| 60086-5 Edition 4.0 2016-07 | Primary batteries – Part 5: Safety of batteries with aqueous electrolyte | General II (ES/EMC) | IEC |
| 62485-2 Edition 1.0 2010-06 | Safety requirements for secondary batteries and battery installations – Part 2: Stationary batteries. | General II (ES/EMC) | IEC |
| F3186-17 | Standard Specification for Adult Portable Bed Rails and Related Products | General Plastic Surgery/General Hospital | ASTM |
| F3206-17 | Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies | Tissue Engineering | ASTM |
| 7199 Third edition 2016-11-15 | Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators). | Cardiovascular | ISO |
| Specification No. 88 (Reaffirmed 2012) | Dental Brazing Alloys | Dental/ENT | ANSI ADA |
| F1169-13 | Standard Consumer Safety Specification for Full-Size Baby Cribs | General Plastic Surgery/General Hospital | ASTM |
| 29942 First edition 2011-07-01 | Prophylatic dams — Requirements and test methods | ObGyn/Gastroenterology/Urology | ISO |
| 2859-1 Second edition 1999-11-15 | Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001) Amendment 1 (2011)] | General I (QS/RM) | ISO |
| MS 10-2010 | Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging | Radiology | NEMA |
| 80601-2-35 Edition 2.1 2016-04 | CONSOLIDATED VERSION Medical electrical equipment-Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)] | General Plastic Surgery/General Hospital | IEC |
| Version 2.48 | Logical Observation Identifiers Names and Codes (LOINC) | Software/Informatics | RII |
| F2051-00 (Reapproved 2014) | Standard Specification for Implantable Saline Filled Breast Prosthesis | General Plastic Surgery/General Hospital | ASTM |
| M56-A | Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline | InVitro Diagnostics | CLSI |
| 7176-10 Second edition 2008-11-01 | Wheelchairs – Part 10:Â Determination of obstacle-climbing ability of electrically powered wheelchairs | Physical Medicine | ISO |
| Z80.11-2012 (R2017) | American National Standard for Ophthalmics – Laser Systems for Corneal Reshaping | Ophthalmic | ANSI |
| 29022 First edition 2013-06-01 | Dentistry – Adhesive – Notched-edge sheer bond strength test | Dental/ENT | ISO |
| Z80.30-2018 | American National Standard for Ophthalmics – Toric Intraocular Lenses | Ophthalmic | ANSI |
| F2996-13 | Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems | Orthopedic | ASTM |
| F1713-08 (Reapproved 2013) | Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130) | Materials | ASTM |
| F1091-12 | Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) | Materials | ASTM |
| F2097-16 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products | Sterility | ASTM |
| 7153-1 Second edition 1991-04-01 | Surgical instruments — Metallic materials — Part 1: Stainless steel [Including: Amendment 1 (1999)] | Materials | ISO |
| F2052-15 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | Materials | ASTM |
| 60601-2-8 Edition 2.1 b:2015 | Medical electrical equipment – Part 2-8:Â Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV | Radiology | IEC |
| F2217/F2217M- (Reapproved 2018) | Standard Practice for Coating/Adhesive Weight Determination | Sterility | ASTM |
| F1140/F1140M-13 | Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages | Sterility | ASTM |
| F2250-13 (Reapproved 2018) | Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials | Sterility | ASTM |
| MS 2-2008 (R2014) | Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images | Radiology | NEMA |
| 2054 2nd Edition | Household and Commercial Batteries | General II (ES/EMC) | UL |
| 7176-11 Second edition 2012-12-01 | Wheelchairs – Part 11: Test dummies | Physical Medicine | ISO |
| 15798 Third edition 2013-09-15 15 [including AMENDMENT 1 (2017-05)] | Ophthalmic implants – Ophthalmic viscosurgical devices | Ophthalmic | ISO |
| 7176-16 Second edition 2012-12-01 | Wheelchairs – Part 16:Â Resistance to ignition of postural support devices | Physical Medicine | ISO |
| 7176-3 Third edition 2012-12-15 | Wheelchairs – Part 3:Â Determination of effectiveness of brakes | Physical Medicine | ISO |
| MS 9-2008 (R2014) | Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images | Radiology | NEMA |
| EC53:2013 | ECG trunk cables and patient leadwires | Cardiovascular | ANSI AAMI |
| F2514-08 (Reapproved 2014) | Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial | Cardiovascular | ASTM |
| S3.2-2009 (Reaffirmed 2014) | American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems | Dental/ENT | ANSI |
| 7176-7 First Edition 1998-05-15 | Wheelchairs – Part 7: Measurement of seating and wheel dimensions | Physical Medicine | ISO |
| 7176-22 Second edition 2014-09-01 | Wheelchairs – Part 22: Set-up procedures | Physical Medicine | ISO |
| 8536-8 Second Edition 2015-06-15 | Infusion Equipment for Medical Use – Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus | General Plastic Surgery/General Hospital | ISO |
| 8536-10 Second Edition 2015-06-15 | Infusion Equipment for Medical Use – Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment | General Plastic Surgery/General Hospital | ISO |
| D4169-16 | Standard Practice for Performance Testing of Shipping Containers and Systems | Sterility | ASTM |
| Specification No. 48:2004 (R2015) | Visible Light Curing Units | Dental/ENT | ANSI ADA |
| S3.20-2015 (Revision of ANSI S3.20-1995) | American National Standard Bioacoustical Terminology | Dental/ENT | ANSI ASA |
| ST58:2013/(R)2018 | Chemical sterilization and high-level disinfection in health care facilities | Sterility | ANSI AAMI |
| Specification No. 58-2010 (R2015) | Root Canal Files Type H (Hedstrom) | Dental/ENT | ANSI ADA |
| 7176-9 Third edition 2009-11-15 | Wheelchairs – Part 9:Â Climatic tests for electric wheelchairs | Physical Medicine | ISO |
| 11670 Second edition 2003-04-01 | Lasers and laser-related equipment – Test methods for laser beam parameters – Beam positional stability [Including: Technical Corrigendum 1 (2004)] | Radiology | ISO |
| 62127-03 Edition 1.1 2013-05 | Ultrasonics — Hydrophones — Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz | Radiology | IEC |
| 12609-1 First edition 2013-07-15 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products | Radiology | ISO |
| EP05-A3 | Evaluation of Precision of Quantitative Measurement Procedures;Â Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| EP14-A3 | Evaluation of Commutability of Processed Samples; Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| 60601-2-22 Edition 3.1 2012-10 | Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment | Radiology | IEC |
| F2392-04 (Reapproved 2015) | Standard Test Method for Burst Strength of Surgical Sealants | Materials | ASTM |
| F1781-15 | Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants | Orthopedic | ASTM |
| F1926/F1926M-14 | Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules Fabricated Forms and Coatings | Materials | ASTM |
| F2338-09 (Reapproved 2013) | Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method | Sterility | ASTM |
| S3.7-1995 (Reaffirmed 2008) | American National Standard Method for Coupler Calibration of Earphones | Dental/ENT | ANSI |
| F3161-16 | Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions. | Orthopedic | ASTM |
| 7176-15 First edition 1996-11-15 | Wheelchairs – Part 15:Â Requirements for information disclosure documentation and labeling | Physical Medicine | ISO |
| 10555-4 Second edition 2013-06-15 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters | General Plastic Surgery/General Hospital | ISO |
| F2989-13 | Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications | Materials | ASTM |
| 12005 Second edition 2003-04-01 | Lasers and laser-related equipment – Test methods for laser beam parameters – Polarization | Radiology | ISO |
| 15367-1 First edition 2003-09-15 | Lasers and laser-related equipment – Test methods for determination of the shape of a laser beam wavefront – Part 1: Terminology and fundamental aspects | Radiology | ISO |
| 11146-1 First edition 2005-01-15 | Lasers and laser-related equipment – Test methods for laser beam widths divergence angles and beam propagation ratios – Part 1: Stigmatic and simple astigmatic beams | Radiology | ISO |
| TR 22979 First edition 2006-02-01 | Ophthalmic implants – Intraocular lenses – Guidance on assessment of the need for clinical investigation of intraocular lens design modifications | Ophthalmic | ISO |
| M06-A2 | Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard – Second Edition | InVitro Diagnostics | CLSI |
| M28-A2 (Replaces M28-A) | Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| AUTO3-A2 | Laboratory Automation:Â Communications with Automated Clinical Laboratory Systems Instruments Devices and Information Systems; Approved Standard | Software/Informatics | CLSI |
| F921-10 (Reapproved 2018) | Standard Terminology Relating to Hemostatic Forceps | General Plastic Surgery/General Hospital | ASTM |
| SW87:2012 | Application of quality management system concepts to medical device data systems | Software/Informatics | ANSI AAMI |
| TIR 45:2012 | Guidance on the use of AGILE practices in the development of medical device software | Software/Informatics | AAMI |
| 6.2.02:2006 | Official Method 991.47 Testing Disinfectants Against Salmonella choleraesuis Hard Surface Carrier Test Method | Sterility | AOAC |
| 6.2.03:2006 | Official Method 991.48 Testing Disinfectants Against Staphylococcus aureus Hard Surface Carrier Test Method | Sterility | AOAC |
| 6.2.05:2006 | Official Method 991.49 Testing Disinfectants Against Pseudomonas aeruginosaHard Surface Carrier Test Method | Sterility | AOAC |
| 6.3.02:2006 | Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes | Sterility | AOAC |
| 10651-5 First edition 2006-02-01 | Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators | Anesthesiology | ISO |
| 7198:2016 Second edition | Cardiovascular implants and extracorporeal systems–Vascular prostheses–Tubular vascular grafts and vascular patches | Cardiovascular | ANSI AAMI ISO |
| 7176-5 Second edition 2008-06-01 | Wheelchairs – Part 5:Â Determination of overall dimensions mass and manoeuvring space | Physical Medicine | ISO |
| BF7:2012 | Blood transfusion microfilters | General Plastic Surgery/General Hospital | ANSI AAMI |
| D6978-05 (Reapproved 2019) | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | General Plastic Surgery/General Hospital | ASTM |
| 11608-4 First edtion 2006-03-15 | Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors | General Plastic Surgery/General Hospital | ISO |
| 8536-7 Third edition 2009-01-15 | Infusion equipment for medical use – Part 7: Caps made of aluminum-plastics combinations for infusion bottles | General Plastic Surgery/General Hospital | ISO |
| F2710-13 | Standard Consumer Safety Performance Specification for Commerical Cribs | General Plastic Surgery/General Hospital | ASTM |
| NBS01-A6 (Replaces LA04-A5) | Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard – Sixth Edition | InVitro Diagnostics | CLSI |
| EP28-A3c (Formerly C28-A3c) | Defining Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| QMS06-A3 (Formerly GP22-A3) | Quality Management System: Continual Improvement; Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| 51275 Third edition 2013-06-01 | Practice for use of a radiochromic film dosimetry system | Sterility | ASTM ISO |
| F2009-00 (Reapproved 2011) | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses | Orthopedic | ASTM |
| EP06-A (Replaces EP6-P2) | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline | InVitro Diagnostics | CLSI |
| 14644-8 Second edition 2013-02-15 | Cleanrooms and associated controlled environments – Part 8: Classification of air cleanliness by chemical concentration (ACC) | Sterility | ISO |
| 14644-9 First edition 2012-08-15 | Cleanrooms and associated controlled environments – Part 9: Classification of surface cleanliness by particle concentration | Sterility | ISO |
| 61168:1993 | Radiotherapy simulators – Functional performance characteristics | Radiology | IEC |
| MS 11-2010 | Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging | Radiology | NEMA |
| D882-12 | Standard Test Methods for Tensile Properties of Thin Plastic Sheeting | Ophthalmic | ASTM |
| 9584 First edition 1993-10-15 | Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants | Materials | ISO |
| F813-07 (Reapproved 2012) | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices | Biocompatibility | ASTM |
| 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION | Ultrasonics – Pulse-echo scanners – Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response | Radiology | IEC |
| TS 62462 Edition 2.0 2017-07 | Ultrasonics – Output test – Guide for the maintenance of ultrasound physiotherapy systems | Radiology | IEC |
| 14644-7 First edition 2004-10-01 | Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods gloveboxes isolators and mini-environments) | Sterility | ISO |
| F2095-07 (Reapproved 2013) | Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates | Sterility | ASTM |
| F2251-13 (Reapproved 2018) | Standard Test Method for Thickness Measurement of Flexible Packaging Material | Sterility | ASTM |
| ST24:1999/(R)2018 | Automatic general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities 3ed. | Sterility | ANSI AAMI |
| 62563-1 Edition 1.1 | Medical electrical equipment – Medical image display systems – Part 1: Evaluation methods | Radiology | IEC |
| S3.39:1987 (Reaffirmed 2012) | American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) | Dental/ENT | ANSI |
| F2477-07 (Reapproved 2013) | Standard Test Methods for in vitro Pulsatile Durability | Cardiovascular | ASTM |
| F620-11 (Reapproved 2015) | Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition | Materials | ASTM |
| F629-15 | Standard Practice for Radiography of Cast Metallic Surgical Implants | Materials | ASTM |
| F2224-09 (Reapproved 2014) | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants | Materials | ASTM |
| F2172-02 (Reapproved 2011) | Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers | General Plastic Surgery/General Hospital | ASTM |
| 10555-5 Second edition 2013-06-15 | Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters | General Plastic Surgery/General Hospital | ISO |
| 14644-10 First edition 2013-03-01 | Cleanrooms and associated controlled environments – Part 10: Classification of surface cleanliness by chemical concentration | Sterility | ISO |
| 10535 Second edition 2006-12-15 | Hoists for the transfer of disabled persons – Requirements and test methods | General Plastic Surgery/General Hospital | ISO |
| F2391-05 (Reapproved 2016) | Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas | Sterility | ASTM |
| F2252/F2252M-13 (Reapproved 2018) | Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape | Sterility | ASTM |
| Z80.36-2016 | American National Standard for Ophthalmics – Light Hazard Protection for Ophthalmic Instruments | Ophthalmic | ANSI |
| TIR69: 2017 | Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. | General II (ES/EMC) | AAMI |
| 60086-4 Edition 4.0 2014-09 | Primary batteries – Part 4: Safety of lithium batteries | General II (ES/EMC) | IEC |
| 5838-2 First edition 1991-01-15 | Implants for surgery — Skeletal pins and wires — Part 2: Steinmann skeletal pins — Dimensions | Orthopedic | ISO |
| 5838-3 First edition 1993-09-15 | Implants for surgery — Skeletal pins and wires — Part 3: Kirschner skeletal wires | Orthopedic | ISO |
| 13402 First edition 1995-08-01 | Surgical and dental hand instruments — Determination of resistance against autoclaving corrosion and thermal exposure | Orthopedic | ISO |
| 16037 First edition 2002-05-15 (Amendment 1 2011-02-15) | Rubber condoms for clinical trials – Measurement of physical properties [Including: Amendment (2011)] | ObGyn/Gastroenterology/Urology | ISO |
| 61674 Edition 2.0 2012-11 | Medical electrical equipment — Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging | Radiology | IEC |
| EP32-R (Formerly X05-R) | Metrological Traceability and Its Implementation; A Report | InVitro Diagnostics | CLSI |
| H26-A2 | Validation Verification and Quality Assurance of Automated Hematology Analyzers; Proposed Standard – Second Edition | InVitro Diagnostics | CLSI |
| EP12-A2 | User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| F2214-16 | Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) | Materials | ASTM |
| C60-A | Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline | InVitro Diagnostics | CLSI |
| GP42-A6 (Formerly H04-A6) | Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard — Sixth Edition | InVitro Diagnostics | CLSI |
| GP39-A6 (Formerly H01-A6) | Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition | InVitro Diagnostics | CLSI |
| 5832-4 Third edition 2014-09-15 | Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy | Materials | ISO |
| 5832-1 Fifth edition 2016-07-15 | Implants for surgery – Metallic materials – Part 1: Wrought stainless steel | Materials | ISO |
| F2625-10 (Reapproved 2016) | Standard Test Method for Measurement of Enthalpy of Fusion Percent Crystallinity and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry | Materials | ASTM |
| 14698-2 First edition 2003-09-15 | Cleanrooms and Associated Controlled Environments – Biocontamination Control – Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] | Sterility | ISO |
| 6.2.04:2013 | Official Method 955.15 Testing Disinfectants Against Staphylococcus aureusUse-Dilution Method | Sterility | AOAC |
| 6.3.05:2013 | Official Method 966.04 Sporicidal Activity of Disinfectants Method I | Sterility | AOAC |
| 6.3.06:2012 | Official Method 965.12 Tuberculocidal Activity of Disinfectants | Sterility | AOAC |
| F2203-13 (Reapproved 2018) | Standard Test Method for Linear Measurement Using Precision Steel Rule | Sterility | ASTM |
| F1670/F1670M-17 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood | General Plastic Surgery/General Hospital | ASTM |
| 13175-3 First edition 2012-10-01 | Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes | Materials | ISO |
| 18369-1 Second edition 2017-08 | Ophthalmic optics – Contact lenses – Part 1: Vocabulary classification system and recommendations for labelling specifications | Ophthalmic | ISO |
| POCT14-A (Formerly H49-A) | Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline | InVitro Diagnostics | CLSI |
| GP43-A4 (Formerly H11-A4) | Procedures for the Collection of Arterial Blood Specimens; Approved Standard — Fourth Edition | InVitro Diagnostics | CLSI |
| V-5:2008 (Reaffirmed 2013) | Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) | Anesthesiology | CGA |
| N43.6-2007 (R2013) | Sealed Radioactive Sources – Classification | Radiology | ANSI HPS |
| AUTO13-A2 (Formerly GP19-A2) | Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation Operation and Monitoring; Approved Guideline – Second Edition | Software/Informatics | CLSI |
| F2761-09 (2013) | Medical Devices and Medical Systems – Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) – Part 1: General requirements and conceptual model | Software/Informatics | ASTM |
| F2227-13 | Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method | Sterility | ASTM |
| F1672-14 (Reapproved 2019) | Standard Specification for Resurfacing Patellar Prosthesis | Orthopedic | ASTM |
| Std 11073-10424-2014 | Health informatics – Personal health device communication Part 10424: Device Specialization – Sleep Apnoea Breathing Therapy Equipment (SABTE) | Software/Informatics | IEEE |
| ST8:2013/(R)2018 | Hospital steam sterilizers | Sterility | ANSI AAMI |
| TS 80004-6 First edition 2013-11-01 | Nanotechnologies – Vocabulary – Part 6: Nano-object characterization | Nanotechnology | ISO |
| 4311 First edition 1979-06-01 | Anionic and non-ionic surface active agents – Determination of critical micellization concentration – Method by measuring surface tension with a plate stirrup or ring | Ophthalmic | ISO |
| F2582-14 | Standard Test Method for Impingement of Acetabular Prostheses | Orthopedic | ASTM |
| 7176-25 First edition 2013-07-15 | Wheelchairs – Part 25: Batteries and chargers for powered wheelchairs | Physical Medicine | ISO |
| 11073-10102 First edition 2014-03-01 | Health informatics – Point-of-care medical device communication – Part 10102: Nomenclature – Annotated ECG | Software/Informatics | IEEE ISO |
| 30111 First edition 2013-11-01 | Information technology – Security techniques – Vulnerability handling processes | Software/Informatics | IEC ISO |
| ST91:2015 | Flexible and semi-rigid endoscope processing in health care facilities | Sterility | ANSI AAMI |
| F1078-10 (Reapproved 2018) | Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades | General Plastic Surgery/General Hospital | ASTM |
| F1992 -99 (Reapproved 2007) | Standard Practice for Reprocessing of Reusable Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes | ObGyn/Gastroenterology/Urology | ASTM |
| S3.6-2010 (Revision of ANSI S3.6-2004) | American National Standard Specification for Audiometers | Dental/ENT | ANSI |
| 60601-2-29 Edition 3.0 2008-06 | Medical electrical equipment – Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators | Radiology | IEC |
| AUTO7-A | Laboratory Automation: Data Content for Specimen Identification; Approved Standard | Software/Informatics | CLSI |
| S3.21-2004 (Reaffirmed 2009) | American National Standard Methods for Manual Pure-Tone Threshold Audiometry | Dental/ENT | ANSI |
| ID54:1996/(R)2012 | Enteral feeding set adapters and connectors | ObGyn/Gastroenterology/Urology | ANSI AAMI |
| H7-A3 | Procedure for Determining Packed Cell Volume by the Microhematocrit Method – Second Edition; Approved Standard – Third Edition. | InVitro Diagnostics | CLSI |
| 99:2005 | Standard for Health Care Facilities Chapter 20 – Hyperbaric Facilities | Anesthesiology | NFPA |
| 9236-1 Second edition 2004-02-01 | Photography – Sensitometry of screen/film systems for medical radiography – Part 1: Determination of sensitometric curve shape speed and average gradient | Radiology | ISO |
| 4090 Third eidition 2001-08-15 | Photography – Medical radiographic cassette/screens/films and hard-copy imaging films – Dimensions and specifications | Radiology | ISO |
| 5799 Second edition 1991-08-01 | Photography — Direct-exposing medical and dental radiographic film/process systems — Determination of ISO speed and ISO average gradient | Radiology | ISO |
| 13696:2002 | Optics and optical instruments — Test methods for radiation scattered by optical components | Radiology | ISO |
| N42.13-2004 | Calibration and Usage of “Dose Calibrator” Ionization Chambers for the Assay of Radionuclides | Radiology | IEEE |
| 5832-6:1997 | Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy | Materials | ISO |
| 6874 Third edition 2015-09-01 | Dentistry – Polymer-based pit and fissure sealants | Dental/ENT | ISO |
| 61846 First edition 1998-04 | Ultrasonics – Pressure pulse lithotripters – Characteristics of fields | ObGyn/Gastroenterology/Urology | IEC |
| 14698-1:2003 | Cleanrooms and Associated Controlled Environments – Biocontamination Control – Part 1: General Principles and Methods | Sterility | ISO |
| LIS01-A2 | Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems | Software/Informatics | CLSI |
| I/LA21-A2 | Clinical Evaluation of Immunoassays; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| GP28-A (Replaces GP28-P) | Microwave Device Use in the Histology Laboratory; Approved Guideline | InVitro Diagnostics | CLSI |
| C44-A (Replaces C44-P) | Harmonization of Glycohemoglobin Measurements; Approved Guideline | InVitro Diagnostics | CLSI |
| I/LA30-A (Replaces I/LA30-P) | Immunoassay Interference by Endogenous Antibodies; Approved Guideline. | InVitro Diagnostics | CLSI |
| POCT1-A2 | Point-of-Care Connectivity | Software/Informatics | CLSI |
| LIS02-A2 | Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition | Software/Informatics | CLSI |
| LIS04-A | Standard Guide for Documentation of Clinical Laboratory Computer Systems | Software/Informatics | CLSI |
| LIS05-A | Standand Specification for Transferring Clinical Observations Between Independent Computer Systems | Software/Informatics | CLSI |
| LIS06-A | Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems | Software/Informatics | CLSI |
| LIS07-A | Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory | Software/Informatics | CLSI |
| LIS08-A | Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems | Software/Informatics | CLSI |
| LIS09-A | Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures | Software/Informatics | CLSI |
| H47-A2 | One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| GP16-A3 (Replaces GP16-A2) | Urinalysis; Approved Guideline – Third Edition | InVitro Diagnostics | CLSI |
| F2914-12 | Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices | Cardiovascular | ASTM |
| 11040-5 Third edition 2012-02-15 | Prefilled syringes – Part 5: Plunger stoppers for injectables | General Plastic Surgery/General Hospital | ISO |
| M15-A (Replaces M15-T) | Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline | InVitro Diagnostics | CLSI |
| 62471 First edition 2006-07 | Photobiological safety of lamps and lamp systems | Radiology | IEC |
| 60601-2-23 Edition 3.0 2011-02 | Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment | Anesthesiology | IEC |
| 10936-2 Second edition 2010-01-15 | Optics and photonics – Operation microscopes – Part 2: Light hazard from operation microscopes used in ocular surgery | Ophthalmic | ISO |
| M35-A2 (Replaces M35-A) | Abbreviated Identification of Bacteria and Yeast; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| H43-A2 | Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| F2759-11 | Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices | Materials | ASTM |
| 18192-2 First edition 2010-06-15 | Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 2: Nucleus replacements | Orthopedic | ISO |
| S3.44-1996 Reaffirmed by ANSI on 27 April 2006 | American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment | Dental/ENT | ANSI |
| TS 14101 First edition 2012-11-01 | Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method | Nanotechnology | ISO |
| 26825 First edition 2008-08-15 | Anaesthetic and respiratory equipment – User-applied labels for syringes containing drugs used during anaesthesia – Colours design and performance | Anesthesiology | ISO |
| Std 2010-2012 | Recommended Practice for Neurofeedback Systems | Neurology | IEEE |
| 11979-3 Third edition 2012-12-01 | Ophthalmic implants – Intraocular lenses – Part 3:Â Mechanical properties and test methods | Ophthalmic | ISO |
| 11979-1 Third edition 2012-09-15 | Ophthalmic implants – Intraocular lenses – Part 1:Â Vocabulary | Ophthalmic | ISO |
| 14644-3 First edition 2005-12-15 | Cleanrooms and associated controlled environments – Part 3: Test methods | Sterility | ISO |
| 60601-2-5: Edition 3.0 2009-07 | Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment | Radiology | IEC |
| 62133 Edition 2.0 2012-12 | Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications [Including: Corrigendum 1 (2013)] | General II (ES/EMC) | IEC |
| D790-10 | Standard Test Methods for Flexure Properties of Unreinforced Plastics and Electrical Insulating Materials | Ophthalmic | ASTM |
| F2665-09 (Reapproved 2014) | Standard Specification for Total Ankle Replacement Prosthesis | Orthopedic | ASTM |
| 10012 First edition 2003-01-15 | Measurement management systems – Requirements for measurement processes and measuring equipment | General I (QS/RM) | ISO |
| I/LA23-A (Replaces I/LA23-P) | Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme Fluorescence and Luminescence Immunoassays; Approved Guideline | InVitro Diagnostics | CLSI |
| 60806 First edition 1984-01 | Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis | Radiology | IEC |
| 10939 Second edition 2007-02-01 | Ophthalmic instruments – Slit-lamp microscopes | Ophthalmic | ISO |
| 10942 Second edition 2006-06-01 | Ophthalmic instruments – Direct ophthalmoscopes | Ophthalmic | ISO |
| 12865 Second edition 2006-07-01 | Ophthalmic instruments – Retinoscopes | Ophthalmic | ISO |
| 14880-2:2006 | Optics and photonics — Microlens arrays — Part 2: Test methods for wavefront aberrations | Radiology | ISO |
| 14880-3:2006 | Optics and photonics — Microlens arrays — Part 3: Test methods for optical properties other than wavefront aberrations | Radiology | ISO |
| M34-A (Replaces M24-P) | Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. | InVitro Diagnostics | CLSI |
| M36-A | Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. | InVitro Diagnostics | CLSI |
| M41-A | Viral Culture; Approved Guideline. | InVitro Diagnostics | CLSI |
| F2132 -01 (Reapproved 2008)e1 | Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps | General Plastic Surgery/General Hospital | ASTM |
| M47-A (Replaces M47-P) | Principles and Procedures for Blood Cultures; Approved Guideline | InVitro Diagnostics | CLSI |
| M50-A (Replaces M50-P) | Quality Control for Commercial Microbial Identification Systems; Approved Guideline | InVitro Diagnostics | CLSI |
| MM13-A (Replaces MM13-P) | Collection Transport Preparation and Storage of Specimens for Molecular Methods; Approved Guideline | InVitro Diagnostics | CLSI |
| MM18-A (Replaces MM18-P) | Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline | InVitro Diagnostics | CLSI |
| H15-A3 (Replaces H15-A2) | Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition | InVitro Diagnostics | CLSI |
| H51-A | Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline. | InVitro Diagnostics | CLSI |
| POCT05-A (Replaces POCT05-P) | Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline. | InVitro Diagnostics | CLSI |
| 62494-1 Edition 1.0 (2008-08) | Medical electrical equipment – Exposure index of digital X-ray imaging systems – Part 1: Definitions and requirements for general radiography | Radiology | IEC |
| C34-A3 (Replaces C34-A2) | Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline – Third Edition. | InVitro Diagnostics | CLSI |
| 62083 Edition 2.0 2009-09 | Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems | Radiology | IEC |
| EP18-A2 | Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| 61223-3-4 First edition 2000-03 | Evaluation and routine testing in medical imaging departments – Part 3-4: Acceptance tests – Imaging performance of dental X-ray | Radiology | IEC |
| 11146-2 First edition 2005-02-15 | Lasers and laser-related equipment – Test methods for laser beam widths divergence angles and beam propagation ratios – Part 2: General astigmatic beams | Radiology | ISO |
| 10943 Third edition 2011-08-15 | Ophthalmic instruments – Indirect ophthalmoscopes | Ophthalmic | ISO |
| 15004-1 First edition 2006-06-01 | Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments | Ophthalmic | ISO |
| 17526 First edition 2003-06-15 | Optics and optical instruments – Lasers and laser-related equipment – Lifetime of lasers | Radiology | ISO |
| 21254-2 First edition 2011-07-15 | Lasers and laser-related equipment – Test methods for laser-induced damage threshold – Part 2: Threshold determination | Radiology | ISO |
| 21254-1 First edition 2011-07-15 | Lasers and laser-related equipment – Test methods for laser-induced damage threshold – Part 1: Definitions and general principles | Radiology | ISO |
| 8536-2 Third edition 2010-03-15 | Infusion equipment for medical use – Part 2: Closures for infusion bottles | General Plastic Surgery/General Hospital | ISO |
| F2096-11 | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | Sterility | ASTM |
| F2528-06 (Reapproved 2014) | Standard Test Methods for Enteral Feeding Devices with a Retention Balloon | ObGyn/Gastroenterology/Urology | ASTM |
| V-7.1:2011 | Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases | Anesthesiology | CGA |
| ST65:2008/(R)2018 | Processing of reusable surgical textiles for use in health care facilities | Sterility | ANSI AAMI |
| F2451-05 (Reapproved 2010) | Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage | Tissue Engineering | ASTM |
| F2312-11 | Standard Terminology Relating to Tissue Engineered Medical Products | Tissue Engineering | ASTM |
| E1112-00 (Reapproved 2011) | Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature | General Plastic Surgery/General Hospital | ASTM |
| H20-A2 (Replaces H20-A) | Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard – Second Edition | InVitro Diagnostics | CLSI |
| 9394 Third edition 2012-10-01 | Ophthalmic optics – Contact lenses and contact lens care products – Determination of biocompatibility by ocular study with rabbit eyes | Ophthalmic | ISO |
| 11318:2002 | Cardiac Defibrillators — Connector assembly DF-1 for implantable defibrillators – Dimensions and test requirements. | Cardiovascular | ISO |
| 7176-21 Second edition 2009-04-01 | Wheelchairs – Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters and battery chargers | Physical Medicine | ISO |
| 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | Radiology | IEC |
| F961-14 | Standard Specification for 35Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) | Materials | ASTM |
| F2971-13 | Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing | Materials | ASTM |
| 8828 Second edition 2014-11-15 | Implants for surgery — Guidance on care and handling of orthopaedic implants | Orthopedic | ISO |
| 11073-10408 First edition 2010-05-01 | Health informatics – Point-of-care medical device communication – Part 10408: Device specialization – Thermometer | Software/Informatics | IEEE ISO |
| 11073-10415 First edition 2010-05-01 | Health informatics – Point-of-care medical device communication – Part 10415: Device specialization – Weighing scale | Software/Informatics | IEEE ISO |
| 11073-10404 First edition 2010-05-01 | Health informatics – Personal health device communication – Part 10404: Device specialization – Pulse oximeter | Software/Informatics | IEEE ISO |
| 9917-1 Second edition 2007-10-01 | Dentistry –Â Water-based cements – Part 1: Powder/liquid acid-base cements | Dental/ENT | ISO |
| 8536-3 Third edition 2009-06-01 | Infusion equipment for medical use – Part 3:Â Aluminum caps for infusion bottles | General Plastic Surgery/General Hospital | ISO |
| 11608-2 Second edition 2012-04-01 | Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles | General Plastic Surgery/General Hospital | ISO |
| 8536-1 Fourth edition 2011-09-01 | Infusion equipment for medical use – Part 1:Â Infusion glass bottles | General Plastic Surgery/General Hospital | ISO |
| 6877 Second edition 2006-04-01 | Dentistry – Root-canal obturating points | Dental/ENT | ISO |
| 14630 Fourth edition 2012-12-01 | Non-active surgical implants — General requirements | Orthopedic | ISO |
| PVHO-1-2007 | Safety Standard for Pressure Vessels for Human Occupancy | Anesthesiology | ASME |
| EP24-A2 (Replaces GP 10-A) | Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| C56-A | Hemolysis Icterus and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline | InVitro Diagnostics | CLSI |
| 11979-7 Second edition 2006-05-01 | Ophthalmic implants – Intraocular lenses – Part 7:Â Clinical investigations [Including: Amendment 1 (2012)] | Ophthalmic | ISO |
| /TIR 80001-2-6:2014 | Application of risk management for IT networks incorporating medical devices – Part 2-6: Application guidance – Guidance for responsibility agreements | Software/Informatics | AAMI ISO |
| TIR57:2016 | Principles for medical device security – Risk management. | Software/Informatics | AAMI |
| 11073-10103 First edition 2014-03-01 | Health informatics – Point-of-care medical device communication – Part 10103: Nomenclature – Implantable device cardiac | Software/Informatics | IEEE ISO |
| 14879-1 First edition 2000-06-01 | Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays | Orthopedic | ISO |
| C59-A | Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline | InVitro Diagnostics | CLSI |
| 14644-4 First edition 2001-04-01 | Cleanrooms and associated controlled environments – Part 4: Design construction and start-up | Sterility | ISO |
| 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION | Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment | Radiology | IEC |
| 60417:2002 DB | Graphical symbols for use on equipment | General I (QS/RM) | IEC |
| F1223-14 | Standard Test Method for Determination of Total Knee Replacement Constraint | Orthopedic | ASTM |
| 11979-9 First edition 2006-09-01 | Ophthalmic implants – Intraocular lenses – Part 9: Multifocal intraocular lenses [Including: Amendment 1 (2014)] | Ophthalmic | ISO |
| 11979-10 First edition 2006-08-15 | Ophthalmic implants – Intraocular lenses – Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)] | Ophthalmic | ISO |
| 14644-2 Second edition 2015-12-15 | Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration | Sterility | ISO |
| 52303 First edition 2015-07-15 | Guide for absorbed-dose mapping in radiation processing facilities | Sterility | ASTM ISO |
| F2791-15 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions | Tissue Engineering | ASTM |
| 3107 Fourth edition 2011-03-01 | Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements | Dental/ENT | ISO |
| 11608-5 First edition 2012-10-01 | Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated function. | General Plastic Surgery/General Hospital | ISO |
| MM21-1st Edition | Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications | InVitro Diagnostics | CLSI |
| 9168 Third edition 2009-07-15 | Dentistry – Hose connectors for air driven dental handpieces | Dental/ENT | ISO |
| M51-A (Replaces M51-P) | Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline | InVitro Diagnostics | CLSI |
| F1350-15 | Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) | Materials | ASTM |
| 14644-6 First edition 2007-07-15 | Cleanrooms and associated controlled environments – Part 6: Vocabulary | Sterility | ISO |
| F3127-16 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices | Materials | ASTM |
| 17296-2 First edition 2015-01-15 | Additive manufacturing – General principles – Part 2: Overview of process categories and feedstock | Materials | ISO |
| EP21 2nd Edition (Replaces EP21-A) | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures | InVitro Diagnostics | CLSI |
| C24 4th Edition (Replaces C24-A3) | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions | InVitro Diagnostics | CLSI |
| F2603-06 (Reapproved 2012) | Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds | Tissue Engineering | ASTM |
| F2259-10 (Reapproved 2012)e1 | Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy | Tissue Engineering | ASTM |
| F90-14 | Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) | Materials | ASTM |
| F1185-03 (Reapproved 2014) | Standard Specification for Composition of Hydroxylapatite for Surgical Implants | Materials | ASTM |
| 7176-28 First edition 2012-10-1 | Wheelchairs Part 28: Requirements and test methods for stairclimbing devices | Physical Medicine | ISO |
| 11554 Fourth edition 2017-07 | Optics and photonics – Lasers and laser-related equipment – Test methods for laser beam power energy and temporal characteristics | Radiology | ISO |
| F2345-03 (Reapproved 2013) | Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads | Orthopedic | ASTM |
| 7176-13 First edition 1989-08-01 | Wheelchairs – Part 13: Determination of coefficient of friction of test surfaces | Physical Medicine | ISO |
| /TS 16775 First edition 2014-05-15 | Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2 | Sterility | ISO |
| AUTO11-A2 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard – Second Edition | Software/Informatics | CLSI |
| F451-16 | Standard Specification for Acrylic Bone Cement | Materials | ASTM |
| 7176-4 Third edition 2008-10-01 | Wheelchairs – Part 4:Â Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Physical Medicine | ISO |
| 80601-2-72 First edition 2015-04-11 | Medical electrical equipment – Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients | Anesthesiology | ISO |
| F1108-14 | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) | Materials | ASTM |
| 14408 Third edition 2016-02-15 | Tracheal tubes designed for laser surgery – Requirements for marking and accompanying information | Anesthesiology | ISO |
| 9583 First edition 1993-10-15 | Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants | Materials | ISO |
| 52701 First edition 2013-11-15 | Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing | Sterility | ASTM ISO |
| F2118-14 | Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials | Materials | ASTM |
| 6.2.01:2013 | Official Method 955.14 Testing Disinfectants Against Salmonella choleraesuis Use-Dilution Method | Sterility | AOAC |
| 6.2.06:2013 | Official Method 964.02 Testing Disinfectants Against Pseudomonas aeruginosa Use-Dilution Method | Sterility | AOAC |
| 62220-1-1 Edition 1.0 2015-03 | Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging | Radiology | IEC |
| 51261 Second edition 2013-04-15 | Practice for calibration of routine dosimetry systems for radiation processing | Sterility | ASTM ISO |
| EN 1618:1997 | Catheters other than intravascular catheters – Test methods for common properties | ObGyn/Gastroenterology/Urology | CEN |
| GP44-A4 (Formerly H18-A4) | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition | InVitro Diagnostics | CLSI |
| F2754/F2754M-09 (Reapproved 2013) | Standard Test Method for Measurement of Camber Cast Helix and Direction of Helix of Coiled Wire | Materials | ASTM |
| 14880-4:2006 | Optics and photonics — Microlens arrays — Part 4: Test methods for geometrical properties | Radiology | ISO |
| 61223-3-2 Second eidtion 2007-07 | Evaluation and routine testing in medical imaging departments – Part 3-2: Acceptance tests – Imaging performance of mammographic X-ray equipment | Radiology | IEC |
| 11979-5 Second edition 2006-06-01 | Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility | Ophthalmic | ISO |
| I/LA18-A2 (Replaces I/LA18-A) | Specifications for Immunological Testing for Infectious Diseases; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| C42-A | Erythrocyte Protoporphyrin Testing; Approved Guideline | InVitro Diagnostics | CLSI |
| H44-A2 (Replaces H44-A) | Methods for Reticulocyte Counting (Automated Blood Cell Counters Flow Cytometry and Supravital Dyes); Approved Guideline – Second Edition | InVitro Diagnostics | CLSI |
| I/LA2-A2 (Replaces I/LA2-A) | Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| H21-A5 | Collection Transport and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays | InVitro Diagnostics | CLSI |
| AUTO8-A | Managing and Validating Laboratory Information Systems; Approved Guideline | Software/Informatics | CLSI |
| AUTO10-A | Autoverification of Clinical Laboratory Test Results; Approved Guideline | Software/Informatics | CLSI |
| AUTO9-A | Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard | Software/Informatics | CLSI |
| H42-A2 (Replaces H42-A) | Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline – Second Edition. | InVitro Diagnostics | CLSI |
| XR 22-2006 | Quality Control Manual Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography | Radiology | NEMA |
| AUTO2-A2 | Laboratory Automation:Â Bar Codes for Specimen Container Identification | Software/Informatics | CLSI |
| AUTO1-A | Laboratory Automation:Â Specimen Container/Specimen Carrier; Approved Standard | Software/Informatics | CLSI |
| AUTO4-A | Laboratory Automation: Systems Operational Requirements Characteristics and Information Elements; Approved Standard | Software/Informatics | CLSI |
| 15367-2 First edition 2005-03-15 | Lasers and laser-related equipment – Test methods for determination of the shape of a laser beam wavefront – Part 2: Shack-Hartman sensors | Radiology | ISO |
| 21254-3 First edition 2011-07-15 | Lasers and laser-related equipment – Test methods for laser-induced damage threshold – Part 3: Assurance of laser power (energy) handling capabilities | Radiology | ISO |
| 13697 First edition 2006-05-15 | Optics and photonics — Lasers and laser-related equipment – Test methods for specular reflectance and regular transmittance of optical laser components | Radiology | ISO |
| 24013 First edition 2006-11-15 | Optics and photonics — Lasers and laser-related equipment – Measurement of phase retardation of optical components for polarized laser radiation | Radiology | ISO |
| MS 4-2010 | Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices | Radiology | NEMA |
| 60601-2-57 Edition 1.0 2011-01 | Medical Electrical Equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use | Radiology | IEC |
| AUTO12-A | Specimen Labels: Content and Location Fonts and Label Orientation; Approved Standard | Software/Informatics | CLSI |
| F3295 – 18 | Standard Guide for Impingement Testing of Total Disc Prostheses | Orthopedic | ASTM |
| F2554-18 | Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems | Orthopedic | ASTM |