Medical Equipment Standards

medical-equipment-UL and CE markingHow 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:  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:  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:  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:  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
10993-9  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 –  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)  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 –  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 –  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 –  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:  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:  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)  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:  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:  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 – 13  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 –  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:  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 –  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:  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)  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;  Approved Standard – Second Edition. InVitro Diagnostics CLSI
C31-A2 (Replaces C31-A) Ionized Calcium Determinations:  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:  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:  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:  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:  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:  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:  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:  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:  Resistance to ignition of postural support devices Physical Medicine ISO
7176-3 Third edition 2012-12-15 Wheelchairs – Part 3:  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:  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;  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:  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:  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:  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