CE – High Tech Design Safety

CE Marking Approval and Evaluation

Frequently Asked Questions

How do I get my product CE marked? What is CE marking?

The European Union requires CE marking for all products imported to the union and put into use or trade (for sale) in the European Union. This process is outlined by directives.

The various directives that require conformity are: the low voltage directive, the machinery directive, EMC / EMI directive and other directives. Conformity to CE and CE marking are required. Some types of conformity can be developed by third parties, notified body and certified bodies. All other types of conformity and declaration of conformity are provided by the manufacturer with the support of third parties.

Who can help me get the product CE Marked? How to get my product CE Marked?

We help you do that by operating our Conformity Discovery Process©. In a quick outline, first we determine what your product is. We scope it to the specific and required standards and then provide you a quote.

You send us all the documentation that is required and any missing documentation. We work with you to get it complete, we complete it for you or we outsource it to our documentation team.

What Documentation Do I need for CE marking?

Once your documents and product are complete, we perform literary testing final testing is your report and CE market.

What is the fastest way to CE Mark a product?

The fastest way is to operate a Conformity Discovery Process © and work with us to get it done.

Alternatively, you can try and do it yourself. However, we found most clients get their product rejected by end-users.

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CE Marking

Standard Requirements

EN Standards tend to be standards that were adopted from the IEC, sometimes with minor Variations

EN 60027 Letter symbols to be used in electrical technology

This standard provides you all the details on making your drawings and using the symbols within the drawings as appropriate to match the standards.

IEC EN 60065 Audio, video and similar electronic apparatus – Safety requirements

IEC EN 60068 Environmental Testing

IEC EN 60071 Insulation Co-ordination

IEC EN 60073 Basic Safety principles for man-machine interface, marking and identification

IEC EN 60076 Power transformers

IEC EN 60079 Parts 1–14 Electrical Installations in Hazardous Areas

The standards contain all requirements for explosion protection across all industries. How you get your oil and gas equipment approved…these are the standards. How do I get my pharmaceutical processing equipment approved? these are the standard you would use to get there. How do I get my CBD, THC, Marijuana processing facility up to the code such that it will not blow up or catch fire and I can open it after inspection…work with us and we can get that done quickly and reasonably for you. These are the standards that apply. We just completed several hazardous locations projects with great success before the end users.

IEC EN 60085 Electrical insulation

IEC EN 60086 Primary batteries

IEC EN 60204 Safety of machinery – Electrical equipment of machines

How to get IEC60204 for my equipment? IEC60204 is now pretty much harmonized with the USA standard, NFPA seventy-nine NFPA 79. We can help you get approval for both CE marking under IEC 60204 and NFPA 79 at the same time. That way your equipment is globally conforming. Key issues for NFPA seventy-nine is proper disconnecting means, proper over-current protection. Proper circuit breaker installation, and proper grounding.

IEC EN 60298 high voltage switchgear in metallic enclosure

IEC EN 60335 Safety of electrical household appliances

This is a critical standard for your household appliance approvals. How do I get my appliance approved for CE marking? You would use this standard and our support to get your test completed.

IEC EN 60397 Test methods for batch furnaces with metallic heating resistors

IEC EN 60398 Installations for electro heating and electromagnetic processing – General test methods

IEC EN 60417 Graphical symbols for use on equipment

This standard covers all the icons and symbols you would typically put on your equipment. For example, start stop EMO electrical hazard and other hazards. We can help you design your equipment to meet this requirement.

IEC EN 60445 Basic and safety principles for man-machine interface

IEC EN 60446 Wiring colors

IEC EN 60479 Effects of current on human beings and livestock

IEC EN 60519 Safety in installations for electro heating and electromagnetic processing

IEC EN 60529 Degrees of protection provided by enclosures (IP Code)

In order to place your equipment on the market, you need to be sure that you have properly designed the enclosure for your electrical components. How do I be sure my enclosure meets IP code? We will help design, evaluation and test. and validate your equipment.

IEC EN 60598 Luminaires

IEC EN 60601 Medical Electrical Equipment

You need your lighting products certified for CE. How to get my lighting product certified for CE? This is a standard you would use, and we can help you get their specific requirements for grounding, wall plugs cord caps and wiring. This is one of the key standards our team works to currently. We have several medical equipment projects in process, and several more to kickoff shortly. How to get my medical equipment certified for CE? How to get my medical equipment UL listed? We would use this standard as the base standard, and then look at other standards for other hazards associated with the equipment. Then we would complete a preliminary design evaluation and provide you a gap analysis. How do I design medical equipment to meet CE requirements? Take a look at your equipment and determine what details need to be in place and complete on that. From there you’ll be able to complete your design, provide prototypes for preliminary testing and production samples for final testing. Also, how do I have the proper labeling and documentation for medical equipment? We can help with that as well. We can provide you the boilerplate for the standard to complete yourself, or we can support you with our internal or external technical writing teams.

IEC EN 60617 Graphical symbols for diagrams

IEC EN 60664 Insulation coordination for equipment within low-voltage systems

IEC EN 60669 Switches for household and similar fixed-electrical installations

IEC EN 60680 Test methods of plasma equipment for electro heat and electrochemical applications

IEC EN 60812 International Standard on Fault Mode and Effects Analysis

IEC EN 60825 Laser safety

I have a laser product, how to get certified? How to get a laser product certified for CE? Can lasers be certified for CE? European Union has significant restrictions on which lasers can be sold to sewers, and details on how to provide lasers to end-user industrial. To get your laser product CE marked, we will review the product, do testing, including EMC EMI, laser mission testing, near and far field testing and then any interlocking documentation or labeling that is required. For simple laser product, you can expect this to be about $8,000 to $10,000. For a very complex and difficult piece of laser equipment, just add for the additional hazards.

IEC EN 60874 Connectors for optical fibers

IEC EN 60950 Safety of information technology equipment

This is the old standard. The new standard is replacing the standard; IEC 60950 – 1 and IEC 60065 have been merged to form the new standard by IEC 62360 – 1. We can certainly help you get approvals for the new standard IEC 62360. How do I get my business equipment CE Mark? How I get my IT equipment CE marked? How I get my audio or entertainment equipment, CE marked? All those questions bring back the same standard. Using our Conformity Discovery Process©, we will be able to help you accelerate your testing and approvals to get you CE marked in weeks…not months. In some cases, we can CE mark products within three days, if all the design is correct and the proper documentation is available.

IEC EN 61010 Safety requirements for electrical equipment for measurement, control and laboratory use

This is one of our keys standards IEC 61010. We perform hundreds of evaluations to this standard. How do I get my equipment CE marked to IEC61010? We can help you perform that testing and evaluation, and provide you with a CE Mark, conformity documentation and certificate of conformity. We use a practical and reasonable approach to get your equipment validated rapidly allowing us to get this project out for you quickly. How fast can I get CE Mark? You can get a product CE marked within a few days, if you have all the details and overnight ship a sample. Often times we can work with you over the phone or on zoom to identify product shortfalls, get those corrected, and provide you the proper documentation templates, so that you can have this thing fully CE marked as quickly as possible.

IEC EN 61025 Fault tree analysis

IEC EN 61084 Cable trucking and ducting systems for electrical installations

IEC EN 61241 Electrical apparatus for use in the presence of combustible dust

IEC EN 61277 Terrestrial photovoltaic (PV) power generating systems – General and guide

IEC EN 61307 Industrial microwave heating installations – Test methods for the determination of power output

IEC EN 61308 High-frequency dielectric heating installations – Test methods for the determination of power output

IEC EN 61346 Industrial systems, installations and equipment and industrial products – Structuring principles and reference designations

IEC EN 61508 Functional safety of electrical/electronic/programmable electronic safety-related systems

We perform systemic and other validations of functional safety products. I need to validate my functional safety product for CE marking, how do I do that? You would use this standard and we would help you get it done.

IEC EN 61511 Functional safety – safety instrumented systems for the process industry sector

IEC EN 61558 Safety of power transformers, power supplies, reactors and similar products

IEC EN 61603 Infrared transmission of audio or video signals

IEC EN 61642 Industrial a.c. Networks Affected by Harmonics – Application of Filters and Shunt Capacitors

IEC EN 61643 Surge protective devices connected to low-voltage power distribution systems

IEC EN 61646 Thin-film terrestrial photovoltaic (PV) modules – Design qualification and type approval

IEC EN 61690 Electronic design interchange format, EDIF

IEC EN 61724 Photovoltaic system performance monitoring – Guidelines for measurement

IEC EN 61727 Photovoltaic (PV) systems – Characteristics of the utility interface

IEC EN 61730 Photovoltaic modules

IEC EN 61784 Industrial communication networks – Profiles

IEC EN 61800 Adjustable speed electrical power drive systems

IEC EN 61829 Crystalline silicon photovoltaic (PV) array – On-site measurement of I-V characteristics

IEC EN 62040 Uninterruptible power systems

IEC EN 62076:2006, Industrial electro heating installations – Test methods for induction channel and induction crucible furnaces

IEC EN 62108 Concentrator photovoltaic (CPV) modules and assemblies – Design qualification and type approval

IEC EN 62262 Degrees of protection provided by enclosures for electrical equipment against external mechanical impacts (IK code)

IEC EN 62282 Fuel cell technologies

IEC EN 62301 Household electrical appliances – Measurement of standby power

IEC EN 62353 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment

IEC EN 62366 Medical devices – Application of usability engineering to medical devices

IEC EN 62395 Electrical resistance trace heating systems for industrial and commercial applications

IEC EN 62471 Photobiological safety of lamps and lamp systems

How to get my LED, laser, or other high intensity lamp source approved for CE marking? This is how you get your laser CE marked.This and the above standard IEC60825 are the key standards for laser LED and high intensity lab source CE marking.

IEC EN 62502 Analysis techniques for dependability – Event tree analysis (ETA)

IEC EN 62693 Industrial electro heating installations – Test methods for infrared electro heating installations

IEC EN/TS 62796 Energy efficiency in electro heating installations

IEC EN 62798 Industrialelectro heating equipment - Test method for infrared emitters

Let Us Help You Find The Right Standard

Process

We help walk our clients through the process to design based on the standards that it will be tested to and need to comply with in order to enter your desired market.

Timeline

We can offer a basic timeline to get your product through the process and steps that you can take that will help to expedite the process. Each piece of equipment is different and we can quote your specific equipment.

Cost

$22-30K for most equipment. There are factors that you can anticipate will add to the cost and can be planned for in your budget.

Resources From The Field

CE Marking

Outline of HTDS Conformity Discover Process for getting your product listed, labeled and certified

This is the next addition to our video series on getting your product listed, labeled or certified. Today our CEO, Steve Barcik Amstel is going to speak about the Conformity Discovery Process and how using our process can save you time and money when getting your product to market. Link to video also available here: https://youtu.be/2gt8OZB0CsM The

May 20, 2020 No Comments

CE Marking

Your Products Listed Faster Through Conformity Discovery Process

How do you get your product to market faster? How can you reduce engineering and design costs, how can you shorten certification and listing timelines? As product certification, evaluation and testing lab, we here at High Tech Design Safety have seen all kinds of projects and various execution hurdles. How to get listed, how to

October 30, 2019 No Comments

CE Marking

Forecasting for 2020 Budgets

2020 is just around the corner and it is time to start planning your next year. Today, our CEO, Steve Barcik Amstel is reaching out to you to plant a seed that can help you in the coming year to bring more ease and success. Link to video also available here: https://youtu.be/QpNL3jZiT3M We are going into

October 24, 2019 No Comments

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