Frequently asked questions
Hereafter is a list of questions people frequently ask about the IECEE
The IECEE Medical Electrical Equipment Task Force considered the issue of certification of power supplies that may be incorporated into medical electrical equipment which are intended to be certified to IEC 60601-1: 2005, 3rd Edition.
The RM Task Force acknowledged that there are other concerns related to component medical electrical equipment (e.g. RF amplifier, ultrasound transducer). This recommendation however is only applicable to power supplies. Additional study is needed to address these other components.
Consider the following possible scenarios:
1) A component power supply may be certified to a number of standards other than IEC 60601-1: 2005. If that component power supply is subsequently incorporated into a medical electrical equipment or system, the complete equipment including the power supply will be evaluated for certification against all applicable clauses/requirements of IEC 60601-1: 2005, including all applicable risk management requirements.
2) A component power supply can be issued its own CB Test Certificate to IEC 60601-1:2005, 3rd Edition. Where the supplier does not perform a risk management process as required by IEC 60601-1:2005, 3rd Edition:
- the CB Test Certificate shall have the risk management process exclusion clearly stated (see note below);
- all applicable type testing required for component power supplies shall be performed;
- in cases where compliance with a requirement relies entirely on risk management process, the component power supply manufacturer must provide documentation indicating how the relevant clauses were addressed (for example, Clauses 8.10.1, 8.10.2, 8.10.5, and 8.11.5);
- partial application of the risk management process is not permitted. If the risk management process is used to modify/reduce any requirement in the standard then the full risk management process must be performed using the entire standard IEC 60601-1:2005, 3rd Edition, as applicable.
Note: The following wording may be used on the Certificate: â€œThe risk management requirements of the standard were not addressed.â€
3) Power supplies meant for specific use in Medical Electrical Equipment (e.g. Medical Grade High Voltage Power Supplies/Generators for X-Ray Equipment) must additionally meet the applicable requirements from relevant particular standards (e.g. IEC 60601-2-43, IEC 60601-2-54).
4) If a power supply is submitted for CB Test Certificate against IEC 60601-1: 2005 as a stand-alone product it will be evaluated against all clauses/requirements of the standard that are applicable for that device. This will include the full risk management process using the entire standard IEC 60601-1:2005, 3rd Edition, as applicable.
It is permitted to issue a CB Test Certificate to IEC 60825-1 alone, with the following disclaimer: â€œOnly hazards resulting from laser radiation have been addressed. Stand-alone certificates for laser products covered by 60825-2 and 60825-12 also require a disclaimer, such as: Only hazards resulting from laser radiation have been addressed.
Please contact the IECEE Secretariat.
Currently, there are four stages for manufacturers to operate under in the Customers' Testing Facilities (CTF) program:
Stage 1 - Full testing carried out by CBTL staff or qualified Local Technical Representative (LTR) at CTF
Stage 2 - Witnessing 100 per cent of each test program
Stage 3 - Witnessing selected parts of each test program
Stage 4 - Witnessing selected parts of selected test programs
Please refer to OD-2048 for more information.
You can either ask the retailer to provide a copy of the certificate or ask the organization (NCB) that appears in the rating plate identified by the certification mark. A list of all our NCBs, as well as their contact information can be found on our website at: Members > National Certification Bodies
You can also check the public area of our Online Deliverables site to see if a CB Test Certificate has been issued. Note: not all certificates issued in the restricted area are made public.
The CB Bulletin in its old format has been discontinued. Most of the information it contained is, however, freely accessible from the IECEE website.
Access to the detailed differences information is restricted to IECEE Members (for example Member Bodies, National Certification Bodies, etc.). If you require detailed information on declared national and group differences, we suggest you contact your National Certification Body directly who will be able to assist you further (see: National Certification Bodies for a complete listing and contact details).
Interested parties and stakeholders may provide feedback to the IECEE System directly. We welcome feedback on Operational issues or concerns impacting the acceptance of IECEE System Certificates, Reports or other related deliverables.
Information on EN standards can be obtained by using the search facilty on the CENELEC website.
Information on IEC Standards can be obtained by using the search facilty on the IEC Webstore.
Operated by the IEC System of Conformity Assessment Schemes for Electrotechical Equipment and Components (IECEE), the IECEE CB Scheme is an international system for mutual acceptance of test reports and certificates dealing with the safety of electrical and electronic components, equipment and products.
It is a multilateral agreement among participating countries and certification organizations, which aims to facilitate trade by promoting harmonization of national standards with International Standards and cooperation among accepted National Certification Bodies (NCBs) worldwide. By achieving this, it brings product manufacturers a step closer to the ideal concept of "one product, one test, one mark, where applicable". More...
CB Test Certificates are valid as long as the certified products remain to confirm with the initial certification unless canceled on the Licensee's request.
Membership: 3000 CHF for the Member Body, 1000 CHF for the NCB and 1000 CHF for the CBTL
Assessment cost (for NCBs and CBTLs only)
Assessment Fees: The lead assessor will charge 1250 CHF per day including travelling time and the assessors 1000 CHF per day.
Travelling Fees: At real cost-tickets provided with the Invoice
Accommodation: Hotel and meals directly paid by the candidate NCB/CBTL.
Annual dues are shared among the Member Country's. Please refer to OD-2026 for details on the calculation method.
NCBs acceptance process
From the time the application is forwarded and accepted to the final acceptance depends very much on when the assessment takes place and the nature and extent of nonconformities raised by the assessment team.
It can be two or six months, all depends very much on the result of the assessment.
As per the rules there will be 3 assessors for 2/3 days, however, depending on the size of your certification body/laboratory and the H.R. involved with the testing and certification, the size of the Assessment Team may vary.
The application batch is determined in Operational Document OD-2007.
If the request for the Secretariat to take action requires CMC approval (for example changes in the rules, structure of the IECEE, important changes to IT tools, etc.), the Convenor/Chair shall include such a request in their report to the CMC, in section "A". If the request to the Secretariat is for information or small changes (e.g. updating of information in the website), the Convenor/Chair shall send an e-mail to the Secretariat, detailing the request. Please note that the Secretariat does not systematically read all reports posted in the collaborate platform or sent by e-mail, so any action needed by the Secretariat needs to be notified separately. Committees where the Secretariat is acting as the Secretary of the Committee as well, are exceptions.
If your company/organization is interested in selling and distributing IECEE publications, please contact your IECEE Member Body.
It is strictly forbidden to make reference to the IECEE or CB Scheme on your product.
No, IEC 60601-1 3rd does not require a registered ISO 14971 risk management system. IEC 60601-1 3rd Edition has numerous specific requirements calling up ISO 14971 clauses throughout the standard. In some cases those IEC 60601-1 requirements call up specific risk management requirements such as risk analysis or risk assessment which requires that those appropriate clauses of ISO 14971 be met. In other cases those IEC 60601-1 requirements are more general and require compliance with several of the clauses of ISO 14971. Evidence of compliance with the required clauses of ISO 14971 will be recorded in the risk management file.
No, registration to ISO 13485 provides no information about meeting the requirements of either IEC 60601-1 3rd Edition or the risk management requirements of ISO 14971 that are required by the IEC 60601-1 3rd Edition. Registration to ISO 13485 Quality Management Systems provides evidence that the manufacturer has a quality management system in place meeting the requirements of that standard only.
No, there is no formal IECEE agreement related to registration to ISO 14971, Medical devices- Application of risk management to medical devices. There are some certification organizations which do audits to ISO 14971 and the information from those audits may provide useful information for the assessment conducted by a CB testing organization against the requirements of IEC 60601-1 3rd Edition. However, that is not part of any requirements or guidance under the IECEE CB Scheme.
Question: We manufacture non-invasive blood pressure modules which are integrated into medical devices such as patient monitors, dialysis machines, defibrillators and other devices that need non-invasive blood pressure technology. The module is considered a component of the system as we do not provide an enclosure, display, power supply or end-user documentation.
In the past, we were able to obtain CB certificates for our modules. The corresponding test reports included passing results for the requirements that our module could meet related to patient safety and clinical performance but had â€œnot applicable, responsibility of the host systemâ€ for requirements that had to be met by the host system such as the features I mentioned in the paragraph above. We recently tried to obtain another CB certificate but were told that recent changes to the rules would not allow the NCBs to issue CB certificates for components except for medical grade power supplies.
I am writing to you to see if you could provide any clarification to this issue. If we can no longer obtain CB certificates for our blood pressure modules, we want to understand why and preferably reference a source that indicates this restriction. Our customers are asking for the CB certificate and we have no explanation right now other than the NCB has refused to issue it to us on the grounds that our module is a component.
Reply: A CB test certificate is not allowed to be issued for a component non-invasive blood pressure module which subsequently may be integrated into medical devices such as patient monitors, dialysis machines, and other devices that require non-invasive blood pressure technology.
The IEC 60601 Series of standards covers medical electrical equipment in the General standard, the Collateral standards, and the Particular standards. Except in a few cases, the series does not address modules except where it is included as part of an equipment. A typical component is incomplete and cannot comply with all normally applicable requirements of the standard(s) such as construction and risk management. All requirements of the General standard 60601-1 3rd Amend 1, the Collateral standards, and all appropriate Particular (Part II) standards would apply. Within the IECEE CB Scheme conformance of the medical electrical equipment, including the integrated component, to each and all applicable standards has always been necessary in order for a CB Certificate to be issued.
Please click here in order to access the most frequently asked questions pertaining to the transition from MTL to CTF.
The requirements in order to become a registered IECEE Technical Expert (Assessor) are:
- Education: Engineer or similar educational level
- Total work experience: 5 Years in the electrotechnical sector field
- Expertise, Experience & addition to training within the NCB and/or CBTL, IECEE training courses are mandatory.
The requirements in order to become a registered IECEE Lead Assessor are:
- Education: Graduate engineer or similar educational level
- Total work experience: 5 additional years at management level
- Minimum of 3 assessments as a Technical Assessor
- 3 recommendations from other Lead Assessors
- Must have attended at least 2 assessor training workshops
- No initial assessments will be assigned in the first year after becoming a Lead Assessor
- Technical Assessor must file an application to become Lead Assessor and provide AD-001 duly filled in
Both IECEE Technical Experts(Assessor) and IECEE Lead Assessors need to be sponsored by an IECEE National Certification Body (NCB) or IECEE CB Testing Laboratory (CBTL). To submit an application, AD-001 needs to be filled in, endorsed by the NCB and then submitted to the IECEE Secretariat .
CB stands for Certification Body(ies)
The accronym OSM stands for "Operational Staff Meeting", this accronym is used by EEPCA.
Please note that CE Marking is a symbol. The IEC and IECEE are not involved with it.
CE Marking is the symbol. The letters "CE" are the abbreviation of French phrase "Conformité Européenne" which literaturely means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term.
1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives.*
*Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
CEN stands for European Committee for Standardization.
CENELEC stands for European Committee for Electrotechnical Standardization.
2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
3. CE Marking on a product ensures the free movement of the product within the EU single market, and
4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.
Therefore, we suggest you directly contact CENELEC as they will certainly be able to help you with your request.
There is no comparison between CE marking and the CB Test Certificate. The CB Test Certificate is issued based on third party testing of samples of the products against a published IEC standard, while the CE marking is a regulatory marking to enter the European market and constitutes a declaration by the manufacturer that the product complies with the essential requirements as set in the Low Voltage Directives.
Please refer to our About the IECEE section for details.
IECEE, the IEC System for Conformity Assessment Schemes for Electrotechnical Equipment and Components, is a multilateral certification system based on IEC International Standards. Its Members use the principle of mutual recognition (reciprocal acceptance) of test results to obtain certification or approval at national levels around the world.
The IECEE Schemes address the safety, quality, efficiency and overall performance of components, devices and equipment for homes, offices, workshops, health facilities among others. In all, IECEE covers 23 categories of electrical and electronic equipment and testing services.
- The IECEE CB Scheme is based on the principal of mutual recognition between all participants in the IECEE CB Scheme. Per IECEE 02 Clause 4.3, the mutual recognition process takes place between participating National Certification Bodies (NCBs), and should not be confused as to being between Member Bodies (Countries). In summary, an IECEE CB Test Certificate and its related report, issued by a NCB with the relevant scope, shall be recognized by all other participating NCBs for use within their own national/local Certification Scheme or system.
- The new UK Conformity Assessment (CA) marking, details can be found here: https://www.gov.uk/government/publications/prepare-to-use-the-ukca-mark-after-brexit/using-the-ukca-marking-if-the-uk-leaves-the-eu-without-a-deal
Since the UK CA marking has not been fully approved in UK, yet, there isnâ€™t a fully implemented process yet available. However, as a Suppliers Declaration of Conformity (SDoC), the UK CA Conformity mark would not be covered in the IECEEâ€™s mutual recognition Scheme, since itâ€™s not a certification issued by one of the IECEEâ€™s UK based NCBs. As per the current understanding, an IECEE CB Test Certificate and its related test report could be utilized by the manufacturer as part of their technical file for UK CA marking, specifically for those aspects covered by the CB Test Certificate. In the case that there are national differences to the standard or additional regulatory requirements applicable, these would have to be covered, additionally.
- The CE marking is not a certification mark and, for the majority of products and related European Directives, the mark is based on a self-declaration process. With a CE marking on the product, it is a declaration by the manufacturer that the product complies with ALL applicable European directives, to also include issues such as chemical hazards, waste and recycling and other aspects. Similarly like the UK CA marking, CE is not a certification directly issued by a Certification Body or NCB and, therefore, not directly covered by the IECEE mutual recognition process. However, also in this case, the IECEE CB Certificate and its related test report can be used by the manufacturer, as part of their technical file, to show compliance with the aspects covered by the CB Test Certificate. The group differences for the CENELEC Countries, which are usually implemented in the EN version of the applicable standard(s), need to be taken into account, additionally, to those requirements specified by the IEC version of the standard. The CENELEC group differences are intended to cover differences between the IEC version of a standard and the European Directives.
From the IEC point of view, a new edition replaces the old one as soon as it is published.
From the IECEE side, where certification of a product is concerned, the testing and certification carried out for the older edition remains valid as long as no changes are made to the product, there therefore is no change over period. You may, of course, at any time, have your product tested and certified to the newer edition if you wish.
The complete list of IEC Standards operated by the IECEE is available here:
Testing & Certification > IEC Standards
For National and/or Group Differences go to: Testing & Certification > IEC Standards, click on a standard of your choice and then select the "Nat.Group Differences" tab.
If you wish to obtain International Certification, you can select one of our numerous NCBs (National Certification Bodies) located world-wide. A list of NCBs can be found on our website under: Members > National Certification Bodies
Select an NCB of your choice in order to obtain contact and other information.
IEC standards can be purchased from the IEC Webstore.