Some History

The “Architectural Specification for Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in Healthcare”, version 3.0 was issued 5 May 2020. One of the main reasons for the document it was intended to be used by those who prepared the design specification of the 4^th edition of IEC 60601-1. You can access this document.

A resolution at the 2015 Kobe meeting of IEC SC62A that once the Architecture Specification (document noted above) is approved IEC SC 62A will start to prepare a Design Specification (Dsgn Spec) for the 4^th edition of IEC 60601-1.

The finalized version of the Design Specification to the 4th ed. of IEC 60601-1 was just approved and was placed on the IEC SC62A website as of 30 November 2023. You can access it here and selecting the “Design Specification Outline for the fourth edition of IEC 60601-1” document . It is available for free at the link provided.

This Dsgn Spec has been developed to provide guidance and mapping for drafting the 4th edition of IEC 60601-1. The aim of the Dsgn Spec is to provide a clear & concise basis for developing the next edition of IEC 60601-1. It is intended to provide information to develop a user-friendly, distinct, and easily readable edition of IEC 60601-1. It is a guidance document that will help the Working Groups (WGs – Clusters – see below) understand what are the main topics to cover. It will be up to the WGs to do the heavy lifting and write the actual requirements.

Going forward with the Fourth Edition of IEC 60601-1

During the IEC TC62 / SC62A meetings in Seoul, South Korea, 18 – 22 Sept 2023 there was general consensus between the National Committees (NCs) to move forward with the IEC 60601-1 4^th edition project. Yeah, finally after so many years!!!! A questionnaire (Q document 62A/1528/Q) dated 2023-10-27 was sent out to the NCs to get formal approval for the project to start and for establishing the new Working Groups (WGs) for 12 new WGs.

The 12 new WGs are:

• General requirements
• Physical environment hazards
• User interface aspects (including all labelling and information to be provided)
• Materials hazards
• PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards
• Electrical hazards
• Mechanical hazards
• Thermal and fire hazards
• Optical radiation (visible, UV and IR) hazards
• Ionizing radiation hazards
• Electromagnetic exposure hazards (not optical or ionizing but including SAR)
• Electromagnetic disturbances hazards (including coexistence) hazards

There is a 6-week voting period that will end 8 Dec 2023 for the Q doc.  Once the voting period is completed it is anticipated that there will be an affirmative result for this Q doc from the NCs (based on the Seoul meeting’s positive response from the NCs).

The next step is a 2^nd Q doc will be sent out for a call for experts and conveners about 1 week after 62A/1528/Q closes. The call for conveners and experts will be for the new WGs. Note that the current experts for the existing WGs, Joint WGs, and Maintenance Teams (MTs) will not be registered for the new WGs. So, all interested experts must be nominated by the NCs’ Secretaries when the call for experts is circulated after the establishment of these new WGs is approved. This 2nd Q doc will likely identify most, if not all the conveners and secretaries for each cluster (WG) for the 12 new WGs established in the 1^st Q doc for IEC 60601-1, 4^th ed.

If you or your company, the notified body, the regulator you work for want to be involved in the development of the 4^th ed. of IEC 60601-1 you need to make sure the organization you work for needs to make sure you are either already a member of your NC IEC SC62A (but first to the appropriate NC mirror committee so you can then be nominated to the IEC SC62A and applicable WG’s – this all takes time and with some big companies this can be a very long process & political) or if not you better start the process ASAP so you don’t miss the window to get added as a member of the WGs.

The kickoff meeting to start the work on IEC 60601-1, 4^th ed. will be held at AAMI in the US (Virginia) the week of 29 April – 3 May 2024. This is a closed meeting – you have to be nominated as an NC expert, as mentioned above, through the 2^nd Q doc. To be a member of a WG as an expert you will need to commit to 2 face to face meetings that run approximately 1 week each year (but one of the meetings I plan on it being 2 weeks a year and if you are interested I can talk to you more about those details – contact me) and approximately 3+ hours/month of virtual meetings plus additional time to support the work of the WG. This information will likely be stated in the 2^nd Q doc. Currently, from what I am hearing, it sounds like experts will be limited to a maximum of 2 WGs, but this hasn’t been confirmed for sure.

“this is a great opportunity to get some newer individuals involved in developing the IEC 60601-1 standard”

You will want to make sure you have the budget set up for travel for face to face meetings, time to focus on this work, and have the support of your organization before you commit to this work. IEC TC62 and SC62A are looking for additional people from the existing group of experts as many have either retired or are getting close to retirement or are in mid to late careers with few early in their careers. So, this is a great opportunity to get some newer individuals involved in developing the IEC 60601-1 standard who are familiar with the standard and have been in the medical device industry for some time. It would be ideal if they know 60601-1, have some design experience, have worked for a test lab, worked for a notified body or a regulator, understand the IEC 6060-1 compliance process, or similar. If you are interested in the process and have any questions about joining an NC please let me know.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

27 November 2023

The FDA announced today that it is withdrawing “as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.”

The letter sent to the GHWP can be downloaded or viewed below. It is pretty critical of the GHWP processes including leadership not being diverse or representative of a global perspective in the major committees; the imbalance of regulator and industry participation in working groups impacting work not representing the regulator’s perspective; and more….

Need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.