See the original post of 3 Nov 2023
Some History
The “Architectural Specification for Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, & Software Used in Healthcare”, vers. 3.0, issued 5 May 2020. One of the reasons for the document it was to be used by those who prepared the design specification of IEC60601-1, 4th edition. You can access this document https://lnkd.in/gWSqEnPQ.
A resolution @ the 2015 Kobe meeting of IEC SC62A that once the Architecture Specification is approved IEC SC 62A will start to prepare a Design Specification (Dsgn Spec) for the IEC 60601-1, 4th ed.
The finalized version of the Dsgn Spec to IEC 60601-1 4th ed. was just approved & placed on the IEC SC62A website on 30 Nov 2023. You can access it at this post - attached, or at https://lnkd.in/g_4MxW9K & select the “Design Specification Outline for the fourth edition of IEC 60601-1” document.
This Dsgn Spec has been developed to provide guidance & mapping for drafting IEC 60601-1, 4th ed. 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, & easily readable edition of IEC 60601-1. It is a guidance document that will help the Working Groups (WGs – Clusters) 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 4th 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 (Detailed in the previous post mentioned at the top of this one).
There is a 6-week voting period that will end 8 Dec 2023 for the Q doc. Once the voting period is completed an affirmative result is anticipated for this Q doc from the NCs (based on the Seoul meeting’s positive response from the NCs).
The next step is a 2nd Q doc will be sent out for a call for experts and conveners about 1 week or sometime just after the first of Jan 2024 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 1st Q doc for IEC 60601-1, 4th ed.
If you or your company, the notified body, the regulator you work for want to be involved in the development of the 4th 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, 4th 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 2nd Q doc. To be a member of a WG as an expert you will need to commit to two (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 2nd 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 & younger 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.
Thx much and I look forward to our discussion on this topic and much more to come.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------