Hi Naveen, (Edits italicized, bolded, and in red font)
That is an excellent question and it's not a straight forward one to answer. There are no specific criteria written in the call for experts as each National Committee (NC) can have different criteria for nominating their experts so I don't want to overstep. Remember experts can come from industry, which includes manufacturers and consultants (sometimes called general interest), there are test labs, regulators, and notified bodies, auditing organizations, academics, and industry trade associations, and other interested parties are the primary writers of standards. Each group comes with different experiences and qualifications too. So, this is a really broad question.
I would say having a minimum of 5 - 10 years of experience in a specific area of focus that covers a Working Group or portion of a Working Group (i.e. for WG 39 a focus on alarms or labeling expertise would be fine for one expert) would be sufficient but again you have to submit your name through your national committee and it is up to them to pass on your nomination and get approved.
You can find your country's National Committee information for SC62A at https://bit.ly/IECSC62ANCMembership. Contact them for your NC process for nomination to one of the SC62A new WG's.
PS - Naveen - I'm also going to bring this discussion onto the Linkedthread on this topic as I think this is relevant and I will credit you (tag your name) with the original question. As I think this is a good point to bring up.
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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.com
Website: www.EisnerSafety.com
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Original Message:
Sent: 03-Jan-2024 08:37
From: Naveen Agarwal
Subject: IEC 60601-1, 4th Ed. - Time to Get Involved Is Now! (Resharing with additional update as of 2 Jan 2024)
Hello Leonard - thanks for this call to action. It would be helpful to provide some details of the kind of experience/qualifications you are looking for.
Best regards
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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
Original Message:
Sent: 03-Jan-2024 03:19
From: Leonard Eisner
Subject: IEC 60601-1, 4th Ed. - Time to Get Involved Is Now! (Resharing with additional update as of 2 Jan 2024)
Happy New Year All,
I'm resharing this post as it is on a short time period for those who want to get involved as an expert in the working groups (the vote period closes on 2 Feb 2024 for 8 of the 10 Working groups) and it is a New Year and hopefully many of you are now back from holiday and well rested now.
Update as of 4 Jan 2024: The 2 Working Groups that haven't sent out a Call for Experts should be released on 5 Jan 2024 or at the latest the Friday after. The 2 WGs that are missing currently are WG43 & WG46 (refer to table below).
We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development.
This is a follow-up to the original post of IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 November (Orig post 3 Nov 2023)
As I said in a LinkedIn Post conversation with Beat Keller ...we need bodies ... younger bodies... but I would like to amend this that we also need experienced professionals to get involved in the development of the 4th edition of IEC 60601-1 as our whole Technical Committee 62 (IEC TC62), which is the "mothership" for all things IEC 60601-1 titled "Medical equipment, software, and systems", is a ...graying society this group of standards writers I would say (my personal opinion). To see the conversation thread see the links below (order of conversation):
To get involved in the development of the 4th edition of IEC 60601-1 as our whole Technical Committee 62 (IEC TC62 https://bit.ly/TC62), which is the "mothership" for all things IEC 60601-1 titled "Medical equipment, software, and systems", is a "...graying society this group of standards writers I would say (my personal opinion)."
The Q doc 62A/1528/Q closed on 8 Dec 2023 with all the P-member National Committees (NC's) voting positively. A total of 35 NC's voted and they were all positive votes, some provided feedback. All 27 P-members - participating NC's voted. There were 15 O-members observing NCs that didn't vote.
The big news is that for 10 of the 12 Working Groups (WG's) noted in the Design Specification for the 4th ed. of IEC 60601-1 https://bit.ly/Download4thEd60601DsgnSpecFinal (free download) there were multiple documents released 22 Dec 2023 announcing a call for experts and a vote on the nomination of convenors. Below is a table with all the details. The end of the voting period for these documents is 2 Feb 2023. You'll want to submit your name thru your NC to become an expert on a WG almost immediately as the voting period depending on your NC could end 1 week to several weeks prior to the close date of the vote. So, if you want to become an expert with one of the 10 WG's get your name in through your NC. See the previous post IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 November (Orig post 3 Nov 2023) for more details. If you are a NC member please support my nomination for WG39 User interface aspects (including all labelling & info to be provided) as a Co-Convenor. There should be one or two more call for experts and nomination of convenors documents coming out soon (probably early 2024), with a 6 week voting period. This is also noted in the attached table.
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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.com
Website: www.EisnerSafety.com
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