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

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):

• LinkedIn Comment 1
• LinkedIn Comment 2
• LinkedIn Comment 3

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 WG’s … multiple documents (were) released 22 Dec 2023 announcing a call for experts & a vote on nomination of convenors.

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 (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 National Committee (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, mentioned above, 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 below table.

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.

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