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):
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.
| 4th Ed. WG | WG Title | WG Task/Description | Proposed Nomination of Co-Convenors | Call for Convenors & Experts Document |
|---|---|---|---|---|
| WG 37 | General requirements | Develop requirements related to general issues with respect to underlying concepts (e.g., basic safety/essential performance, single fault safety, type testing), correlation with processes relevant for the IEC 60601-1 defined by other process standards (e.g., risk management) for the 4th edition of IEC 60601-1. | Mr. Richard Scott (UK) & Mr. Jos Van Vroonhoven (NL) | 62A/1544/Q |
| WG 38 | Physical environment hazards | Develop requirements to address safety issues due to specific environmental conditions, including power supply for the 4th edition of IEC 60601-1. | Mr. Michel Brossoit (CA) & Mr. Brodie Pedersen (US) | 62A/1545/Q |
| WG 39 | User interface aspects (including all labelling and information to be provided) | Develop requirements to address safety issues related to user interfaces including marking, indications, accompanying information, alarm systems and usability for the 4th edition of IEC 60601-1. | Mr. Leo Eisner (US) & Mr. Martin Stangenberg (DE) | 62A/1549/Q |
| WG 40 | Materials hazards | Develop requirements to address safety issues related to interferences of materials of MEE/MES with users, patients, used substances, including cleaning, disinfection, sterilization for the 4th edition of IEC 60601-1. | No co-convenors nominated. | 62A/1541/AC |
| WG 41 | PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards | Develop requirements to address hazards related to software driven functionality of MEE/MES for the 4th edition of IEC 60601-1. | Mr. Jullian Goldman (US) & Ms. Patty Krantz-Zuppan (US) | 62A/1550/Q |
| WG 42 | Electrical hazards | Develop requirements to address safety issues related to electricity for the 4th edition of IEC 60601-1. | Mr. Alex Grob (US) & Mr. Martin Schneeberg (DE) | 62A/1547/Q |
| WG 43 | Mechanical hazards | Develop requirements to address safety issues related to mechanics, including acoustic and pneumatic energy and vibration energy for the 4th edition of IEC 60601-1. | No Call for experts or nomination of co-convenors sent yet. Expect by sometime early Jan 2024. | Not issued yet |
| WG 44 | Thermal and fire hazards | Develop requirements to address safety issues related to thermal effects caused by MEE/MES and to fire in MEE or MES for the 4th edition of IEC 60601-1. | Mr. Andreas Nilsson (NO) & Mr. Ayub Yancheshmeh (CA) | 62A/1548/Q |
| WG 45 | Optical radiation (visible, UV and IR) hazards | Develop requirements to address safety issues related to (visible radiation, UV and or IR) for the 4th edition of IEC 60601-1. | Mr. Winn Henderson (US) & Ms. Yaqing Liu (US) | 62A/1546/Q |
| WG 46 | Ionizing radiation hazards | Develop requirements to address safety issues related to ionizing radiation for the 4th edition of IEC 60601-1. | No Call for experts or nomination of co-convenors sent yet. Expect by sometime early Jan 2024. | Not issued yet |
| WG 47 | Electromagnetic exposure hazards (not optical or ionizing but including SAR) | Develop requirements to address safety issues related to radiation (not optical or ionizing radiation hazards but including SAR) for the 4th edition of IEC 60601-1. | No co-convenors nominated. | 62A/1541/AC |
| WG 48 | Electromagnetic disturbances hazards (including coexistence) hazards | Develop requirements to address safety issues related to electromagnetic emissions or electromagnetic immunity, (including wireless coexistence) for the 4th edition of IEC 60601-1. | Mr. Harald Buchwald (DE) & Mr. Curt Sponberg (US) | 62A/1551/Q |
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.
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