This is a follow-up to IEC 60601-1, 4th Ed. – Time to Get Involved Is Now! and IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 Nov 2023. 3 Weeks after the initial Nomination of experts and Co-conveners went out on 22 Dec 2023, the last 2 Working Group (WG) Q documents were released on 12 Jan 2024 for WG43 Mechanical Hazards and WG46 Ionizing Hazards. For WG43 & WG46 the Q document nomination period ends on 23 Feb 2024.
Having new people (young and old alike) interested in joining all the new WGs (12 in total) who have the technical experience and expertise for the WG subject matter (not all subjects within a WG but some and each National Committee (NC) decides on its selection process and criteria).
Some NCs may accept experts after the applicable Q documents close (no guarantee which countries) but if you wait too long you won’t be able to join the kickoff meeting for the IEC 60601-1, 4th ed. project. The meeting 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 for a specific WG.
So, stop waiting to become an expert on 1 of the 12 WGs for IEC 60601-1, 4th ed. Now is the time to take action & contact your National Committee to get nominated as an expert.
I have updated the table in the IEC 60601-1, 4th Ed. – Time to Get Involved Is Now! post to include the two new WG Q documents (WG43 & WG46) just released so all in one place – below. The two previous posts discuss nominations of experts and considerations of being an expert. Please review before putting your name in for nomination.
| 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. | Ms. Pamela Gwynn (US) & Mr. Roland Hans (DE) | 62A/1552/Q |
| 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. | Mr. Jan Jans (NL) & Mr. Damien Kopyto (DE) | 62A/1554/Q |
| 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 |
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