{"id":7826,"date":"2025-06-28T01:09:39","date_gmt":"2025-06-28T01:09:39","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7826"},"modified":"2025-06-28T16:39:03","modified_gmt":"2025-06-28T16:39:03","slug":"%f0%9f%8e%a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%e2%80%bc%ef%b8%8f-%f0%9f%9a%80","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2025\/06\/28\/%f0%9f%8e%a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%e2%80%bc%ef%b8%8f-%f0%9f%9a%80\/","title":{"rendered":"\ud83c\udfa9 Get your reviewer\u2019s hat on – IEC 60601-1, 4th Edition Draft Fragments Have Dropped\u203c\ufe0f \ud83d\ude80"},"content":{"rendered":"\n
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Posted on LinkedIn June 19, 2025. Updated with extra blog content June 25, 2025.<\/p>\n\n\n\n

Over the last two weeks \u2013 and with a Friday night (6\/20\/25 Geneva time – late) finale still to come \u2013 we\u2019ve seen CD1s and CD2 (WG 47 ONLY)<\/strong> fly out for Fragments 5, 6, 7, 8, 10, 11, and 12 <\/strong>from WG 41 through WG 48, but for WG 45<\/strong>. <\/p>\n\n\n\n

This is not just standards spring cleaning – these are foundational changes<\/strong> to the IEC 60601-1 General Standard, folding the Collateral standards into the core<\/strong>. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD you need to be aware of these changes<\/strong>. If you\u2019re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk file\u2026 you need to review this.<\/p>\n\n\n\n

These fragments cover hazards related to<\/strong>: \u2022 Electrical, mechanical, thermal, and fire \u2022 Software & PEMS (SaMD, SiMD, firmware, OS\u2026) \u2022 EM Disturbance, wireless coexistence, ionizing radiation, and electromagnetic exposure (EMF)<\/p>\n\n\n\n

\ud83d\udd50 The International comment deadlines start closing August 29th, with more due by September 12th. National deadlines close much sooner (does your summer holiday schedule conflict?\ud83c\udf79\ud83c\udfdd\ufe0f)<\/strong><\/p>\n\n\n\n

\ud83d\udcce Don\u2019t wait for the FDIS \u2013 get involved now or get caught off guard later.

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\ud83d\udc49 Read the full breakdown of all Working Groups, due dates, and what you should do now:<\/p>\n\n\n\n

Here\u2019s the who\u2019s who of the Working Groups behind the fragments with CD1 to issue 20 July:<\/p>\n\n\n\n

\u2022 WG 41<\/strong> \u2013 PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards \ud83d\udd17 WG 41 link<\/a><\/p>\n\n\n\n

\u2022 WG 42<\/strong> \u2013 Electrical hazards \ud83d\udd17 WG 42 link<\/a><\/p>\n\n\n\n

\u2022 WG 43<\/strong> \u2013 Mechanical hazards \ud83d\udd17 WG 43 link<\/a><\/p>\n\n\n\n

\u2022 WG 44<\/strong> \u2013 Thermal and fire hazards \ud83d\udd17 WG 44 link<\/a><\/p>\n\n\n\n

Other Fragments CD1s & CD2 have recently published – clock ticking \ud83d\udd70\ufe0f to get your comments in:<\/strong><\/p>\n\n\n\n

\u2022 Fragment 11 \u2013 WG 47<\/strong>: Electromagnetic exposure hazards (not optical or ionizing but including SAR) \ud83d\udd17 WG 47 link<\/a> CD2<\/strong>, closes 29 August<\/strong><\/p>\n\n\n\n

\u2022 Fragment 10 \u2013 WG 46<\/strong>: Ionizing radiation hazards \ud83d\udd17 WG 46 link<\/a> CD1<\/strong>, closes 5 September<\/strong><\/p>\n\n\n\n

\u2022 Fragment 12 \u2013 WG 48<\/strong>: Electromagnetic disturbances (including wireless coexistence) \ud83d\udd17 WG 48 link<\/a> CD1<\/strong>, closes 5 September<\/strong><\/p>\n\n\n\n

The early pack of CD1 Fragments released late last year<\/h3>\n\n\n\n

Fragments 1\u20134<\/strong> and 11<\/strong> from WG 37\u201340 & WG 47<\/strong> were released as CD1 back on December 6, 2024<\/strong>, with comments closing February 28, 2025<\/strong>. You can still access them if you\u2019re a National Committee member for SC62A or a WG participant. If not, consider joining \u2014 this is a major transformation, and early awareness = better preparation. \ud83d\udd17 Access link<\/a><\/p>\n\n\n\n

Here’s a handy summary table of the IEC 60601 Fragments, their WG #s, their titles, the issue & close dates & more.<\/p>\n\n\n\n

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Who Should Be Reviewing<\/h3>\n\n\n\n