Posted on LinkedIn June 19, 2025. Updated with extra blog content June 25, 2025.
Over the last two weeks – and with a Friday night (6/20/25 Geneva time – late) finale still to come – we’ve seen CD1s and CD2 (WG 47 ONLY) fly out for Fragments 5, 6, 7, 8, 10, 11, and 12 from WG 41 through WG 48, but for WG 45.
This is not just standards spring cleaning – these are foundational changes to the IEC 60601-1 General Standard, folding the Collateral standards into the core. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD you need to be aware of these changes. If you’re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk file… you need to review this.
These fragments cover hazards related to: • Electrical, mechanical, thermal, and fire • Software & PEMS (SaMD, SiMD, firmware, OS…) • EM Disturbance, wireless coexistence, ionizing radiation, and electromagnetic exposure (EMF)
🕐 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?🍹🏝️)
📎 Don’t wait for the FDIS – get involved now or get caught off guard later.
👉 Read the full breakdown of all Working Groups, due dates, and what you should do now:
Here’s the who’s who of the Working Groups behind the fragments with CD1 to issue 20 July:
• WG 41 – PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards 🔗 WG 41 link
• WG 42 – Electrical hazards 🔗 WG 42 link
• WG 43 – Mechanical hazards 🔗 WG 43 link
• WG 44 – Thermal and fire hazards 🔗 WG 44 link
Other Fragments CD1s & CD2 have recently published – clock ticking 🕰️ to get your comments in:
• Fragment 11 – WG 47: Electromagnetic exposure hazards (not optical or ionizing but including SAR) 🔗 WG 47 link CD2, closes 29 August
• Fragment 10 – WG 46: Ionizing radiation hazards 🔗 WG 46 link CD1, closes 5 September
• Fragment 12 – WG 48: Electromagnetic disturbances (including wireless coexistence) 🔗 WG 48 link CD1, closes 5 September
The early pack of CD1 Fragments released late last year
Fragments 1–4 and 11 from WG 37–40 & WG 47 were released as CD1 back on December 6, 2024, with comments closing February 28, 2025. You can still access them if you’re a National Committee member for SC62A or a WG participant. If not, consider joining — this is a major transformation, and early awareness = better preparation. 🔗 Access link
Here’s a handy summary table of the IEC 60601 Fragments, their WG #s, their titles, the issue & close dates & more.
Who Should Be Reviewing
- Design and Systems engineers
- Risk management experts/leaders
- Electrical & mechanical designers
- Software designers (SaMD/SiMD, firmware, OS)
- EMC/EMF compliance leads
- Compliance engineers
- Regulatory and quality teams
- Usability & human factors engineers
- Test labs
- Trade Associations
- Regulators
- Notified Bodies
- Other Interested Parties
✅ What You Need to Do
- Review the Drafts & the 4th ed. Design & Architecture Specs Now • Assign key experts by hazard/WG • Map against your design controls: Design Spec • Understand the architecture spec: Architecture Spec
- Track IEV Part 880 Terms • Stay aligned with the evolving definitions: Terms & Definitions
- Analyze Impact to Products • Run gap assessments • Identify implications for design, testing, and documentation
- Submit Comments • Through your National Committees (ANSI, BSI, DIN, etc.) • Clear, technically sound feedback = meaningful influence
- Update Design & Risk Inputs • Don’t wait for the final version to start aligning
- Integrate Into Product Roadmaps • Work with R&D, QA/RA, and exec sponsors • Flag projects needing early adaptation
- Engage the Right Experts • Join WGs or partner with someone who’s inside (👋) • Stay active – your input now shapes what becomes final
- Invest in Training • Get smart now to avoid surprises later
📎 Don’t wait for the FDIS – get involved now or get caught off guard later.
Need help with standards?
We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by
- Assisting with strategic compliance planning for your medical electrical product lines,
- Providing regulatory support when FDA or a regulator asks technical questions on your submission.
- Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
- Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
- We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
- Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
- Interfacing with test houses for medical safety, EMC and arrange other testing.
Feel free to schedule a web meeting with Leo or contact us.