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SAMPLE COMPARE
IEC 60601-1
Medical electrical equipment — General requirements for basic safety and essential performance.
Ed. 3.1 · 2012 → Ed. 3.2 · 2020
Standards Library | IEC 60601-1 · Compare Editions ✦ ASK IRIS
EDITION 3.1
2005 + AMD1:2012
SUPERSEDED
EDITION 3.2
2005 + AMD1:2012 + AMD2:2020
CURRENT · FDA REQUIRED
CHANGE SUMMARY
What changed and when it became required
✦ IRIS · IMPACT ON YOUR QMS
Based on your documents in Syneris
§ 4.2 Risk management process MAJOR CHANGE
"A risk management process complying with ISO 14971:2007 shall be performed by the manufacturer."
"A risk management process complying with ISO 14971:2019 shall be performed by the manufacturer."
Updated normative reference from ISO 14971:2007 to ISO 14971:2019. Risk file structure, benefit-risk analysis, and post-production information feedback all expanded. FDA required: 17 Dec 2023.
Risk Management File RMF-0003 still references ISO 14971:2007. 3 risk control SOPs need updates to align with the 2019 benefit-risk methodology.
§ 8.7 Mains supply transients UPDATED
"Voltage transients applied to the supply mains. Test method per 8.7.4.1 only."
"Voltage transients applied to the supply mains. Test methods per 8.7.4.1 and 8.7.4.2, including ring-wave testing."
Expanded transient test methods. Adds ring-wave test alignment with IEC 61000-4-5 surge testing requirements. Affects design verification protocols.
DV protocol DVP-0019 only covers 8.7.4.1. Test plan needs amendment to add ring-wave verification before next release.
§ 14 Programmable Electrical Medical Systems (PEMS) MAJOR CHANGE
"Software lifecycle per IEC 62304:2006."
"Software lifecycle per IEC 62304:2006/AMD1:2015, with explicit requirements for legacy software and SOUP."
Aligned with IEC 62304 Amendment 1. New requirements for legacy software qualification and SOUP (Software of Unknown Provenance) handling.
2 SOPs for software lifecycle don't yet address SOUP qualification. DHF for Device-A02 uses 2 SOUP libraries that need formal qualification records.
✦ IRIS · TRANSITION SUMMARY 12 clauses changed · 8 affect your QMS
Across the Edition 3.1 → 3.2 transition, 8 changes affect your active QMS: 1 risk file, 5 SOPs, 1 DV protocol, and 1 DHF. FDA mandatory date: 17 Dec 2023.
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