IEC 62304 vs IEC 62366
What's actually different between the QMS regulations medical device manufacturers must follow — clause-by-clause comparison from the Kelsey Quality crosswalk library.
kelseyqms.com/crosswalk/compare/iec-62304-vs-iec-62366
COMPARE
vs
11IEC 62304 REQUIREMENTS
0SHARED IN BOTH
11NEW IN IEC 62304
7RETIRED FROM IEC 62366
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 62304IEC 62366
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2006 – present (Amd 1:2015)2015 – present (Amd 1:2020)
Total requirements117
SCOPE
Risk integrationSoftware-specific risk via ISO 14971; class drives requirement depthUse-error risk linked bidirectionally to ISO 14971 risk file
Plan maintenanceSoftware development plan updated throughout lifecycleUsability evaluation plan maintained through device lifecycle
Document approvalFormal verification records required per class and phaseUsability engineering file with traceable evaluation records
OPERATIONAL
Most common gapInternal software controls used to lower safety classificationUsability engineering disconnected from risk management file
Audit focusClassification rationale, SOUP list currency, plan update recordsUse-error to hazard traceability, summative evaluation completeness
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
11ONLY IN IEC 62304
- • Software Safety Classification
- • Software Development Planning
- • Software Requirements Analysis
- • Software Architectural Design
- • Software unit implementation
- • Software System Testing
- + 5 more
7ONLY IN IEC 62366
- • Usability Engineering Process
- • Usability Engineering File
- • Use Specification
- • Identify known or foreseeable Hazards and Hazardous Situations
- • Establish User Interface Evaluation plan
- • Perform Summative Evaluation of the Usability of the User Interface
- + 1 more
OTHER COMPARISONS