IEC 62366 vs IEC 81001-5-1
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-62366-vs-iec-81001
COMPARE
vs
7IEC 62366 REQUIREMENTS
0SHARED IN BOTH
7NEW IN IEC 62366
46RETIRED FROM IEC 81001
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 62366IEC 81001-5-1
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2015 – present (Amd 1:2020)2021 – present
Total requirements746
SCOPE
Risk integrationUse-error risks via ISO 14971Cybersecurity risks via ISO 14971
Plan maintenanceUsability Engineering File maintained throughout device lifecycleSecurity Development Life Cycle Plan from conception through decommissioning
Document approvalUsability Evaluation Plan and Report require documented approvalMulti-disciplinary security requirements review; pre-release verification checklist
OPERATIONAL
Most common gapUsability engineering disconnected from risk management fileSecurity risk management siloed from safety risk management
Audit focusUsability File completeness, use scenario traceability, summative coverageThreat model integrity, security-safety integration, penetration test scope
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
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
46ONLY IN IEC 81001
- • QMS and Security Responsibilities
- • Identification of Applicability
- • Security Expertise and Training
- • Third-Party Supplier Security
- • Continuous Improvement and Periodic Review
- • Disclosing Security-Related Issues
- + 40 more
OTHER COMPARISONS