IEC 62366 vs ISO 14971
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-iso-14971
COMPARE
vs
14IEC 62366 REQUIREMENTS
4SHARED IN BOTH
10NEW IN IEC 62366
9RETIRED FROM ISO 14971
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 62366ISO 14971
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2015 – present (Amd 1:2020)2019 – present
Total requirements149
SCOPE
Risk integrationUse-error risks via ISO 14971Defines the framework
Plan maintenanceUsability Engineering File maintained throughout device lifecycleRisk Management Plan updated through post-production phases
Document approvalUsability Evaluation Plan and Report require documented approvalRisk Management Plan and Report require formal approval before release
OPERATIONAL
Most common gapUsability engineering disconnected from risk management fileRisk file created post-design; not updated after field actions
Audit focusUsability File completeness, use scenario traceability, summative coverageRisk file integrity, control hierarchy rationale, post-market feedback loop
COVERAGE BREAKDOWN
What's shared, what's distinct
4SHARED IN BOTH
- • RISK CONTROL as it relates to USER INTERFACE design
- • Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
- • Identify and describe HAZARD-RELATED USE SCENARIOS
- • Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
10ONLY 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
- + 4 more
9ONLY IN ISO 14971
- • Risk Management Process
- • Risk Management Plan
- • Intended Use and Reasonably Foreseeable Misuse
- • Hazard Identification and Risk Estimation
- • Risk Evaluation Against Acceptability Criteria
- • Risk Control Option Analysis
- + 3 more
OTHER COMPARISONS