At a glance
- Short name
- IEC 62366-1
- Jurisdiction
- International
- Also known as / related labels
- IEC 62366-1:2015+AMD1:2020 · ISO 14971 · FDA HFE Guidance · IEC TR 62366-2:2016
What this entry covers
IEC 62366-1, published by the International Electrotechnical Commission (IEC), specifies a usability engineering process for manufacturers to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. It applies to medical device manufacturers. The current version is the 2015 first edition with Amendment 1 (2020), available as a consolidated version.
MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid. It is not legal advice and is not a substitute for the official text.
Official documentation
- Primary official source: https://webstore.iec.ch/en/publication/67220
- ISO catalogue page: https://www.iso.org/standard/63179.html
How to use this index entry
- Open the official link above (or the agency home if the deep link drifts).
- Confirm edition / revision date against your program scope.
- Map applicability by sector and jurisdiction listed in the metadata.
- Follow related frameworks only after checking their own official sources.
Disclaimers
- MyRHC does not host proprietary standards text (ISO, some industry bodies).
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- Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice.
MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.