IEC 60601-1 (Edition 3.2 2020-08 (consolidated version))
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IECInternational standardElectrical safetyMedical devicesHigh confidenceLast verified October 4, 2026
The general safety standard for medical electrical equipment. It addresses all hazards, such as mechanical, electrical and radiation hazards.
The text of this standard is sold by IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Recognition by market
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|
| United States | Recognized | Edition 3.2 2020-08 (consolidated version) | - | Recognition number 19-49. Voluntary: a declaration of conformity to a recognized standard can be used in a submission.. Recognition number 19-49 was published as a new entry in Recognition List Number 060. Other editions may also be on the list; the database holds the full list. |
| European Union | Harmonized | EN 60601-1:2006 with amendment A13:2024 |
National standards based on it
- GB 9706.1-2020Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- JIS T 0601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (JIS version)
Testing requirements that cite it
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB 9706.1-2020, JIS T 0601-1, IEC 60601-2-83, IEC 60601-1-8, IEC 60601-1-11, ISO 14708-1, AS/NZS 3820, AS/NZS 3112, AS/NZS 4417.1, IEC 62133-2. See .
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
