Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
The general national standard for basic safety and essential performance of medical electrical equipment. Collateral standards (for example on electromagnetic compatibility) and particular standards for equipment types go with it.
Mandatory national standard, listed as current. It replaced GB 9706.1-2007 and GB 9706.15-2008.
The text of this standard is sold by China national standard and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
No market listing is published yet.
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 60601-1, 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.