Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Canadian national standard on basic safety and essential performance of medical electrical equipment. The list gives it the same title as IEC 60601-1.
The text of this standard is sold by CSA Group 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
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB 9706.1-2020, 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. 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.