Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
A collateral standard to IEC 60601-1. It sets requirements for medical electrical equipment and systems used in the home healthcare environment.
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.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United Kingdom | Recognized | EN 60601-1-11:2010 | - | Recognition number List row 216. Partial recognition. The list adds a note that the standard may not cover the requirements added to the Regulations in 2008, so manufacturers are advised to check that all relevant essential requirements are covered.. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
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, 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.