Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A collateral standard to IEC 60601-1. It sets general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
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 60601-1-8:2007 with AC:2010 and A11:2017 | - | Recognition number List row 214. 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 60601-1-11, 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.