Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Collateral standard on usability of medical electrical equipment.
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 60601-1-6:2010 | - | Recognition number List row 213. 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. |
| Japan | Adopted |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 62366-1, YY/T 1474-2016, JIS T 60601-1-6, JIS T 62366-1. See all standards.
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.
| IEC 60601-1-6:2010 with amendments 1 (2013) and 2 (2020), identical JIS version |
| JIS T 60601-1-6:2023医用電気機器―第１－６部：基礎安全及び基本性能に関する一般要求事項―副通則：ユーザビリティ |
| The usability Q&A names the JIS version as an example of another standard that may be used to meet the usability Essential Principles. |
| 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. |