Medical devices - Part 1: Application of usability engineering to medical devices
Describes how usability engineering is applied to medical device design, with attention to risk management.
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 States | Recognized | Edition 1.1 2020-06 (consolidated version) | - | Recognition number 5-129. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| United Kingdom | Recognized | EN 62366-1:2015 with amendment A1:2020 | - | Recognition number List row 271. 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: YY/T 1474-2016, JIS T 60601-1-6, JIS T 62366-1, IEC 60601-1-6. 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.
| Japan | Adopted | IEC 62366-1:2015 with amendment 1 (2020), identical JIS version | JIS T 62366-1:2022医療機器―第１部：ユーザビリティエンジニアリングの医療機器への適用 | Transition until March 31, 2024. Essential Principles Articles 9 and 16 and related articles call for application of the 2022 JIS edition. |
| China | Not recognized | - | YY/T 1474-2016Medical devices - Application of usability engineering to medical devices | The adopted national version of IEC 62366-1 is not yet issued, so the older YY/T 1474-2016 remains the listed national standard.. Recommended industry standard on usability engineering. A national standard identical to IEC 62366-1 is still in the approval stage. |
| 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. |
| Australia | Referenced | - | - | Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. |