Medical devices - Application of usability engineering to medical devices
Sets the process for analyzing, specifying, designing, verifying and validating device usability, and for assessing risks caused by usability problems.
Listed as current. A new national usability standard based on IEC 62366-1 is in the approval stage.
The text of this standard is sold by China industry standard (YY) 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
No market listing is published yet.
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 62366-1, 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.