Health software - Part 1: General requirements for product safety
Sets general product safety requirements for health software.
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 |
|---|---|---|---|---|
| European Union | Referenced | - | - | Named for information in EU cybersecurity guidance. It gives no presumption of conformity unless the standard is harmonised and published in the Official Journal. |
| Australia | Referenced | - | - | Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 62304, YY/T 0664-2020, GB/T 25000.51-2016, JIS T 2304, IMDRF GMLP guiding principles. 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.