Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Covers risk management for devices that use animal tissues and their derivatives.
The text of this standard is sold by ISO 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 |
|---|---|---|---|---|
| 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 | - |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: ISO 14971, GB/T 42062-2022, YY/T 0316-2016, Q9(R1), JIS T 14971, ISO 22442-2, ISO 22442-3. 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.
| - |
| Voluntary. The TGA accepts compliance with the standard for devices that use animal tissue. A different approach needs a showing of equal or higher safety. |