Medical devices - Application of risk management to medical devices (JIS version)
terms, principles and the process of risk management for medical devices, including software and in vitro diagnostic devices. Identical adoption of the international standard.
The text of this standard is sold by Japanese Industrial Standards Committee 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: ISO 14971, GB/T 42062-2022, YY/T 0316-2016, Q9(R1), ISO 22442-1, 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.