Medical laboratories - Requirements for quality and competence
Requirements for the quality and competence of medical laboratories. In Australia, laboratories that make in-house IVDs are accredited to it by NATA.
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 |
|---|---|---|---|---|
| Australia | Referenced | - | - | Named in the medical device regulations for laboratories that make in-house IVDs. NATA accreditation to it is required. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: GB/T 42061-2022, YY/T 0287-2017, Q10, JIS Q 13485, ISO 13485. 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.