A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
The text of this standard is sold by CLSI 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 |
|---|---|---|---|---|
| United States | Recognized | 3rd Edition | - | Recognition number 7-323. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| Australia | Referenced | 2nd edition (2015) | - | Voluntary. Listed by the TGA as relevant to clinical evidence for IVDs. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: CLSI EP06, CLSI EP07, CLSI EP09c, CLSI EP12, CLSI EP21, CLSI EP25, CLSI EP35, ISO 17511, ISO 20916, NPAAC in-house IVD standard, CLSI EP05, CLSI EP14. See .
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.