Evaluation of Qualitative, Binary Output Examination Performance
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 7-315. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| 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. |
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 EP19, 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.