Recognized standard
17511 Second edition 2020-04
FDA recognition 7-305 · ISO · InVitro Diagnostics
Key facts
| Recognition number | 7-305 |
|---|---|
| Designation | 17511 Second edition 2020-04 |
| Title | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| Standards developer | International Organization for Standardization |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: