Recognized standard
/TS 20914 First edition 2019-07
FDA recognition 7-297 · ISO · InVitro Diagnostics
Key facts
| Recognition number | 7-297 |
|---|---|
| Designation | /TS 20914 First edition 2019-07 |
| Title | Medical laboratories - Practical guidance for the estimation of measurement uncertainty |
| Standards developer | International Organization for Standardization |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also… |
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: