Recognized standard
17099 First edition 2014-11-15
FDA recognition 7-309 · ISO · InVitro Diagnostics
Key facts
| Recognition number | 7-309 |
|---|---|
| Designation | 17099 First edition 2014-11-15 |
| Title | Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
| Standards developer | International Organization for Standardization |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | This International Standard addresses the following: a) confidentiality of personal information for the customer and the laboratory; b) laboratory safety requirements; c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the dose… |
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: