Recognized standard
19238 Second edition 2014-02-01
FDA recognition 7-310 · ISO · InVitro Diagnostics
Key facts
| Recognition number | 7-310 |
|---|---|
| Designation | 19238 Second edition 2014-02-01 |
| Title | Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
| Standards developer | International Organization for Standardization |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | This International Standard provides criteria for quality assurance and quality control, evaluation of the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories. This International Standard addresses a) the confidentiality of personal information, for the… |
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: