Recognized standard
ST72:2019
FDA recognition 14-541 · ANSI · Sterility
Key facts
| Recognition number | 14-541 |
|---|---|
| Designation | ST72:2019 |
| Title | Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. NOTE… |
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: