Recognized standard
11737-3 First Edition 2023-06
FDA recognition 14-604 · ISO · Sterility
Key facts
| Recognition number | 14-604 |
|---|---|
| Designation | 11737-3 First Edition 2023-06 |
| Title | Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 9, 2024 |
| Scope (excerpt) | 1.1 Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. 1.2 Exclusions 1.2.1 This document is not… |
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: