Recognized standard
11737-1 Third edition 2018-01 [Including AMD1:2021]
FDA recognition 14-577 · ISO · Sterility
Key facts
| Recognition number | 14-577 |
|---|---|
| Designation | 11737-1 Third edition 2018-01 [Including AMD1:2021] |
| Title | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on… |
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: