Recognized standard
11737-2 Third edition 2019-12 11737-2:2019
FDA recognition 14-540 · ISO · Sterility
Key facts
| Recognition number | 14-540 |
|---|---|
| Designation | 11737-2 Third edition 2019-12 11737-2:2019 |
| Title | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed… |
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: