Recognized standard
22441 First edition 2022-08
FDA recognition 14-586 · ISO · Sterility
Key facts
| Recognition number | 14-586 |
|---|---|
| Designation | 22441 First edition 2022-08 |
| Title | Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | 1.1 Inclusions 1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent. 1.1.2 This document is intended to be applied… |
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: