Recognized standard
17665 First edition 2024-03
FDA recognition 14-601 · ISO · Sterility
Key facts
| Recognition number | 14-601 |
|---|---|
| Designation | 17665 First edition 2024-03 |
| Title | Sterilization of health care products - Moist heat - 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, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: