Recognized standard
11137-1 Second edition 2025-04
FDA recognition 14-611 · ISO · Sterility
Key facts
| Recognition number | 14-611 |
|---|---|
| Designation | 11137-1 Second edition 2025-04 |
| Title | Sterilization of health care products - Radiation - Part 1: 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 26, 2025 |
| Scope (excerpt) | 1.1. This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment. This document covers… |
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: