Recognized standard
11137-1 First edition 2006-04-15 11137-1:2006/(R)2015
FDA recognition 14-528 · ISO · Sterility
Key facts
| Recognition number | 14-528 |
|---|---|
| Designation | 11137-1 First edition 2006-04-15 11137-1:2006/(R)2015 |
| Title | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] Sterilization of health care products - Radiation - Part 1: Requirements for… |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other… |
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: