Recognized standard
14937 Second edition 2009-10-15 14937:2009/(R)2013
FDA recognition 14-337 · ISO · Sterility
Key facts
| Recognition number | 14-337 |
|---|---|
| Designation | 14937 Second edition 2009-10-15 14937:2009/(R)2013 |
| Title | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Sterilization of health care products - General requirements for characterization of a… |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | ISO 14937:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. It applies to sterilization processes in which microorganisms are inactivated by… |
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: