Recognized standard
14161 Second edition 2009-09-15 14161-2009/(R)2014
FDA recognition 14-336 · ISO · Sterility
Key facts
| Recognition number | 14-336 |
|---|---|
| Designation | 14161 Second edition 2009-09-15 14161-2009/(R)2014 |
| Title | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. ISO 14161:2009 applies to biological indicators for which International… |
At a glance
- 1–9 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: