Recognized standard
15882 Second edition 2008-09-01 15882:2008/(R)2013
FDA recognition 14-334 · ISO · Sterility
Key facts
| Recognition number | 14-334 |
|---|---|
| Designation | 15882 Second edition 2008-09-01 15882:2008/(R)2013 |
| Title | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results Sterilization of health care products - Chemical indicators - Guidance for 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 15882:2008 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. ISO 15882:2008 applies to indicators that show exposure to sterilization… |
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: