Recognized standard
11140-5 Second edition 2007-03-15 11140-5:2007/(R)2012
FDA recognition 14-332 · ISO · Sterility
Key facts
| Recognition number | 14-332 |
|---|---|
| Designation | 11140-5 Second edition 2007-03-15 11140-5:2007/(R)2012 |
| Title | Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 11140-5:2007 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, ISO 11140-5:2007 includes test methods and equipment used… |
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: