Recognized standard
18472 Second edition 2018-08
FDA recognition 14-544 · ISO · Sterility
Key facts
| Recognition number | 14-544 |
|---|---|
| Designation | 18472 Second edition 2018-08 |
| Title | Sterilization of health care products - Biological and chemical indicators - Test equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This document specifies the requirements for test equipment to be used to: - test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; - test chemical indicators for steam, ethylene oxide gas, dry heat… |
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: