Recognized standard
13408-2 Second edition 2018-01 13408-2:2018
FDA recognition 14-512 · ISO · Sterility
Key facts
| Recognition number | 14-512 |
|---|---|
| Designation | 13408-2 Second edition 2018-01 13408-2:2018 |
| Title | Aseptic processing of health care products - Part 2: Sterilizing filtration. Aseptic processing of health care products - Part 2:Sterilizing filtration |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing… |
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: