Recognized standard
13408-1 Second edition 2008-06-15
FDA recognition 14-427 · ISO · Sterility
Key facts
| Recognition number | 14-427 |
|---|---|
| Designation | 13408-1 Second edition 2008-06-15 |
| Title | Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance… |
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: