Recognized standard
13408-1 Third edition 2023-08
FDA recognition 14-592 · ISO · Sterility
Key facts
| Recognition number | 14-592 |
|---|---|
| Designation | 13408-1 Third edition 2023-08 |
| Title | Aseptic processing of health care products - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic… |
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: