Recognized standard
13408-3 First edition 2006-09-15 13408-3:2006/(R)2015
FDA recognition 14-239 · ISO · Sterility
Key facts
| Recognition number | 14-239 |
|---|---|
| Designation | 13408-3 First edition 2006-09-15 13408-3:2006/(R)2015 |
| Title | Aseptic processing of health care products - Part 3: Lyophilization |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 9, 2008 |
| Scope (excerpt) | ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process. |
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: