Recognized standard
13408-5 First edition 2006-11-15 13408-5:2006/(R)2015
FDA recognition 14-240 · ISO · Sterility
Key facts
| Recognition number | 14-240 |
|---|---|
| Designation | 13408-5 First edition 2006-11-15 13408-5:2006/(R)2015 |
| Title | Aseptic processing of health care products - Part 5: Sterilization-in-place Aseptic processing of health care products - Part 5: Sterilization in place |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 9, 2008 |
| Scope (excerpt) | ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO… |
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: