Recognized standard
13408-7 First edition 2012-08-01 13408-7:2012 (R2018)
FDA recognition 14-388 · ISO · Sterility
Key facts
| Recognition number | 14-388 |
|---|---|
| Designation | 13408-7 First edition 2012-08-01 13408-7:2012 (R2018) |
| Title | Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to 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: