Recognized standard
F1980-16
FDA recognition 14-497 · ASTM · Sterility
Key facts
| Recognition number | 14-497 |
|---|---|
| Designation | F1980-16 |
| Title | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607-1:2006 and the physical properties of their component… |
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: