Recognized standard
F2475-20
FDA recognition 14-539 · ASTM · Sterility
Key facts
| Recognition number | 14-539 |
|---|---|
| Designation | F2475-20 |
| Title | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or indirectly. 1.2 This guide does not apply to secondary or tertiary packaging materials. 1.3 This standard… |
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: