Recognized standard
F997-18
FDA recognition 8-510 · ASTM · Materials
Key facts
| Recognition number | 8-510 |
|---|---|
| Designation | F997-18 |
| Title | Standard Specification for Polycarbonate Resin for Medical Applications |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing… |
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: