Recognized standard
F619-20
FDA recognition 2-283 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-283 |
|---|---|
| Designation | F619-20 |
| Title | Standard Practice for Extraction of Materials Used in Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining "extract liquid" for use in determining the biological response in preclinical testing. Further testing of the "extract liquid" is specified in… |
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: