Recognized standard
F1984-99 (Reapproved 2018)
FDA recognition 2-141 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-141 |
|---|---|
| Designation | F1984-99 (Reapproved 2018) |
| Title | Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | 1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro whole complement activating properties of… |
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: