Recognized standard
F2382-18
FDA recognition 2-266 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-266 |
|---|---|
| Designation | F2382-18 |
| Title | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per… |
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: