Recognized standard
F750-20
FDA recognition 2-279 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-279 |
|---|---|
| Designation | F750-20 |
| Title | Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices. 1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human… |
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: