Recognized standard
F1904-23
FDA recognition 2-299 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-299 |
|---|---|
| Designation | F1904-23 |
| Title | Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | 1.1 The purpose of this standard guide is to describe the principles and approaches to testing of medical device debris and degradation products from device materials (for example, particles from wear) for their potential to activate a cascade of biological responses at local and systemic levels 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: