Recognized standard
F2901-19
FDA recognition 2-265 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-265 |
|---|---|
| Designation | F2901-19 |
| Title | Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with… |
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: