Recognized standard
10993-17 Second edition 2023-09
FDA recognition 2-303 · ISO · Biocompatibility
Key facts
| Recognition number | 2-303 |
|---|---|
| Designation | 10993-17 Second edition 2023-09 |
| Title | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the… |
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: