Recognized standard
10993-10 Fourth edition 2021-11
FDA recognition 2-296 · ISO · Biocompatibility
Key facts
| Recognition number | 2-296 |
|---|---|
| Designation | 10993-10 Fourth edition 2021-11 |
| Title | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: - details of in vivo skin sensitization test procedures; - key factors for the interpretation 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: