Recognized standard
10993-23 First edition 2021-01
FDA recognition 2-291 · ISO · Biocompatibility
Key facts
| Recognition number | 2-291 |
|---|---|
| Designation | 10993-23 First edition 2021-01 |
| Title | Biological evaluation of medical devices - Part 23: Tests for irritation |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jun 7, 2021 |
| Scope (excerpt) | This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO… |
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: