Recognized standard
10993-10 Third Edition 2010-08-01 10993-10:2010/(R)2014
FDA recognition 2-174 · ISO · Biocompatibility
Key facts
| Recognition number | 2-174 |
|---|---|
| Designation | 10993-10 Third Edition 2010-08-01 10993-10:2010/(R)2014 |
| Title | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and 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: