Recognized standard
10993-11 Third edition 2017-09 10993-11: 2017
FDA recognition 2-255 · ISO · Biocompatibility
Key facts
| Recognition number | 2-255 |
|---|---|
| Designation | 10993-11 Third edition 2017-09 10993-11: 2017 |
| Title | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. |
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: