Recognized standard
10993-9 Third edition 2019-11
FDA recognition 2-273 · ISO · Biocompatibility
Key facts
| Recognition number | 2-273 |
|---|---|
| Designation | 10993-9 Third edition 2019-11 |
| Title | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in 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: