Recognized standard
10993-13 Second edition 2010-06-15 10993-13:2010/(R)2014
FDA recognition 2-169 · ISO · Biocompatibility
Key facts
| Recognition number | 2-169 |
|---|---|
| Designation | 10993-13 Second edition 2010-06-15 10993-13:2010/(R)2014 |
| Title | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation… |
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: