Recognized standard
10993-15 Second edition 2019-11
FDA recognition 2-288 · ISO · Biocompatibility
Key facts
| Recognition number | 2-288 |
|---|---|
| Designation | 10993-15 Second edition 2019-11 |
| Title | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use. This document is applicable only to those degradation products generated… |
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: