Recognized standard
10993-14 First edition 2001-11-15 10993-14:2001/(R) 2011
FDA recognition 2-170 · ISO · Biocompatibility
Key facts
| Recognition number | 2-170 |
|---|---|
| Designation | 10993-14 First edition 2001-11-15 10993-14:2001/(R) 2011 |
| Title | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature… |
At a glance
- 1–9 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: