Recognized standard
10993-12 Fourth edition 2012-07-01 10993-12:2012
FDA recognition 2-191 · ISO · Biocompatibility
Key facts
| Recognition number | 2-191 |
|---|---|
| Designation | 10993-12 Fourth edition 2012-07-01 10993-12:2012 |
| Title | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO… |
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: