Recognized standard
10993-2 Second edition 2006-07-15 10993-2:2006/(R)2014
FDA recognition 2-222 · ISO · Biocompatibility
Key facts
| Recognition number | 2-222 |
|---|---|
| Designation | 10993-2 Second edition 2006-07-15 10993-2:2006/(R)2014 |
| Title | Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be… |
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: