Recognized standard
10993-2 Third edition 2022-11
FDA recognition 2-300 · ISO · Biocompatibility
Key facts
| Recognition number | 2-300 |
|---|---|
| Designation | 10993-2 Third edition 2022-11 |
| Title | Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform… |
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: