Recognized standard
10993-12 Fifth edition 2021-01 [Including AMD1:2025]
FDA recognition 2-314 · ISO · Biocompatibility
Key facts
| Recognition number | 2-314 |
|---|---|
| Designation | 10993-12 Fifth edition 2021-01 [Including AMD1:2025] |
| Title | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials [Including AMENDMENT 1 (2025)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | May 25, 2026 |
| Scope (excerpt) | This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this… |
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: