Recognized standard
10993-1 Sixth edition 2025-11
FDA recognition 2-313 · ISO · Biocompatibility
Key facts
| Recognition number | 2-313 |
|---|---|
| Designation | 10993-1 Sixth edition 2025-11 |
| Title | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | May 25, 2026 |
| Scope (excerpt) | This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with… |
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: