Recognized standard
10993-4 Third edition 2017-04 [Including AMD1:2025]
FDA recognition 2-311 · ISO · Biocompatibility
Key facts
| Recognition number | 2-311 |
|---|---|
| Designation | 10993-4 Third edition 2017-04 [Including AMD1:2025] |
| Title | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the… |
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: