Recognized standard
10993-4 Third edition 2017-04 10993-4: 2017
FDA recognition 2-248 · ISO · Biocompatibility
Key facts
| Recognition number | 2-248 |
|---|---|
| Designation | 10993-4 Third edition 2017-04 10993-4: 2017 |
| Title | Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Aug 21, 2017 |
| 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: