+1 888 608-7511
Need help finding a standard?
Help Desk
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.
It describes:
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.
Failed to load document history.
| Publish Date | Document Id | Type | View |
|---|