Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

2Scope / Description

This document deals with blood. It describes a) general requirements for the evaluation of interactions of medical devices with blood, which are intended to come into contact with blood and are classified according to intended use and duration of contact as defined in ISO 10993-1; b) the basic principles for therapeutic medical device interactions with blood; and c) the principles for the selection of structured tests according to specific categories, as well as the principles and scientific basis for these tests. Due to limited knowledge and precision in the evaluation of device interactions with blood, it is not possible to specify test requirements in detail. This document describes biological evaluations in general terms and does not necessarily provide adequate guidance on test approaches for specific devices. Changes to this document do not mean that tests performed according to the previous version are no longer recommended. Additional testing may be required when marketed devices have a history of use or clinical use.