GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

Scope

This document specifies the general requirements for the evaluation of the interaction between medical devices and blood.
This document provides:
a) Classification of medical devices that come into contact with blood according to the intended use and contact time specified in ISO 109931;
b) Basic evaluation principles for the interaction between devices and blood;
c) Principles for selecting a combination of corresponding tests based on the specific device classification, combined with the basic principles of the test and scientific basis.
Due to the limitations of our understanding of the interaction between devices and blood and the precision of the tests, detailed test requirements cannot be specified. Therefore, this document only provides a general description of biological evaluation and may not provide sufficient guidance on test methods for specific devices.
Changes to this document do not imply that tests conducted according to previous versions are invalid. For marketed devices with a history of safe clinical use, it is not recommended to conduct additional tests according to this revision.

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