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

Standard No.

GB/T 16886.4-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB/T 16886.4-2022

Replace

GB/T 16886.4-2003

Scope

This document specifies the general requirements for the evaluation of the interaction between medical devices and blood. This document gives: a) Classification of medical devices that come into contact with blood according to the intended use and contact time specified in ISO 10993 1; b) Basic evaluation principles for the interaction between devices and blood; c) According to the classification of specific devices, combined with the basic principles of testing and The scientific basis is the principle of selecting and combining the corresponding experiments. Due to the limited understanding of the interaction between the device and blood and the precision of the test, detailed test requirements cannot be specified. Therefore, this document only provides a general description of biological evaluation, and may not provide sufficient test method guidance for specific devices. . Changes to this document do not invalidate tests conducted in accordance with previous editions. For marketed devices with a history of safe clinical use, it is not recommended to conduct additional tests according to this revision.

GB/T 16886.4-2022 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

GB/T 16886.4-2022 history

• 2022 GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
• 2003 GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood

GB/T 16886.4-2022 -All Parts