Brief Introduction of 10993-4:2017 Biological Evaluation of Medical Devices——Part 4: Selection of Tests for Interactions with Blood
HOU Li, QIAO Chunxia, ZHAO Zenglin
Shandong Provincial Inspection Center for Medical Devices/Key Lab of Biological Evaluation of Medical Devices of Shandong
Province, Jinan Shandong 250101, China
Abstract：Based on the practical application, the article introduced ISO 10993-4:2017, Biological evaluation of medical devices—
Part 4: Selection of tests for interactions with blood, and interpreted the selection of test classification and specific test methods of
the standard, which helped the user to better understand and apply the standard. Compared with the previous standard, the ISO10993-
4:2017 new standard content was richer in terms of availability and operability. Therefore, this standard will be of practical
significance to guide the evaluation of blood compatibility of medical devices in China.
侯丽，乔春霞，赵增琳. 解读ISO 10993-4:2017《医疗器械生物学评价第4部分：与血液相互作用试验选择》[J]. 中国医疗设备, 2018, 33(11): 1-6.
HOU Li, QIAO Chunxia, ZHAO Zenglin. Brief Introduction of 10993-4:2017 Biological Evaluation of Medical Devices——Part 4: Selection of Tests for Interactions with Blood. China Medical Devices, 2018, 33(11): 1-6.
