Objective: To understand the development of international medical device biocompatibility testing and provide references for better biocompatibility evaluation. Methods: By consulting international standards and regulations such as ISO 10993, the key changes in the biological evaluation of medical devices and the corresponding changes in FDA evaluation guidelines were summarized. The updated standards in ISO 10993 related to material chemical characterization, physical characterization, and tests for irritation were introduced. Results and Conclusion: The update of international medical device biocompatibility standards and regulations aims to determine whether to conduct relevant experiments through biological evaluation indicators (such as material, physical/chemical characterization, etc.), thereby reducing the use of experimental animals. This provides a reference for the improvement of the relevant regulatory documents for medical devices in China.
Sun Yanyan, Wang Han, Chen Dandan, Li Bo
. Update of International Standards and Regulations for Biocompatibility Testing of Medical Devices[J]. Chinese Pharmaceutical Affairs, 2024
, 38(2)
: 152
-159
.
DOI: 10.16153/j.1002-7777.2024.02.005
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