医疗器械生物相容性试验与GLP非临床数据质量管理  

Medical Device Biocompatibility Testing and GLP Non Clinical Data Quality Management

作　　者：屈秋锦 孙晓霞 乔春霞 林振华 盖潇潇 王国伟 朱褔余 孙令骁 QU Qiujin;SUN Xiaoxia;QIAO Chunxia;LIN Zhenhua;GAI Xiaoxiao;WANG Guowei;ZHU Fuyu;SUN Lingxiao(Department of Biological Evaluation,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China;NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Jinan Shandong 250101,China;Shandong Key Laboratory of Biological Evaluation for Medical Devices,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院生物学评价中心,山东济南250101 [2]国家药品监督管理局生物材料器械安全性评价重点实验室,山东济南250101 [3]山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《中国医疗设备》2024年第10期170-174,共5页China Medical Devices

基　　金：国家重点研发计划(2022YFC2409702);山东省医疗器械和药品包装检验研究院项目(NB202215)。

摘　　要：严格的GLP非临床数据质量管理能够有效降低医疗器械生物相容性试验数据的偏差,提高数据的真实性和完整性。在医疗器械生物相容性试验中采用GLP非临床数据质量管理,符合医疗器械安全性评价和风险管理要求,具有可行性和必要性。本文介绍了国内外符合良好实验室规范(Good Laboratory Practice,GLP)原则的医疗器械生物相容性试验开展情况和不同行业GLP的运行要求,从GLP原则出发阐述了GLP非临床数据质量管理在开展医疗器械生物相容性试验方面的关注要点。Through strict GLP non clinical data quality management,it is possible to effectively reduce the bias of medical device biocompatibility test data,and improve the authenticity and completeness of the data.It is feasible and necessary to use GLP non clinical data quality management in medical device biocompatibility test,which meets the requirements of medical device safety evaluation and risk management.The article introduced the implementation of biocompatibility testing for medical devices that comply with good laboratory practice(GLP)principles both domestically and internationally,as well as the operational requirements of GLP in different industries.Starting from GLP principles,it elaborated on the key points of GLP non clinical data quality management in conducting medical device biocompatibility testing.

关 键 词：医疗器械 生物材料 生物相容性 良好实验室规范 非临床数据质量管理 风险管理 可吸收支架 

分 类 号：R197.39[医药卫生—卫生事业管理]