医用防护类产品生物学评价探讨  

Discussion on Biological Evaluation of Medical Protective Products

作　　者：张菁 孙彦鹤 田林奇 柳小军 杨伟芳 王海英 田靖 杨巧洋 ZHANG Jing;SUN Yan-he;TIAN Lin-qi;LIU Xiao-jun;YANG Wei-fang;WANG Hai-ying;TIAN Jing;YANG Qiao-yang(Henan Tuoren Medical Instrument Research Institute Co.,Ltd,Henan Xinxiang 453400;Henan Institute for Drug and Medical Device Inspection,Henan Zhengzhou 450000;NMPA Key Laboratory for Quality Evaluation of Medical Protective and Implant Devices,Henan Zhengzhou 450000)

机构地区：[1]河南驼人医疗器械研究院有限公司,河南新乡453400 [2]河南省药品医疗器械检验院,河南郑州450000 [3]国家药品监督管理局医用生物防护及植入器械质量评价重点实验室,河南郑州450000

出　　处：《中国医疗器械信息》2024年第1期12-14,96,共4页China Medical Device Information

摘　　要：通过对医用防护类产品的生物学评价国内外应用现状进行介绍,重点解读GB/T 16886.1-2022标准中生物学评价路线及其他新修订内容,梳理生物学评价路线及生物学评价中的注意事项。旨在帮助企业尤其是医用防护类产品选择适用的生物学评价路线,指导开展毒理学风险评定及完成生物学评价报告,为形成不同产品的生物学评价模式及生物学评价报告模板提供思路。By introducing the application status of biological evaluation of medical protective products at home and abroad,focusing on interpreting the biological evaluation route and other newly revised contents in GB/T 16886.1-2022,sorting out the biological evaluation route and precautions in biological evaluation,aiming to help enterprises,especially medical protective products,select the applicable biological evaluation route,guide the development of toxicological risk assessment and complete the biological evaluation report.Provide ideas for forming biological evaluation models and biological evaluation report templates of different products.

关 键 词：医疗器械 医用防护类产品 生物学评价 

分 类 号：F203[经济管理—国民经济] R197.39[医药卫生—卫生事业管理] TH77[医药卫生—公共卫生与预防医学]