医疗器械生产企业洁净厂房检测质量影响因素研究  

Study on Influencing Factors of Environmental Testing Quality of Medical Device Manufacturers Clean Workshops

作　　者：梁谋[1,2,3] 宣泽 庞逸辉[1,2,3] 王霞 刘欢 江志杰 LIANG Mou;XUAN Ze;PANG Yihui;WANG Xia;LIU Huan;JIANG Zhijie(Beijing Institute for Drug Control,Beijing,102206;NMPA Key Lab.of Research and Evaluation of Generic Drugs,Beijing,102206;Beijing Key Lab.of Analysis and Evaluation on Chinese Medicine,Beijing,102206)

机构地区：[1]北京市药品检验所,北京市102206 [2]国家药品监督管理局仿制药研究与评价重点实验室,北京市102206 [3]北京市中药成分分析与生物评价重点实验室,北京市102206

出　　处：《中国医疗器械杂志》2022年第1期99-102,113,共5页Chinese Journal of Medical Instrumentation

摘　　要：目的提高医疗器械生产企业洁净厂房检测工作质量,保证检测数据真实可靠。方法分析2016年—2020年医疗器械生产企业洁净厂房检测过程中发现的问题和存在的影响因素,并对保证检测工作质量提出合理化的建议。结果在检测过程中检测人员、仪器设备、检测耗材、检测方法、检测环境、检测实际操作6个方面存在影响检测质量的因素。结论提高检测工作质量,应当加强检测人员培训,持续改进完善检测质量管理体系,建立有效的信息沟通机制,及时发现影响因素,为医疗器械生产企业提供客观、真实、有效的检测数据,更好地为医疗器械的生产和监管提供技术支撑。Objective Improve the quality of testing in medical device manufacturers clean workshops to ensure the authenticity and reliability of testing data.Methods Analyze the problems and influencing factors found in the process of testing of medical device manufacturers clean workshops from 2016 to 2020,and put forward reasonable suggestions to ensure the quality of testing.Results In the process of testing,there are six factors that affect the quality of testing,including testing personnel,instruments and equipment,testing consumables,testing methods,testing environment and actual operation.Conclusion To improve the quality of testing,should strengthen the training of testing personnel,continuously improve the testing quality management system,establish an effective information communication mechanism,find out the influencing factors in time,provide objective,real and effective testing data for medical device manufacturing enterprises,and provide technical support for the production and supervision of medical devices.

关 键 词：医疗器械 洁净厂房 质量控制 影响因素值 

分 类 号：F203[经济管理—国民经济]