质量控制图在医疗器械生物负载控制中的应用  

Application of Quality Control Chart in Bioburden Control of Medical Device

作　　者：李梦媛[1] 姜昊 沈以凌[1] 张悦[1] 

机构地区：[1]北京市射线应用研究中心,北京100015 [2]山东威高集团医用高分子制品股份有限公司,山东威海264210

出　　处：《中国医疗器械信息》2018年第1期3-5,共3页China Medical Device Information

摘　　要：文章利用控制图原理对医疗器械生物负载进行监控,介绍了控制图的基本概念,试列举了将均值-极差控制图应用于医疗器械生物负载监控的应用实例,为医疗器械企业利用控制图进行生物负载监测提供参考,为医疗器械企业提供了直观科学的质量管理办法,有助于企业及时发现生产过程中生物负载异常,降低企业风险,提高产品质量。The control chart is used to monitor the bioburden of medical devices. The paper introduced the basic concepts of the control chartand enumerated the use of X-R control chart in bioburden control of medical device. It provides reference for bioburden monitoring of medical device companies using control chart and provides an intuitive scientifc quality management approach to medical device companies. It helps enterprises to discover bioburden anomalies in production, reduce business risks and improve product quality.

关 键 词：控制图 医疗器械 生物负载 

分 类 号：R187[医药卫生—流行病学]