Abstract:This paper briefly introduces the definition and classification of packaging for terminally sterilized medical devices, then conducts in-depth research and investigation on the development and supervision situation of the packing as well as relevant standards in domestic and overseas. Finally this paper expounds the problems found in the investigation, then puts forward some suggestions for better supervision and administration of the packaging.
刘毅,王会如,王峥崎,牛玉倩,张雨晨. 最终灭菌医疗器械包装的发展现状及监督管理调研[J]. 中国医疗设备, 2014, 29(11): 75-77.
LIU Yi, WANG Hui-ru, WANG Zheng-qi, NIU Yu-qian, ZHANG Yu-chen. Research on the Development and Supervision of Packaging for Terminally Sterilized Medical Devices. China Medical Devices, 2014, 29(11): 75-77.
ISO 11607-1:2006,Packaging for terminally sterilized medical devices-Part 1:Requirements for materials,sterile barrier systems and packaging systems[S].