摘要
介绍了一次性使用无菌手术膜的相关标准现状和注册情况,阐述了2017—2023年间4次一次性使用无菌手术膜国家医疗器械监督抽检情况并分析了监督抽检中发现的不合格项目,总结了开展的探索性研究项目,指出了抽检中发现的其他问题,提出了企业应加强对行业标准的贯彻执行力度,认真对待产品材质标识信息,明确限定所用原材料、规范产品注册名称等建议,为手术膜行业的监管与发展提供了参考。
The existing relevant standards and registration of disposable sterile surgical drapes were introduced,and four times of national supervision and sample inspection of disposable sterile surgical drapes from 2017 to 2023 were described.The unqualified items found in the supervision and sample inspection were analyzed,the exploratory research projects carried out were summarized and other problems encountered during the sample inspection were pointed out.Relevant enterprises were suggested to strengthen the implementation of industry standards,take seriously the product material identification information,clearly limit the raw materials used and standardize the product registration name.References were provided for the industrial supervision and development of disposable sterile surgical drapes.
作者
孙钰朋
李庆雨
李帆
林则晨
刘学冲
张博
SUN Yu-peng;LI Qing-yu;LI Fan;LIN Ze-chen;LIU Xue-chong;ZHANG Bo(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,National Medical Products Administration Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,Jinan 250101,China)
出处
《医疗卫生装备》
2025年第5期66-72,共7页
Chinese Medical Equipment Journal
基金
山东省药品监督管理局2024年重点实验室检验检测能力提升项目(SDNMPAFZLX202401)。
关键词
一次性使用无菌手术膜
国家监督抽检
医疗器械
disposable sterile surgical drape
national supervision and sample inspection
medical device
