医疗卫生装备2025，Vol.46Issue(5)：66-72,7.DOI:10.19745/j.1003-8868.2025089
一次性使用无菌手术膜国家监督抽检情况分析
Analysis on national supervision and sample inspection of disposable sterile surgical drapes
摘要
Abstract
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.[Chinese Medical Equipment Journal,2025,46(5):66-72]关键词
一次性使用无菌手术膜/国家监督抽检/医疗器械Key words
disposable sterile surgical drape/national supervision and sample inspection/medical device分类
医药卫生引用本文复制引用
孙钰朋,李庆雨,李帆,林则晨,刘学冲,张博..一次性使用无菌手术膜国家监督抽检情况分析[J].医疗卫生装备,2025,46(5):66-72,7.基金项目
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) （SDNMPAFZLX202401）
