Standard No.:	YY/T 0698.5-2023
English Name:	Packaging materials for terminal sterilized medical devices―Part 5:Sealable pouches and reels of porous materials and plastic film construction―Requirements and test methods
Chinese Name:	最终灭菌医疗器械包装材料 第5部分：透气材料与塑料膜组成的可密封组合袋和卷材 要求和试验方法
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	National Medical Products Adminstration
Issued on:	2023-09-05
Implemented on:	2024-9-15
Status:	valid
Superseding:	YY/T 0698.5-2009 Packaging materials for terminal sterilized medical devices—Part 5:Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods
Language:	English
File Format:	PDF
Word Count:	8500 words
Price(USD):	255.0
Delivery:	via email in 1~3 business day

本文件规定了符合YY/T 0698.2、0698.3、0698.6、0698.7、0698.9或0698.10部分透气材料和符合本文件条款4规定的塑料膜组成的可密封组合袋和卷材的要求和试验方法。
这些可密封组合袋和卷材可用作无菌屏障系统和/或包装系统，以保证最终灭菌医疗器械到使用时的无菌性。
除GB/T 19633.1和GB/T 19633.2规定的通用要求外，本文件规定了本部分涵盖的材料的专用要求和试验方法。
本文件仅适用于一次性使用的最终灭菌医疗器械包装材料。