Standard Number: YY/T 0698.5-2023(YY/T0698.5-2023)
Chinese: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
English:Packaging materials for terminal sterilized medical devices-Part 5:Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods
Effective Date:2024-09-15
ICS:11.080.040
Standard Applicability:This document specifies requirements and test methods for sealable combination pouches and rolls consisting of air permeable materials in accordance with parts YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and plastic films in accordance with clause 4 of this document. These sealable pouches and rolls can be used as sterile barrier systems and/or packaging systems to ensure the sterility of the final sterilized medical device to the point of use. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this document specifies requirements and test methods specific to the materials covered by this part. This document only applies to single-use final sterilization medical device packaging materials.
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