YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods
YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods
Basic Information
Scope
This document specifies the requirements and test methods for sealable composite bags and rolls made of breathable materials that comply with YY/T 0698.2, 0698.3, 0698.6, 0698.7, or 0698.9, or plastic films that comply with the provisions of Chapter 4 of this document. These sealable composite bags and rolls can be used as sterile barrier systems and/or packaging systems to ensure the sterility of the final sterilized medical devices until they are used. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this document specifies the special requirements and test methods for the materials covered in this section. This document is only applicable to packaging materials for single-use, final sterilized medical devices.