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包装

本类别共 7 条标准。

标准编号标题适用范围GSPR
ASTM F1980:2021Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesStandard guide for accelerated aging of sterile barrier systems and medical devi...11
ASTM D4169:2022Standard Practice for Performance Testing of Shipping Containers and SystemsStandard practice for performance testing of shipping containers and systems.11, 14
ASTM F2825:2010(R2020)Standard Practice for Climatic Stresses of Packaging and Contained ProductsStandard practice for climatic and durability exposures of adhesive joint assemb...11
ASTM D4332:2021Standard Practice for Conditioning Containers, Packages, or Packaging Components for TestingStandard practice for conditioning containers, packages, or packaging components...11
ASTM F2095:2007(R2020)Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining PlatesStandard test methods for pressure decay leak test for flexible packages with an...11
ISO 11607-1:2019Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systemsPackaging for terminally sterilized medical devices -- Requirements for material...11
ISO 11607-2:2019Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processesPackaging for terminally sterilized medical devices -- Validation requirements f...11

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