GB/T 19633.1-2015 最终灭菌医疗器械包装 第1部分:材料、无菌屏障系统和包装系统的要求
ISO 11607-1:2006 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.2-2015 最终灭菌医疗器械包装 第2部分:成形、密封和装配过程的确认的要求
ISO 11607-2:2006 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes