AAMI/ISO 11607-2:2019-最终灭菌医疗器械的包装.第2部分:成型、密封和组装工艺的验证要求-国家数字标准馆

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes 最终灭菌医疗器械的包装.第2部分:成型、密封和组装工艺的验证要求

                规定了最终灭菌并保持无菌至使用点的医疗器械包装工艺的开发和验证要求。这些过程包括预制无菌屏障系统、无菌屏障系统和包装系统的成型、密封和组装。

Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.

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发布单位或类别：美国-美国医疗器械促进协会

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相似标准/计划/法规

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SN/T 3062.4-2011

进口医疗器械灭菌包装第4部分：材料和预成型无菌屏障系统要求
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최종 멸균 처리한 의료기기의 포장 — 제1부: 재료, 무균 장벽 시스템 및 포장 시스템에 대한 요구사항
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用于终端灭菌医疗器械的包装 - 第1部分:材料无菌屏障系统和包装系统的要求

AAMI/ISO 11607-1-2019

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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
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-1-2019

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
用于终端灭菌医疗器械的包装 - 第1部分:材料无菌屏障系统和包装系统的要求

KS P ISO 11607-2

최종 멸균 처리한 의료기기의 포장 —제2부: 성형, 봉함 및 조립 공정에 대한 유효성 확인 요구사항
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KS P ISO 11607-2

최종 멸균 처리한 의료기기의 포장 — 제2부: 성형, 봉함 및 조립 공정에 대한 유효성 확인 요구사항
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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
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SN/T 3062.2-2011

进口医疗器械灭菌包装第2部分：纸袋-要求和试验方法
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BS PD CEN ISO/TS 16775-2021

Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
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UNE-EN 868-4-2009

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UNE-EN 868-6-2009

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YY/T 0698.8-2009

最终灭菌医疗器械包装材料　第8部分：蒸汽灭菌器用重复性使用灭菌容器　要求和试验方法
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UNE-EN ISO 11607-1-2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
最终灭菌医疗器械的包装.第1部分:材料、无菌屏障系统和包装系统的要求（ISO 11607-1-2006）

UNE-EN ISO 11607-2-2007

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
最终灭菌医疗器械的包装第2部分:成型、密封和组装工艺的验证要求

《国家标准化发展纲要》提出建设国家数字标准馆，推动标准化工作向数字化、网络化、智能化转型。中国标准化研究院正在全力推进国家数字标准馆建设，力争在2026年底建成“一个中心”和“一个平台”，即全球领先的标准数据资源中心，涵盖标准全生命周期的数字化、网络化、智能化研究与服务平台。

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