ISO/DIS 23417:1975 良好分销实践原则中非菌医疗器械包装的通用规范和验证方法
General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
21/30384564 DC BS ISO 23417 良好分销实践原则中非菌医疗器械包装的通用规范和验证方法
BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
KS T 5011-2020 包装.医疗器械运输包装的试验方法
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
DIN 96042:2006 医疗器械. 包装. 技术规范
Medical instruments - Packaging - Technical specification
T/SHBX 005-2023 《可灭菌医疗器械包装膜》
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
GB/T 19633-2005 最终灭菌医疗器械的包装
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
SN/T 3061-2011 进口医疗器械灭菌包装检验操作规程
Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices
BS EN ISO 11607-2:2020+A11:2022 最终灭菌医疗器械的包装 成型、密封和组装过程的验证要求
1 Scope This document specifies requirements for the development and validation of processes for packaging medical devices
Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN ISO 11607-2:2020+A1:2023 最终灭菌医疗器械的包装 成型、密封和装配工艺的验证要求
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
KS P ISO TR 80002-2:2021 医疗器械软件.第2部分:医疗器械质量体系软件的验证
Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO TR 80002-2-2021 医疗器械软件.第2部分:医疗器械质量体系软件的验证
Medical device software — Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证
Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证
Medical device software - Part 2: Validation of software for medical device quality systems
ISO TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证
Medical device software - Part 2: Validation of software for medical device quality systems
BB/T 0059-2012 医疗器械吸塑包装用共挤膜
Co-extruded film for medical device blister packaging
ISO/DIS 23417:1975 良好分销实践原则中非菌医疗器械包装的通用规范和验证方法
General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
21/30384564 DC BS ISO 23417 良好分销实践原则中非菌医疗器械包装的通用规范和验证方法
BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
KS T 5011-2020 包装.医疗器械运输包装的试验方法
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
DIN 96042:2006 医疗器械. 包装. 技术规范
Medical instruments - Packaging - Technical specification
T/SHBX 005-2023 《可灭菌医疗器械包装膜》
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
GB/T 19633-2005 最终灭菌医疗器械的包装
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
SN/T 3061-2011 进口医疗器械灭菌包装检验操作规程
Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices
BS EN ISO 11607-2:2020+A11:2022 最终灭菌医疗器械的包装 成型、密封和组装过程的验证要求
1 Scope This document specifies requirements for the development and validation of processes for packaging medical devices
Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN ISO 11607-2:2020+A1:2023 最终灭菌医疗器械的包装 成型、密封和装配工艺的验证要求
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
KS P ISO TR 80002-2:2021 医疗器械软件.第2部分:医疗器械质量体系软件的验证
Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO TR 80002-2-2021 医疗器械软件.第2部分:医疗器械质量体系软件的验证
Medical device software — Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证
Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证
Medical device software - Part 2: Validation of software for medical device quality systems
ISO TR 80002-2:2017 医疗器械软件第2部分:医疗器械质量体系软件的验证
Medical device software - Part 2: Validation of software for medical device quality systems
BB/T 0059-2012 医疗器械吸塑包装用共挤膜
Co-extruded film for medical device blister packaging
编辑：北检院编辑部
