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General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
Medical instruments - Packaging - Technical specification
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
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
Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices
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
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
Medical device software — Part 2: Validation of software for medical device quality systems
Medical device software — Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
Co-extruded film for medical device blister packaging
General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
Medical instruments - Packaging - Technical specification
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
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
Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices
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
Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
Medical device software — Part 2: Validation of software for medical device quality systems
Medical device software — Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
Co-extruded film for medical device blister packaging
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