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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
Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
This European Standard specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intended
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
Packaging for terminally sterilized medical devices.Part 2: Validation requirements for forming, sealing and assembly processes
Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
This European Standard specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices.Part 1: Requirements for materials, sterile barrier systems and packaging systems
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
Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
This European Standard specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intended
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
Packaging for terminally sterilized medical devices.Part 2: Validation requirements for forming, sealing and assembly processes
Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
This European Standard specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices.Part 1: Requirements for materials, sterile barrier systems and packaging systems
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