发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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YY/T 0698的本部分提供了预期在使用前保持最终灭菌医疗器械菌的预成形屏障系统和包装系统的材料的要求和试验方法。 本部分未对ISO 11607-1的通用要求增加要求,这样,4.2中的专用要求可用以证实符合ISO 11607-1的一项或多项要求,但不是其全部要求
Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
1 Esta Norma Europeia especifica os requisitos e os métodos de ensaio para os materiais e sistemas de embalagem: - utilizados para embalar os
Packaging materials and systems for medical devices which are to be sterilized Part 1:General requirements and test methods
本文件规定了预期在使用前保持最终灭菌医疗器械菌的预成形屏障系统和包装系统的材料的要求和试验方法。本文件适用于预期为一次性使用的平纸包裹材料、皱纹纸包裹材料、非织造布包裹材料和预期为重复性使用的纺织包裹材料的性能测定
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
Packaging materials for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods.
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Packaging materials for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods.
Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers
GB/T19633 的本部分规定了材料、预成形菌屏障系统、菌屏麻系统和预期在使用前保持最终灭菌医疗器械菌的包装系统的要求和试验方法。 本部分适用于工业、医疗机构以及任何将医疗器械装和菌屏障系统后灭菌的情况。 本部分未包括菌制造医疗器械的菌屏障系统和包装系统的全部要求。 对药物与器械组合的
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.
YY/T 0698的本部分提供了预期在使用前保持最终灭菌医疗器械菌的预成形屏障系统和包装系统的材料的要求和试验方法。 本部分未对ISO 11607-1的通用要求增加要求,这样,4.2中的专用要求可用以证实符合ISO 11607-1的一项或多项要求,但不是其全部要求
Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
1 Esta Norma Europeia especifica os requisitos e os métodos de ensaio para os materiais e sistemas de embalagem: - utilizados para embalar os
Packaging materials and systems for medical devices which are to be sterilized Part 1:General requirements and test methods
本文件规定了预期在使用前保持最终灭菌医疗器械菌的预成形屏障系统和包装系统的材料的要求和试验方法。本文件适用于预期为一次性使用的平纸包裹材料、皱纹纸包裹材料、非织造布包裹材料和预期为重复性使用的纺织包裹材料的性能测定
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
Packaging materials for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods.
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Packaging materials for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods.
Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers
GB/T19633 的本部分规定了材料、预成形菌屏障系统、菌屏麻系统和预期在使用前保持最终灭菌医疗器械菌的包装系统的要求和试验方法。 本部分适用于工业、医疗机构以及任何将医疗器械装和菌屏障系统后灭菌的情况。 本部分未包括菌制造医疗器械的菌屏障系统和包装系统的全部要求。 对药物与器械组合的
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.