ISO 11607-2-2006 终端无菌医学设备的包装.第2部分:组成、密封和装配过程的确认要求
【英文标准名称】: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes 【原文标准名称】: 终端无菌医学设备的包装.第2部分:组成、密封和装配过程的确认要求 【标准号】: ISO 11607-2-2006 【标准状态】: 现行 【国别】: 国际 【发布日期】: 2006-04 【实施或试行日期】: 【发布单位】: 国际标准化组织(IX-ISO)【起草单位】: ISO/TC 198【标准类型】: ()【标准水平】: ()【中文主题词】: 定义;设计;可处置的;成形;作标记;材料规范;医疗产品;包装件;包装材料;性能;物理试验;公共卫生;合格;质量;质量保证;重新使用;抽样方法;密封;成型;规范;规范(验收);消毒阻挡系统;无菌;试验;证实;外观检查(试验)【英文主题词】: Definitions;Design;Disposables;Forming;Marking;Materials specification;Medical devices;Medical products;Packages;Packaging material;Performance;Physical testing;Public health;Qualifications;Quality;Quality assurance;Reuse;Sampling methods;Sealing;Shaping;Specification;Specification (approval);Sterile barrier systems;Sterility;Testing;Validation;Visual inspection (testing)【摘要】: This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.【中国标准分类号】: C30【国际标准分类号】: 11_080_30【页数】: 11P;A4【正文语种】: 英语
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