BS EN ISO 11607-1-2009 终端无菌医学设备的包装.材料、无菌屏障系统和包装系统的要求

标准号：BS EN ISO 11607-1-2009
中文标准名称：终端无菌医学设备的包装.材料、无菌屏障系统和包装系统的要求
英文标准名称：Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
标准类型：C47
发布日期：2010/2/28 12:00:00
实施日期：2010/2/28 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.30
引用标准：ISO 5636-5-2003
适用范围：This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barriersystems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminallysterilized medical devices until the point of use.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices areplaced in sterile barrier systems and sterilized.This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems formedical devices that are manufactured aseptically. Additional requirements might also be necessary fordrug/device combinations.