ISO 11607-1-2006 终端无菌医学设备的包装.第1部分:材料、消毒阻挡系统和包装系统的要求

标准号：ISO 11607-1-2006
中文标准名称：终端无菌医学设备的包装.第1部分:材料、消毒阻挡系统和包装系统的要求
英文标准名称：Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
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 barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary fordrug/device combinations.This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.