BS EN ISO 11607-2-2006 终端无菌医学设备的包装.组成、密封和装配过程的确认要求

标准号：BS EN ISO 11607-2-2006
中文标准名称：终端无菌医学设备的包装.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 - Validation requirements for forming, sealing and assembly processes
标准类型：C47
发布日期：2006/5/31 12:00:00
实施日期：2006/5/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.30
适用范围：ISO 11607-2:2006 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.ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.