ANSI/AAMI/ISO 11607-2-2006 最后灭菌的医疗器械的包装.第2部分:组成,密封和装配过程的确认和要求

标准号：ANSI/AAMI/ISO 11607-2-2006
中文标准名称：*后灭菌的医疗器械的包装.第2部分:组成,密封和装配过程的确认和要求
英文标准名称：Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes
标准类型：C08
发布日期：2005/12/23 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C08
国际标准分类号：11.080.30
引用标准：ISO 11607-1
适用范围：Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.