ISO 11607-2:2006规定了对终端消毒的医疗器械进行包装的过程的开发和验证要求。这些过程包括预成型无菌屏障系统，无菌屏障系统和包装系统的成型，密封和组装。 ISO 11607-2:2006适用于工业，医疗保健设施以及医疗器械包装和消毒的地方。 ISO 11607-2:2006并不涵盖无菌生产包装医疗器械的所有要求。药物/器械组合也可能需要额外的要求

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.