标准摘要
[中文适用范围]： 本标准规定了用于最终灭菌医疗器械的材料和包装系统的要求，包括无菌屏障系统的规范。
英文名称Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management