《无菌医疗器械初包装选择指南》阅读记录目录一、内容描述................................................31.1背景介绍.............................................41.2目的和意义...........................................4二、无菌医疗器械概述........................................52.1无菌医疗器械定义.....................................62.2无菌医疗器械特点.....................................72.3无菌医疗器械分类.....................................8三、初包装材料选择.........................................103.1常用初包装材料种类..................................113.1.1一次性使用无菌包装..............................123.1.2可重复使用无菌包装..............................133.2初包装材料性能要求..................................143.2.1持久性..........................................153.2.2无菌性..........................................163.2.3安全性..........................................173.2.4方便性..........................................19四、初包装设计原则与要点...................................204.1设计原则............................................204.1.1符合法规要求....................................214.1.2保障产品安全性..................................224.1.3满足使用需求....................................234.2设计要点............................................244.2.1包装结构设计....................................254.2.2材料选择........................................264.2.3工艺设计........................................274.2.4检验与测试......................................28五、初包装选用指南.........................................305.1一次性使用无菌包装选用指南..........................315.1.1适用产品范围....................................325.1.2选用要点........................................325.2可重复使用无菌包装选用指南..........................335.2.1适用产品范围....................................345.2.2选用要点........................................34六、无菌医疗器械包装试验与验证.............................356.1试验目的与意义......................................356.2试验项目与方法......................................366.3试验结果分析与评价..................................37七、结论与建议.............................................387.1总结全文....................................