湿热灭菌工艺验证指南

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1、湿热灭菌工艺验证指南中国医药设备工程协会2008年12月1目录一、范围........................................................................................................................3二、目的........................................................................................................................3三、术语.

2、.......................................................................................................................3四、湿热灭菌基础........................................................................................................74.1湿热灭菌的机理...........................................

3、.......................................................74.2影响芽孢耐热性的因素......................................................................................74.3湿热灭菌中的能量转移......................................................................................84.4湿热灭菌中微生物杀灭的数学模式............

4、......................................................9五、灭菌法选择的基本原则......................................................................................11六、灭菌方法的开发及选定......................................................................................126.1湿热灭菌方法选择决策树.................

5、...............................................................126.2过度杀灭法........................................................................................................146.3残存概率法...................................................................................................

6、.....146.4装载类型的界定...............................................................................................156.5湿热灭菌对介质的要求....................................................................................166.5.1蒸汽..................................................................

7、............................................166.5.2压缩空气......................................................................................................176.5.3冷却水..........................................................................................................17七、湿热灭菌器的程