湿热灭菌程序的验证：灭菌程序的设计、开发、确认以及日常控制目录1.0 引言 .............................................................................................................................................4 1.1 范围 ......................................................................................................................................4 2.0 术语 .............................................................................................................................................5 3.0 灭菌科学 ...................................................................................................................................11 3.1 灭菌模式 ...........................................................................................................................12 3.1.1 耐热参数（ DT）.....................................................................................................13 3.1.2 温度系数（ z 值） ...................................................................................................15 3.1.3 灭菌率（ Lethal Rate ）和累计杀灭时间（lethality ，F） ....................................16 3.2 灭菌指示剂 ........................................................................................................................20 3.2.1 生物指示剂（ BIs）................................................................................................20 3.2.2 化学监测器 .............................................................................................................21 3.3 热力学和蒸汽质量............................................................................................................22 3.3.1 温度和热量 .............................................................................................................22 3.3.2 蒸汽 .........................................................................................................................28 3.3.3 纯蒸汽质量...
