湿热灭菌的验证方案.doc

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1、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.............................................................................................................................................41.1范围....................................................................

2、..................................................................42.0术语.............................................................................................................................................53.0灭菌科学..............................

3、.....................................................................................................113.1灭菌模式...........................................................................................................................123.1.1耐热参数（DT）...

4、..................................................................................................133.1.2温度系数（z值）...................................................................................................153.1.3灭菌率（LethalRate）和累计杀灭时间（lethality

5、，F）....................................163.2灭菌指示剂........................................................................................................................203.2.1生物指示剂（BIs）.................................................................

6、...............................203.2.2化学监测器.............................................................................................................213.3热力学和蒸汽质量......................................................................................

7、......................223.3.1温度和热量.............................................................................................................223.3.2蒸汽...................................................................................................

8、......................283.3.3纯蒸汽质量的测试.................................................................................................284.0灭菌程序的开发.................................................................................................