推荐医疗器械辐照灭菌.pptVIP

灭菌的定义 没有微生物 实际上，无法证明绝对没有微生物的说法 将无菌定义为污染品的概率为百万分之一 (10-6) 这也就是无菌保证水平 Sterility Assurance Level (SAL) 微生物的杀灭遵循对数规则 常用的灭菌方法 湿热灭菌 干热灭菌 气体灭菌 (环氧乙烷-Ethylene oxide) 辐射灭菌 (伽马/Gamma 或电子流) 过滤 其它 – 紫外, 蒸汽和甲醛过氧化氢 辐射灭菌概述 辐射灭菌属“特殊过程” 11137-1:2006: Generic requirements of the quality management system for design and development, production, installation and servicing are given in ISO 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognize that, for certain processes used in manufact