卫生保健品灭菌.辐射.确定灭菌剂量

文章摘要:ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level （SAL） of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

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