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ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
standard by International Organization for Standardization, 04/01/2006
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Full Description
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.