ISO 11137-2:20 06规定了确定达到规定的无菌要求所需的最小剂量的方法，以及证实使用25 kGy或15 kGy作为灭菌剂量以达到10-6的无菌保证水平（SAL）的方法。它还规定了剂量审核方法，以证明灭菌剂量的持续有效性。 ISO 11137-2:20 06定义了剂量确定和剂量审核的产品系列。

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.