ISO 11137-2:20 13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106的无菌保证水平SAL的方法。ISO 11137-2:20 13还规定了用于证明灭菌剂量持续有效性的灭菌剂量审核方法。 ISO 11137-2:20 13定义了灭菌剂量确定和灭菌剂量审核的产品系列。

ISO 11137-2:2013 specifies methods for 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.