DIN CEN ISO/TS 13004 DIN SPEC 13223:2014-10

This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. The document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.