DIN CEN ISO/TS 13004:2014-10

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. 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. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. Furthermore, specfications for definition and maintenance of product families as well as criteria for selection and testing of products are specified. With selected worked examples for certain sterilization doses, the user receives information for substantiation of a selected sterilization dose and for sterilization dose audit. The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this Technical Specification; they are described in ISO 11137-2. This Technical Specification has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA), in collaboration with CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom). At DIN, the German Institute of Standardization e. V., the responsible Working Committee is NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at the Medical Standards Committee (NAMed).