DIN EN ISO 11137-2:2012-07

Methods for the determination of the sterilization dose and methods used for audits of continued effectiveness of the determined sterilization dose are specified. This includes criteria for definition of product families and selection as well as product review used for determination of the sterilization dose. Methods for determining the sterilization dose comprise - methods for the determination of a product-specific sterilization dose - methods serving for verification that a sterility assurance level (SAL) of at least 10 ^-6 is achieved with a predetermined sterilization dose of 25 kGy or 15 kGy. The standard contains detailed examples for each individual method. The International Standard has been prepared by 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). On the national level, Working Committee NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at NAMed is responsible.