1 Scope
1.1 Inclusions
This Technical Specification describes a method for substantiating a selected sterilizationdose 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 sterilizationdose audit used to demonstrate the continued effectiveness of the substantiated sterilizationdose.
NOTE Selection and substantiation of the sterilizationdose is used to meet the requirements for establishing the sterilizationdose within process definition in ISO 11137-1.