1 Scope
This document describes a method for substantiating a selected sterilizationdose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves
a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This document also specifies a method of sterilizationdose audit used to demonstrate the continued effectiveness of the substantiated sterilizationdose.
NOTE 1 Selection and substantiation of the sterilizationdose is used to meet the requirements for establishing the sterilizationdose within process definition in ISO 11137‑1.
This document does not apply to other sterilizationdoses than the substantiation of a selected sterilizationdose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is
not used for the substantiation of a selected sterilizationdose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilizationdose (see Table 3).
NOTE 2 The methods for substantiation of selected sterilizationdoses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137‑2.
If the decision is made to use this method of sterilizationdose establishment, the method is intended to be followed in accordance with the requirements
(shall) and guidance (should) stipulated herein.