scope:

Inclusions

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.

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.

Exclusions

This method is for the substantiation of a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5, or 35 kGy only and is not used to substantiate other sterilization doses. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).

NOTE 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.

Application

If the decision is made to use this method of sterilization dose establishment, the method is to be followed according to the requirements (shall) and guidance (should) stipulated herein.