ISO 13004:2022

This document describes a method for substantiating a selected sterilization dose of 17,5kGy, 20kGy, 22,5kGy, 27,5kGy, 30kGy, 32,5kGy or 35kGy 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 sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO11137‑1.

This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5kGy, 20kGy, 22,5kGy, 27,5kGy, 30kGy, 32,5kGy or 35kGy. 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 Table3).

NOTE 2 The methods for substantiation of selected sterilization doses of 25kGy and 15kGy are not included in this document. They are described in ISO11137‑2.

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