NF ISO 13004, S98-300 (12/2022)

This document describes a method for justifying a chosen sterilizing dose of 17.5 kGy, 20 kGy, 22.5 kGy, 27.5 kGy, 30 kGy, 32.5 kGy or 35 kGy which makes it possible to obtain a level of sterility assurance (NAS) less than or equal to 10-6 for sterilization by irradiation of health products. This document also specifies a method for auditing the sterilizing dose to demonstrate the continued effectiveness of the justified sterilizing dose. NOTE 1 The choice and justification of the sterilizing dose makes it possible to satisfy the requirements relating to the establishment of the sterilizing dose in the process definition of ISO 11137-1. This document does not allow the justification of sterilizing doses other than a chosen sterilizing dose of 17.5 kGy, 20 kGy, 22.5 kGy, 27.5 kGy, 30 kGy, 32.5 kGy or 35 kGy. The method cannot justify a chosen sterilizing dose if the average bioburden of the article as a whole exceeds the limit specified for the chosen sterilizing dose (see Table 3). NOTE 2 Methods for justifying the chosen sterilizing doses of 25 kGy and 15 kGy are not covered by this document. They are described in ISO 11137-2. If it has been decided to use this method of establishing the sterilizing dose, the method is intended to be applied in accordance with the requirements ("shall") and recommendations ("should") stipulated herein.
(Automatic translation from French)