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SSH ISO 13004:2022

Sterilization of health care products – Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

Sep 29, 2023

General information

60.60     Sep 29, 2023

DPS

DPS/KT 205

International Standard

11.080.01  

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Scope

This document describes a method for substantiating a selected sterilization dose 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 sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

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PUBLISHED
SSH ISO 13004:2022
60.60 Standard published
Sep 29, 2023