Status : Withdrawn

This standard has been revised by ISO 13004:2022

Abstract

ISO/TS 13004:2013 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. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

General information

  • Status
     : Withdrawn
    Publication date
     : 2013-05
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 57
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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