Status : Withdrawn

This standard has been revised by ISO 11137-2:2012

Abstract

ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

General information

  • Status
     : Withdrawn
    Publication date
     : 2006-04
    Corrected version (en)
     : 2006-07
    Corrected version (fr)
     : 2006-07
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 60
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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