ISO 11137-2:2006

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

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  • Status :  Withdrawn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
  • Edition : 1
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.01
    Sterilization and disinfection in general

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

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