Standard

ISO 11137-2:2006

Withdrawn

Note: This standard has a new edition: ISO 11137-2:2013

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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.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 1
  • Version: 1
  • Document type: IS
  • ICS 11.080.01
  • ISO TC ISO/TC 198

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