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.
Revises
ISO 11137:1995
Revises
ISO 11137:1995/Cor 1:1997
Revises
ISO 11137:1995/Amd 1:2001
WITHDRAWN
ISO 11137-2:2006
95.99
Withdrawal of Standard
Mar 15, 2012
Amended by
ISO 11137-2:2006/PWI Amd 1
Corrected by
ISO 11137-2:2006/Cor 1:2009
WITHDRAWN
ISO 11137-2:2012
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