Standard

ISO 11137-2:2012

Mar 2012 Withdrawn

Note: Latest version: ISO 11137-2:2013

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Abstract

ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

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Standard from ISO
Published: March 15 2012
Withdrawn: May 21 2013
Period for objection until: August 12 2010
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Revised by: ISO 11137-2:2013
Adopted by: SN EN ISO 11137-2:2012
Adopted by: NF EN ISO 11137-2:2012
Revises: ISO 11137-2:2006

ISO 11137-2:2012

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ISO 11137-2:2013

ISO 11137-2:2012

ISO 11137-2:2006

Abstract

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Version history History (3)

ISO 11137-2:2013

ISO 11137-2:2012

ISO 11137-2:2006

Abstract

Products specifications

Product Relations

Product life cycle