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ISO 11137-2:2012

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

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Publication date: 2012-03-15
Price: 204 vnd

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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.
Document identifier
ISO 11137-2:2012
Title
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO Category
TC 198: Sterilization of health care products
Publication date
2012-03-15
Status
Ineffective
International Relationship
BS EN ISO 11137-2:2012 * AAMI/ISO 11137-2:2012 * DIN EN ISO 11137-2
Cross references
Latest version
ISO 11137-2:2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Document identifier ISO 11137-2:2013
Publication date 2013-06-01
Classification 11.080.01. Sterilization and disinfection in general
Status Effective
*
History of version
ISO 11137-2:2013*ISO 11137-2:2012 * ISO 11137-2:2013 * ISO 11137-2:2012 * ISO 11137-2/Cor1:2009 * ISO 11137-2:2006 * ISO 11137:1995
Keywords
Classification
11.080.01. Sterilization and disinfection in general
Pages
Price 204 vnd

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