SR EN ISO 11137-2:2012

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

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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General information

Status : Withdrawn
Approval date : 8/31/2012
Withdrawal date : 11/29/2013
Number of pages : 85
ICS : 13.140 Noise with respect to human beings
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 11137-2:2007/AC:2009
Replaces SR EN ISO 11137-2:2007
Replaced by SR EN ISO 11137-2:2013