Historical

ONORM EN ISO 11137-2:2012

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

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.

CONTENT PROVIDER
Austrian Standards Institute [on]

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