Historical
ONORM EN ISO 11137-2:2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) (Austrian Standard)
ISO 11137-2:2013 specifies methods for 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 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
CONTENT PROVIDER
Austrian Standards Institute [on]
Austrian Standards Institute [on]