Historical
BS EN ISO 11137-2:2012
Sterilization of health care Products. Radiation. Establishing the sterilization dose (British 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
British Standards Institution [bsi]
British Standards Institution [bsi]