Historical
BS EN ISO 11137-2:2007
Sterilization of health care products. Radiation. Establishing the sterilization dose (British Standard)
ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
CONTENT PROVIDER
British Standards Institution [bsi]
British Standards Institution [bsi]