Historical
DIN EN ISO 11137-2:2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013 (Foreign Standard)
This part of ISO 11137 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. This part of IS 11137 also specifies methods of dose auditing to demonstrate the continued effectiveness of the sterilization dose.
CONTENT PROVIDER
Deutsches Institut für Normung [din]
Deutsches Institut für Normung [din]