ISO 11137-2:2006

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose ISO 11137-2:2006

Publication date:   Apr 19, 2006

Scope

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.