Publications

The revision of EN ISO 11137-2 “Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose” published in 2012 contains a number of changes to the required dose tolerances and the actions to be taken if the tolerances are not met. This guidance note outlines the changes with respect to the 2007 version of the standard and reproduces the relevant clauses from the 2012 standard.