Publications

An updated version of document EN ISO 11137-3 “Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development, validation and routine control” was published in 2017, replacing the original version that had been published in 2006. Although the Scope and overall outline of the two documents are similar, there have been significant changes in terms of the amount of guidance provided, particularly with respect to measurement uncertainty and the use of dosimetry in the OQ, PQ and routine control aspects of the radiation sterilization process. The purpose of this document is to highlight, in general terms, areas of difference between the two versions of the standard. It is not intended as a substitute for reading the standard itself and does not attempt to provide any additional guidance.