Publications

An updated version of document EN/ISO 11737-2 “Sterilization of health care products – Microbiological methods – Part 2: Tests of Sterility performed in the definition, validation and maintenance of a sterilisation process’” was published in 2019, replacing the version that had been published in 2009. Although the Scope and overall outline of the two documents are similar, there have been some changes in terms of terminology, more detailed guidance in appendices and a new Annex B. The purpose of this document is to highlight, in general terms, areas of difference between the two versions of the standard.