The ISO 11137 standard is of particular importance due to the irradiation standard ISO 11137 requirements in the latest version being effectively mandatory in Europe since April 2009. Sterilization by irradiation is based on ISO 11137-1:2006 Sterilization of Health Care Products (Radiation - Part 1) focused on the requirements for development, validation and routine control of a sterilization process for medical devices. It is also based on ISO 11137-2:2006 Sterilization of Health Care Products (Radiation - Part 2) focused on establishing the sterilization dose.
American National Standard ANSI/AAMI/ISO 11137-2:2013 (Revision of ANSI/AAMI/ISO 11137-2:2012) Sterilization of health care products — Radiation —. ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control. Der Knochenmann Torrent.