Sterilization of health care products. Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices Ingestion-build-183098 Alignment with ISO/IEC 20000-2:2005 Information

Alignment with ISO/IEC 20000-2:2005 Information technology — Service management — Part 2: Code of practice

An informative annex contains a non-exhaustive list of test organisms for which this standard can be applied

BS EN ISO 15747:2019 has made some technical changes compared to ISO 15747:2010

21 Loss of mass 6

Sterilization of health care products. Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices Ingestion-build-183098 Alignment with ISO/IEC 20000-2:2005 InformationBS EN ISO 11135 1: 2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological