LINKS

Association for the Advancement of Medical Instrumentation

International Organisation for Standardisation

BSI Group

RPSMUG – Radiation Process Simulation and Modelling User Group

 

STANDARDS

EN ISO 14937:2009  Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

EN 556-1:2006  Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Requirements for terminally sterilized medical devices    ANSI/AAMI ST67:2011  Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”

EN ISO 11137-1:2006  Sterilization of health care products — Radiation — Part 1:
Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11137-2:2012  Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
EN ISO 11137-3:2006  Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

EN ISO 11737-1:2006/Cor 1 2007:  Sterilization of medical devices – Microbiological  methods – Part 1: Determination of the population of microorganisms on products

EN ISO 11737-2:2009  Sterilization of medical devices – Microbiological methods –          Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 14470:2011 Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food

 

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