Reference | Title |
CEN ISO/TS 11135-2:2008 | Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008) |
CEN ISO/TS 11135-2:2008/AC:2009 | Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008/Cor 1:2009) |
CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
EN 556-1:2001 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
EN 556-1:2001/AC:2006 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
EN 556-2:2003 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
EN ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
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 (ISO 11137-1:2006) |
EN ISO 11137-1:2006/A1:2013 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013) |
EN ISO 11137-2:2013 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
EN ISO 11137-3:2006 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) |
EN ISO 11737-1:2006 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
EN ISO 11737-1:2006/AC:2009 | Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006/Cor 1:2007) |
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 11737-2:2009) |
EN ISO 13408-1:2011 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008) |
EN ISO 13408-1:2011/A1:2013 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013) |
EN ISO 13408-2:2011 | Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
EN ISO 13408-3:2011 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
EN ISO 13408-4:2011 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
EN ISO 13408-5:2011 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
EN ISO 13408-6:2011 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
EN ISO 13408-6:2011/A1:2013 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005/Amd 1:2013) |
EN ISO 14160:2011 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
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 (ISO 14937:2009) |
EN ISO 17664:2004 | Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) |
EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |