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CEN/TC 204
Sterilization of medical devices

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Structure Standards under development Published standards CEN/TC 204 - Structure CEN TC 204 Sterilization of medical devices Standardization in the field of validation and monitoring of sterilization processes as used in manufacturing of medical devices. Web: CEN/TC 204 Work Programme Secretariat: BSI Chairperson: Dr E. V. Hoxey Secretary: Mr D. Upstone Working Groups: TC 204 / WG 1 Ethylene oxide sterilization TC 204 / WG 2 Sterilization by irradiation TC 204 / WG 3 Steam sterilization TC 204 / WG 4 Co-ordination TC 204 / WG 5 Bioburden of medical devices TC 204 / WG 6 Microbiological quality of processed medical devices TC 204 / WG 7 Liquid chemical treatment of medical devices TC 204 / WG 8 Aseptic processing of medical devices TC 204 / WG 9 General requirements for sterilization

Structure Standards under development Published standards CEN/TC 204 - Standards under development (work started, drafts issued) Reference Title prEN ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135-1:2005) prEN ISO 17665-1 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/FDIS 17665:2006) prEN 15424 Sterilization of medical devices - Development, validation and routine control of sterilization processes - Low Temperature Steam and Formaldehyde prCEN ISO/TS 11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 prCEN ISO/TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 EN ISO 11737-1:2006/prAC Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

Structure Standards under development Published standards CEN/TC 204 - Published standards Reference Title EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements EN 550:1994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization EN 554:1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat 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 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices 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 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006) 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 11737-2:2000 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998) EN ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998) EN ISO 14937:2000 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 14937:2000) EN ISO 14937:2000/AC:2003 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 14937:2000) EN ISO 14937:2000/AC:2005 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 14937:2000) 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)

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