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CEN/TC 204 Sterilization of medical devices - English Version

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CEN/TC 204
Sterilization of medical devices

CENIntroOrganisationDirectivesStandardsTC 102TC 204CommentsReportsArticles

We only maintain a list of the CEN Technical Committees and Working Groups with relevance to hospital sterile supply on the WFHSS Website. Please check out the CEN Website at http://www.cenorm.be for more information.


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
Chairman: Dr E. V. Hoxey
Secretariat: BSI
Secretary: Mrs C. Martin
BSI
Subsector: S18
Creation: 1989
Liaisons: AIII; EDOM; ESH; EUCOMED; EUROM VI; FIDE; IAPM
Working Groups:
TC 204 / WG 1 Ethylene oxide sterilization
Convenor: Dr H. W. Winckels
P/A Bakken Research Centre BV
TC 204 / WG 2 Sterilization by irradiation
Convenor: Mr P. Vidal
AIII
TC 204 / WG 3 Steam sterilization
Convenor: Mr K. W. Oates
NHS Estates
TC 204 / WG 4 Co-ordination
Convenor: Dr B. Nyströom
Huddinge University Hospital
TC 204 / WG 5 Bioburden of medical devices
Convenor: Dr E. V. Hoxey
Dept of Health
TC 204 / WG 6 Microbiological quality of processed medical devices
Convenor: Dr B. Nyströom
Huddinge University Hospital
TC 204 / WG 7 Liquid chemical treatment of medical devices
Convenor: Dr H. W. Winckels
P/A Bakken Research Centre BV
TC 204 / WG 8 Aseptic processing of medical devices
Convenor: Dr B. Matthews
 
TC 204 / WG 9 General requirements for sterilization
Convenor:  
TC 204 / WG 10 Information for re-processing of re-sterilizable devices
Convenor: Ms G. A. Sills
ESH

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)
WFHSS - World Forum for Hospital Sterile Supply :: CEN :: TC 204
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