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WFHSS - World Forum for Hospital Sterile Supply

WFHSS - World Forum for Hospital Sterile Supply

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WFHSS - World Forum for Hospital Sterile Supply / CEN / TC 102

CEN/TC 102
Sterilizers for medical purposes

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 www.cen.eu for more information.


Structure Standards under development Published standards

CEN/TC 102 - Structure

CEN TC 102

Sterilizers for medical purposes

Standardization for sterilizers used in the medical field (preference being given to hospital use), for the accessories, and for the operation and maintenance of sterilizers. The objective is to ensure satisfactory sterilization and sterile products.
Web:CEN/TC 102 Work Programme
Secretariat:DIN
Chairperson:Mr. K. Hahnen
Secretary:Dipl.-Biol A. Müller
Working Groups:
TC 102 / WG 1Terminology
TC 102 / WG 2Testing
TC 102 / WG 3Requirements
TC 102 / WG 4Packaging materials
TC 102 / WG 5Small sterilizers
TC 102 / WG 6Gas sterilizers
TC 102 / WG 7Biological and chemical indicators
TC 102 / WG 8Performance requirements and testing for washer-disinfectors

Structure Standards under development Published standards

CEN/TC 102 - Standards under development (work started, drafts issued)

ReferenceTitle
prEN ISO 11140-6Sterilization of health care products - Chemical indicators - Part 6: Class 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO/AWI 11140-6:2007)
FprEN 1422 revSterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
prEN 16442Controlled environment storage cabinet for disinfected thermolabile endoscopes
FprCEN ISO/TS 16775Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/DTS 16775:2013)
prEN ISO 11138-6Sterilization of health care products - Biological Indicators - Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes (ISO/NP 11138-6:2008)
prEN 285Sterilization - Steam sterilizers - Large sterilizers
prEN 13060 revSmall steam sterilizers
FprEN 14180Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
prEN ISO 15883-7Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
prEN ISO 11140-1 revSterilization of health care products - Chemical indicators - Part 1: General requirements (ISO/DIS 11140-1:2012)
EN ISO 11607-1:2009/prA1Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2006/DAM 1:2013)
EN ISO 11607-2:2006/prA1Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2006/DAM 1:2013)
EN ISO 15883-1:2009/prA1Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/DAM 1: 2012)
prEN ISO 15883-4 revWasher-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

Structure Standards under development Published standards

CEN/TC 102 - Published standards

ReferenceTitle
CEN ISO/TS 15883-5:2005Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
EN 13060:2004+A2:2010Small steam sterilizers
EN 14180:2003+A2:2009Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 1422:1997+A1:2009Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 285:2006+A2:2009Sterilization - Steam sterilizers - Large sterilizers
EN 867-5:2001Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 868-10:2009Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
EN 868-2:2009Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2009Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN 868-4:2009Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN 868-5:2009Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-6:2009Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 868-7:2009Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 868-8:2009Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
EN 868-9:2009Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN ISO 11138-1:2006Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
EN ISO 11138-2:2009Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
EN ISO 11138-3:2009Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
EN ISO 11138-4:2006Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006)
EN ISO 11138-5:2006Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)
EN ISO 11140-1:2009Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
EN ISO 11140-3:2009Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
EN ISO 11140-4:2007Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
EN ISO 11607-1:2009Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
EN ISO 11607-2:2006Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
EN ISO 14161:2009Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
EN ISO 15882:2008Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
EN ISO 15883-1:2009Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
EN ISO 15883-2:2009Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
EN ISO 15883-3:2009Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
EN ISO 15883-4:2009Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
EN ISO 15883-6:2011Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
EN ISO 18472:2006Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
WFHSS - World Forum for Hospital Sterile Supply / CEN / TC 102