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CEN/TC 102
Sterilizers for medical purposes

CENIntroOrganisationDirectivesStandardsTC 102TC 204CommentsReportsArticles

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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: Dipl.-Ing E. Dennhöfer Secretary: Dipl.-Biol A. Müller Working Groups: TC 102 / WG 2 Testing TC 102 / WG 3 Requirements TC 102 / WG 4 Packaging materials TC 102 / WG 5 Small sterilizers TC 102 / WG 6 Gas sterilizers TC 102 / WG 7 Biological and chemical indicators TC 102 / WG 8 Performance requirements and testing for washer-disinfectors

Structure Standards under development Published standards CEN/TC 102 - Standards under development (work started, drafts issued) Reference Title EN 285:2006/prA1 Sterilization - Steam sterilizers - Large sterilizers prEN ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO/FDIS 11138-1:2006) prEN ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO/FDIS 11138-2:2006) prEN ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO/FDIS 11138-3:2006) prEN ISO 11138-4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO/FDIS 11138-4:2006) prEN ISO 11138-5 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO/FDIS 11138-5:2006) prEN ISO 11140-3 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test (ISO/DIS 11140-3:2005) prEN ISO 11140-4 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration (ISO/DIS 11140-4:2005) prEN ISO 14161 rev Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results prEN ISO 15882 rev Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results prEN ISO 15883-4 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO/DIS 15883-4:2005)

Structure Standards under development Published standards CEN/TC 102 - Published standards Reference Title CEN ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005) EN 13060:2004 Small steam sterilizers EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing EN 1422:1997 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods EN 1422:1997/AC:2002 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements EN 866-2:1997 Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers EN 866-2:1997/AC:1998 Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizers EN 866-5:1999 Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers EN 866-6:1999 Biological systems for testing sterilizers and sterilization processes - Part 6: Particular systems for use in dry heat sterilizers EN 866-7:1999 Biological systems for testing sterilizers and sterilization processes - Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers EN 866-8:1999 Biological systems for testing sterilizers and sterilization processes - Part 8: Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers EN 867-3:1997 Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test EN 867-3:1997/AC:1998 Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test EN 867-4:2000 Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration EN 867-5:2001 Non-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 868-10:2000 Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods EN 868-2:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods EN 868-3:1999 Packaging materials and systems for medical devices which are to be sterilized - 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 868-4:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods EN 868-5:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods EN 868-5:1999/AC:2001 Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods EN 868-6:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods EN 868-7:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods EN 868-8:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods EN 868-9:2000 Packaging materials and systems for medical devices which are to be sterilized - Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods EN ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) EN ISO 14161:2000 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000) EN ISO 15882:2003 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2003) EN ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) EN ISO 15883-2:2006 Washer-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 15883-3:2006 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)

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