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CEN/TC 102 Sterilizers for medical purposes - English Version

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CEN/TC 102
Sterilizers for medical purposes

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 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
Chairman:Dipl.-Ing E. Dennhöfer
F & M Lautenschläger
Secretariat:DIN
Secretary:Dr. V. Sattelmayer
DIN-Berlin
Subsector:S18
Creation:1982
Liaisons:CEPIC; EAPC; ESPA; EUCOMED; EUROM VI
Working Groups:
TC 102 / WG 1Terminology

To promote uniformity and clarity in understanding by adoption of standardized terminology - not active - awaiting recommendation from CEN/BT WG /2

Convenor: 
TC 102 / WG 2Testing

To prepare test methods for the verification of performance requirements on steam sterilizers

Convenor:Mr K. W. Oates
NHS Estates
TC 102 / WG 3Requirements

To prepare performance requirements for large steam sterilizers

Convenor:Dipl.-Ing. D. Achterberg
MMM Münchener Medizin Mechanik GmbH
TC 102 / WG 4Packaging materials

To prepare Standards for single use and reusable packaging materials for sterilization of wrapped goods which will maintain sterility of goods in transit and storage and will facilitate the aseptic presentation of goods at the point of use

Convenor:Mr T. Galekop
Ahlstrom FiberComposites
TC 102 / WG 5Small sterilizers

To prepare performance requirements and test methods for steam sterilizers for medical devices with a chamber volume less than 1 sterilization unit

Convenor: 
TC 102 / WG 6Gas sterilizers

To specify performance requirements and test methods for sterilizers using other than steam or air and giving recognition to operational safety requirements

Convenor:Dr B. Nystrom
 
TC 102 / WG 7Biological and chemical indicators

To prepare standards for the performance of indicators based on physical, chemical or biological systems

Convenor:Mr D. Hurrell
Healthcare Science Ltd
TC 102 / WG 8Performance requirements and testing for washer-disinfectors

To prepare performance requirements and test methods for washer-disinfectors that are intended to be used for washing and disinfection of re-usable articles contaminated by humans or animal products generated in medical, dental, pharmaceutical and veterinary establishments. The disinfection process options include thermal, chemical and combined thermal/chemical. Microbiological efficiency tests of chemical disinfectants intended for the disinfection of re-usable medical devices are the responsibility of CEN/TC 215. Safety requirements for washer-disinfectors are the responsibility of IEC/TC66/WG 7 and are given in EN61010 part 1 and in the current work item IEC 1010-2045.

Convenor:Dr R. Simpson
Healthcare Science Ltd

Structure Standards under development Published standards

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

ReferenceTitle
EN 285:2006/prA1Sterilization - Steam sterilizers - Large sterilizers
prEN ISO 11138-1Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO/FDIS 11138-1:2006)
prEN ISO 11138-2Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO/FDIS 11138-2:2006)
prEN ISO 11138-3Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO/FDIS 11138-3:2006)
prEN ISO 11138-4Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO/FDIS 11138-4:2006)
prEN ISO 11138-5Sterilization 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 11140-3Sterilization 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 11140-4Sterilization 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 revSterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
prEN ISO 15882 revSterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
prEN ISO 15883-4Washer-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

ReferenceTitle
CEN ISO/TS 15883-5:2005Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
EN 13060:2004Small steam sterilizers
EN 14180:2003Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 1422:1997Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 1422:1997/AC:2002Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 285:2006Sterilization - Steam sterilizers - Large sterilizers
EN 866-1:1997Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements
EN 866-2:1997Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers
EN 866-2:1997/AC:1998Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers
EN 866-3:1997Biological systems for testing sterilizers and sterilization processes - Part 3: Particular systems for use in moist heat sterilizers
EN 866-5:1999Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers
EN 866-6:1999Biological systems for testing sterilizers and sterilization processes - Part 6: Particular systems for use in dry heat sterilizers
EN 866-7:1999Biological systems for testing sterilizers and sterilization processes - Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizers
EN 866-8:1999Biological systems for testing sterilizers and sterilization processes - Part 8: Particular requirements for self-contained biological indicator systems for use in ethylene oxide sterilizers
EN 867-3:1997Non-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:1998Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test
EN 867-4:2000Non-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 867-5:2001Non-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 868-10:2000Packaging 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 868-2:1999Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:1999Packaging 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 868-4:1999Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods
EN 868-5:1999Packaging 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:2001Packaging 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 868-6:1999Packaging 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 868-7:1999Packaging 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 868-8:1999Packaging 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 868-9:2000Packaging 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 11140-1:2005Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
EN ISO 11607-1:2006Packaging 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 14161:2000Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000)
EN ISO 15882:2003Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2003)
EN ISO 15883-1:2006Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
EN ISO 15883-2:2006Washer-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 15883-3:2006Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
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
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© 2009 WFHSS • Updated: 24 September 2008, 15:17 [GMT]