Standardportfölj Kommittén för Sterilisering av medicintekniska produkter SIS/TK 349
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1 CEN ISO/TS :2008 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO (ISO/TS :2008) CEN ISO/TS :2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS :2005) CEN ISO/TS :2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO (ISO/TS :2009) EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) EN 12353:2006 EN 1275:2005 EN 1276:1997 EN 12791:2005 EN 13060:2004+A1:2009 EN 13610:2002 EN 13624:2003 EN 13697:2001 EN 13704:2002 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas - Test method and Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirement (phase 2/step 2) Small steam sterilizers Chemical disinfectants - Quantitative suspension test for the evaluation of virucidal activity against bacteriophages of chemical disinfectants used in food and industrial areas - Test method and Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2/step2) Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
2 EN 13727:2003 EN 13824:2004 EN 14180:2003+A2:2009 EN 14204:2004 EN 1422:1997+A1:2009 EN 14347:2005 EN 14348:2005 EN 14349:2007 EN 14476:2005+A1:2006 EN 14561:2006 EN 14562:2006 EN 14563:2008 EN 14675:2006 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
3 EN 14885:2006 EN 1499:1997 EN 1500:1997 EN 15424:2007 EN 1650:2008 EN 1656:2000 EN 1657:2005 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements (phase 2/step 2) Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2) Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary field - Test method and requirements (phase 2/step 1) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and EN 285:2006+A2:2009 Sterilization - Steam sterilizers - Large sterilizers 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 556-1:2001/AC:2006 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 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 :2009 EN 868-2:2009 EN 868-3:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods Packaging 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
4 EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods EN 868-5:2009 EN 868-6:2009 EN 868-7:2009 EN 868-8:2009 EN 868-9:2009 EN ISO :2007 EN ISO :2006 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN Requirements and test methods Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO :2007) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO :2006) EN ISO :2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO :2006, corrected version ) EN ISO :2007/AC:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO :2006/Cor 1:2009) EN ISO :2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO :2006) EN ISO :2006 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO :2006) EN ISO :2009 EN ISO :2009 EN ISO :2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO :2006) Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO :2006) Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO :2006) EN ISO :2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for lowtemperature steam and formaldehyde sterilization processes (ISO :2006) EN ISO :2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO :2005)
5 EN ISO :2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO :2007, including Cor 1:2007) EN ISO :2007 Sterilization 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 :2007) EN ISO :2009 EN ISO :2006 EN ISO :2006 EN ISO :2006/AC:2009 EN ISO :2000 EN ISO 14160:1998 EN ISO 14161:2009 EN ISO 14937:2000 EN ISO 14937:2000/AC:2005 EN ISO 15882:2008 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO :2006) Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO :2006) Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO :2006) Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO :2006/Cor 1:2007) Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO :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) Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) 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) 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) Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008) EN ISO :2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO :2006) EN ISO :2009 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 :2006)
6 EN ISO :2009 EN ISO :2009 EN ISO 17664:2004 EN ISO :2006 EN ISO 18472:2006 ISO/TS :2008/Cor 1:2009 ISO/TS 11139:2006 ISO :2007 ISO :2008 ISO :2003 ISO :2006 ISO :2005 ISO :2006 ISO :2005 ISO/TS :2005 ISO 25424:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO :2006) Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO :2008) Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) 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 :2006) Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006) Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO Sterilization of health care products -- Vocabulary Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests Aseptic processing of health care products -- Part 1: General requirements Aseptic processing of health care products -- Part 2: Filtration Aseptic processing of health care products -- Part 3: Lyophilization Aseptic processing of health care products -- Part 4: Clean-in-place technologies Aseptic processing of health care products -- Part 5: Sterilization in place Aseptic processing of health care products -- Part 6: Isolator systems Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
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