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ISO/TC 198  - Sterilization of health care products

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Standards and projects under the direct responsibility of ISO/TC 198 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO 11135-1:2007
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
90.92 11.080.01ISO/TC 198
ISO/TS 11135-2:2008
Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1
90.92 11.080.01ISO/TC 198
ISO/TS 11135-2:2008/Cor 1:2009
60.60 11.080.01ISO/TC 198
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
90.92 11.080.01ISO/TC 198
ISO 11137-1:2006/Amd 1:2013
60.60 11.080.01ISO/TC 198
ISO 11137-2:2013
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
60.60 11.080.01ISO/TC 198
ISO 11137-3:2006
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
90.92 11.080.01ISO/TC 198
ISO 11138-1:2006
Sterilization of health care products -- Biological indicators -- Part 1: General requirements
90.93 11.080.01ISO/TC 198
ISO 11138-2:2006
Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
90.93 11.080.01ISO/TC 198
ISO 11138-3:2006
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
90.93 11.080.01ISO/TC 198
ISO 11138-4:2006
Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
90.93 11.080.01ISO/TC 198
ISO 11138-5:2006
Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
90.93 11.080.01ISO/TC 198
ISO/TS 11139:2006
Sterilization of health care products -- Vocabulary
90.92 11.080.01
01.040.11
ISO/TC 198
ISO 11140-1:2005
Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
90.92 11.080.01ISO/TC 198
ISO 11140-3:2007
Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
90.93 11.080.01ISO/TC 198
ISO 11140-3:2007/Cor 1:2007
60.60 11.080.01ISO/TC 198
ISO 11140-4:2007
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
90.93 11.080.01ISO/TC 198
ISO 11140-5:2007
Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
90.93 11.080.01ISO/TC 198
ISO 11607-1:2006
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
90.93 11.080.30ISO/TC 198
ISO 11607-2:2006
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
90.93 11.080.30ISO/TC 198
ISO 11737-1:2006
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
90.93 11.080.01
07.100.10
ISO/TC 198
ISO 11737-1:2006/Cor 1:2007
60.60 11.080.01
07.100.10
ISO/TC 198
ISO 11737-2:2009
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
60.60 11.080.01
07.100.10
ISO/TC 198
ISO/TS 13004:2013
Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD
60.60 11.080.01ISO/TC 198
ISO 13408-1:2008
Aseptic processing of health care products -- Part 1: General requirements
90.93 11.080.01ISO/TC 198
ISO 13408-1:2008/Amd 1:2013
60.60 11.080.01ISO/TC 198
ISO 13408-2:2003
Aseptic processing of health care products -- Part 2: Filtration
90.60 11.080.01ISO/TC 198
ISO 13408-3:2006
Aseptic processing of health care products -- Part 3: Lyophilization
90.93 11.080.01ISO/TC 198
ISO 13408-4:2005
Aseptic processing of health care products -- Part 4: Clean-in-place technologies
90.20 11.080.01ISO/TC 198
ISO 13408-5:2006
Aseptic processing of health care products -- Part 5: Sterilization in place
90.93 11.080.01ISO/TC 198
ISO 13408-6:2005
Aseptic processing of health care products -- Part 6: Isolator systems
90.93 11.080.01ISO/TC 198
ISO 13408-6:2005/Amd 1:2013
60.60 11.080.01ISO/TC 198
ISO 13408-7:2012
Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
60.60 11.080.01ISO/TC 198
ISO 14160:2011
Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
60.60 11.080.01ISO/TC 198
ISO 14161:2009
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
60.60 11.080.01ISO/TC 198
ISO 14937:2009
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
60.60 11.080.01ISO/TC 198
ISO 15882:2008
Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results
90.60 11.080.01ISO/TC 198
ISO 15883-1:2006
Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests
90.20 11.080.10ISO/TC 198
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.
90.93 11.080.10ISO/TC 198
ISO 15883-3:2006
Washer-disinfectors -- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
90.93 11.080.10ISO/TC 198
ISO 15883-4:2008
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
90.92 11.080.10ISO/TC 198
ISO/TS 15883-5:2005
Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy
90.60 11.080.10ISO/TC 198
ISO 15883-6:2011
Washer-disinfectors -- Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
60.60 11.080.10ISO/TC 198
ISO 17664:2004
Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
90.92 11.080.01ISO/TC 198
ISO 17665-1:2006
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
90.93 11.080.01ISO/TC 198
ISO/TS 17665-2:2009
Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1
60.60 11.080.01ISO/TC 198
ISO/TS 17665-3:2013
Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
60.60 11.080.01ISO/TC 198
ISO 18472:2006
Sterilization of health care products -- Biological and chemical indicators -- Test equipment
90.93 11.080.01ISO/TC 198
ISO 20857:2010
Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
60.60 11.080.01ISO/TC 198
ISO 25424:2009
Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
60.60 11.080.01ISO/TC 198