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Standard and/or project under the direct responsibility of ISO/TC 198 Secretariat Stage ICS
ISO 11134:1994
Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
95.99
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
95.99
ISO 11135:1994
Medical devices — Validation and routine control of ethylene oxide sterilization
95.99
ISO 11135:1994/Cor 1:1994
Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrigendum 1
95.99
ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
90.20
ISO 11135:2014/Amd 1:2018
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release
60.60
ISO/TS 11135-2:2008
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
95.99
ISO/TS 11135-2:2008/Cor 1:2009
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 — Technical Corrigendum 1
95.99
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
90.93
ISO 11137-1:2006/Amd 1:2013
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
60.60
ISO 11137-1:2006/Amd 2:2018
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2
60.60
ISO 11137-2:2006
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
95.99
ISO 11137-2:2006/Cor 1:2009
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Technical Corrigendum 1
95.99
ISO 11137-2:2012
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
95.99
ISO 11137-2:2013
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
90.93
ISO 11137-3:2006
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
95.99
ISO 11137-3:2017
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
60.60
ISO 11137:1995
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
95.99
ISO 11137:1995/Amd 1:2001
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose setting
95.99
ISO 11137:1995/Cor 1:1997
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Technical Corrigendum 1
95.99
ISO/DTS 11137-4
Sterilization of health care products — Radiation — Part 4: Guidance on process control
30.20
ISO 11138-1:1994
Sterilization of health care products — Biological indicators — Part 1: General
95.99
ISO 11138-1:2006
Sterilization of health care products — Biological indicators — Part 1: General requirements
95.99
ISO 11138-1:2017
Sterilization of health care products — Biological indicators — Part 1: General requirements
60.60
ISO 11138-2:1994
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization
95.99
ISO 11138-2:2006
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
95.99
ISO 11138-2:2017
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
60.60
ISO 11138-3:1995
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization
95.99
ISO 11138-3:2006
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
95.99
ISO 11138-3:2017
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
60.60
ISO 11138-4:2006
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
95.99
ISO 11138-4:2017
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
60.60
ISO 11138-5:2006
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
95.99
ISO 11138-5:2017
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
60.60
ISO 11138-5:2017/NP Amd 1
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes — Amendment 1: Annex C: Alternative method for determining the D-value of LTSF SCBI
10.99
ISO 11138-7:2019
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
60.60
ISO/AWI 11138-6
Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes
20.00
ISO/AWI 11138-8
Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator
20.00
ISO 11139:2018
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
60.60
ISO/TS 11139:2001
Sterilization of health care products — Vocabulary
95.99
ISO/TS 11139:2006
Sterilization of health care products — Vocabulary
95.99
ISO 11140-1:1995
Sterilization of health care products — Chemical indicators — Part 1: General requirements
95.99
ISO 11140-1:1995/Amd 1:1998
Sterilization of health care products — Chemical indicators — Part 1: General requirements — Amendment 1
95.99
ISO 11140-1:2005
Sterilization of health care products — Chemical indicators — Part 1: General requirements
95.99
ISO 11140-1:2014
Sterilization of health care products — Chemical indicators — Part 1: General requirements
60.60
ISO 11140-2:1998
Sterilization of health care products — Chemical indicators — Part 2: Test equipment and methods
95.99
ISO 11140-3:2000
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicators for steam penetration test sheets
95.99
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
ISO 11140-3:2007/Cor 1:2007
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test — Technical Corrigendum 1
60.60
ISO 11140-4:2001
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators for steam penetration test packs
95.99
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
ISO 11140-5:2000
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for air removal test sheets and packs
95.99
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
ISO/CD 11140-6
Sterilization of health care products — Chemical indicators — Part 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizers
30.92
ISO 11607-1:2006
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
95.99
ISO 11607-1:2006/Amd 1:2014
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
95.99
ISO 11607-1:2019
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
60.60
ISO 11607-2:2006
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
95.99
ISO 11607-2:2006/Amd 1:2014
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
95.99
ISO 11607-2:2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
60.60
ISO 11607:1997
Packaging for terminally sterilized medical devices
95.99
ISO 11607:2003
Packaging for terminally sterilized medical devices
95.99
ISO 11737-1:1995
Sterilization of medical devices — Microbiological methods — Part 1: Estimation of population of microorganisms on products
95.99
ISO 11737-1:2006
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
95.99
ISO 11737-1:2006/Cor 1:2007
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Technical Corrigendum 1
95.99
ISO 11737-1:2018
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
60.60
ISO 11737-1:2018/DAmd 1
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
40.60
ISO 11737-2:1998
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
95.99
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
90.92
ISO 11737-3:2004
Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data
95.99
ISO/AWI 11737-3
Sterilization of medical devices — Microbiological methods — Part 3: Bacterial endotoxin testing
20.00
ISO/FDIS 11737-2
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
50.60
ISO/TS 13004:2013
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
90.93
ISO 13408-1:1998
Aseptic processing of health care products — Part 1: General requirements
95.99
ISO 13408-1:2008
Aseptic processing of health care products — Part 1: General requirements
90.92
ISO 13408-1:2008/Amd 1:2013
Aseptic processing of health care products — Part 1: General requirements — Amendment 1
60.60
ISO 13408-2:2003
Aseptic processing of health care products — Part 2: Filtration
95.99
ISO 13408-2:2018
Aseptic processing of health care products — Part 2: Sterilizing filtration
60.60
ISO 13408-3:2006
Aseptic processing of health care products — Part 3: Lyophilization
90.93
ISO 13408-4:2005
Aseptic processing of health care products — Part 4: Clean-in-place technologies
90.60
ISO 13408-5:2006
Aseptic processing of health care products — Part 5: Sterilization in place
90.93
ISO 13408-6:2005
Aseptic processing of health care products — Part 6: Isolator systems
90.92
ISO 13408-6:2005/Amd 1:2013
Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1
60.60
ISO 13408-7:2012
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
90.93
ISO/DIS 13408-6
Aseptic processing of health care products — Part 6: Isolator systems
40.60
ISO/NP 13408-1
Aseptic processing of health care products — Part 1: General requirements
10.99
ISO/TR 13409:1996
Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
95.99
ISO/TS 13409:2002
Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
95.99
ISO 13683:1997
Sterilization of health care products — Requirements for validation and routine control of moist heat sterilization in health care facilities
95.99
ISO 14160:1998
Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants
95.99
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
90.92
ISO/PRF 14160
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
50.60
ISO 14161:2000
Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
95.99
ISO 14161:2009
Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
95.99
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
95.99
ISO 14937:2000/Cor 1:2003
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 — Technical Corrigendum 1
95.99
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
90.93
ISO/TS 15843:2000
Sterilization of health care products — Radiation sterilization — Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
95.99
ISO/TR 15844:1998
Sterilization of health care products — Radiation sterilization — Selection of sterilization dose for a single production batch
95.99
ISO 15882:2003
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
95.99
ISO 15882:2008
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
90.93
ISO 15883-1:2006
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
90.92
ISO 15883-1:2006/Amd 1:2014
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests — Amendment 1
60.60
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
ISO 15883-3:2006
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
90.93
ISO 15883-4:2008
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
95.99
ISO 15883-4:2018
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
60.60
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
90.93
ISO 15883-7:2016
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
60.60
ISO/CD 15883-1
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
30.60
ISO/DIS 15883-5
Washer disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
40.20
ISO/TS 15883-5:2005
Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy
90.92
ISO/NP TS 16775
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
10.99
ISO/TS 16775:2014
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
90.92
ISO 17664:2004
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
95.99
ISO 17664:2017
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
60.60
ISO/DIS 17664-2
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
40.60
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
90.92
ISO/CD 17665
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
30.60
ISO/TS 17665-2:2009
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
90.92
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
90.92
ISO 18362:2016
Manufacture of cell-based health care products — Control of microbial risks during processing
60.60
ISO 18472:2006
Sterilization of health care products — Biological and chemical indicators — Test equipment
95.99
ISO 18472:2018
Sterilization of health care products — Biological and chemical indicators — Test equipment
60.60
ISO/DTS 19572
Sterilization of health care products — Guidance on the application of ISO14937 to the sterilization of medical devices using Ethylene Oxide in a flexible sterilization chamber
30.98
ISO/TS 19930:2017
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
60.60
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
90.93
ISO/DTS 21387
Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
30.60
ISO/CD TS 22421
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
30.60
ISO/NP 22441
Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
10.99
ISO/DTS 22456
Sterilization of healthcare products — Microbiological Methods— Guidance on conducting bioburden determinations and tests of sterility for tissue-based products
30.60
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
95.99
ISO 25424:2018
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
60.60

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