Standards catalogue

ISO/TC 198

Sterilization of health care products

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Standard and/or project under the direct responsibility of ISO/TC 198 Secretariat Stage ICS
ISO 11134:1994 [Withdrawn]
Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization
95.99
ISO 11135:1994 [Withdrawn]
Medical devices -- Validation and routine control of ethylene oxide sterilization
95.99
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
60.60
ISO 11135:2014/DAmd 1 [Under development]
Revision of Annex E, Single batch release
40.60
ISO 11135-1:2007 [Withdrawn]
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ISO/TS 11135-2:2008 [Withdrawn]
Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1
95.99
95.99
ISO 11137:1995 [Withdrawn]
Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization
95.99
ISO 11137:1995/Amd 1:2001 [Withdrawn]
Selection of items for dose setting
95.99
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
60.60
ISO 11137-1:2006/DAmd 2 [Under development]
.
40.20
ISO 11137-2:2006 [Withdrawn]
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
95.99
95.99
ISO 11137-2:2012 [Withdrawn]
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
60.60
ISO 11137-3:2006 [Withdrawn]
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/NP TS 11137-4 [Under development]
Sterilization of health care products -- Radiation -- Part 4: Guidance on process control
10.99
ISO 11138-1:1994 [Withdrawn]
Sterilization of health care products -- Biological indicators -- Part 1: General
95.99
ISO 11138-1:2006 [Withdrawn]
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 [Withdrawn]
Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization
95.99
ISO 11138-2:2006 [Withdrawn]
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 [Withdrawn]
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization
95.99
ISO 11138-3:2006 [Withdrawn]
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 [Withdrawn]
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 [Withdrawn]
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 [Under development]
Annex C: Alternative method for determining the D-value of LTSF SCBI
10.99
ISO/NP 11138-6 [Under development]
Sterilization of health care products -- Biological indicators -- Part 6: Biological indicators for hydrogen peroxide sterilization processes
10.99
ISO/DIS 11138-7 [Under development]
Sterilization of health care products -- Biological indicators -- Part 7: Guidance for the selection, use and interpretation of results
40.20
ISO/DIS 11139 [Under development]
Sterilization of health care products -- Vocabulary -- Terms used in sterilization and related equipment and process standards
40.60
ISO/TS 11139:2001 [Withdrawn]
Sterilization of health care products -- Vocabulary
95.99
ISO/TS 11139:2006
Sterilization of health care products -- Vocabulary
90.92
ISO 11140-1:1995 [Withdrawn]
Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
95.99
95.99
ISO 11140-1:2005 [Withdrawn]
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 [Withdrawn]
Sterilization of health care products -- Chemical indicators -- Part 2: Test equipment and methods
95.99
ISO 11140-3:2000 [Withdrawn]
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
60.60
ISO 11140-4:2001 [Withdrawn]
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 [Withdrawn]
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 [Under development]
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 11607:1997 [Withdrawn]
Packaging for terminally sterilized medical devices
95.99
ISO 11607:2003 [Withdrawn]
Packaging for terminally sterilized medical devices
95.99
ISO 11607-1:2006
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
90.92
60.60
ISO/DIS 11607-1 [Under development]
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
40.20
ISO 11607-2:2006
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
90.92
60.60
ISO/DIS 11607-2 [Under development]
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
40.20
ISO 11737-1 [Under development]
Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
60.00
ISO 11737-1:1995 [Withdrawn]
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
90.92
60.60
ISO 11737-2:1998 [Withdrawn]
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/CD 11737-2 [Under development]
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
30.20
ISO 11737-3:2004 [Withdrawn]
Sterilization of medical devices -- Microbiological methods -- Part 3: Guidance on evaluation and interpretation of bioburden data
95.99
ISO/TS 13004:2013
Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD
90.93
ISO 13408-1:1998 [Withdrawn]
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
90.93
60.60
ISO 13408-2:2003
Aseptic processing of health care products -- Part 2: Filtration
90.92
ISO/FDIS 13408-2 [Under development]
Aseptic processing of health care products -- Part 2: Sterilizing filtration
50.20
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
60.60
ISO/NP 13408-6 [Under development]
Aseptic processing of health care products -- Part 6: Isolator systems
10.99
ISO 13408-7:2012
Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
90.20
ISO/TR 13409:1996 [Withdrawn]
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 [Withdrawn]
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 [Withdrawn]
Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
95.99
ISO 14160:1998 [Withdrawn]
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/NP 14160 [Under development]
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
10.99
ISO 14161:2000 [Withdrawn]
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
90.93
ISO/CD 14161 [Deleted]
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
30.98
ISO 14937:2000 [Withdrawn]
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
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 [Withdrawn]
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 [Withdrawn]
Sterilization of health care products -- Radiation sterilization -- Selection of sterilization dose for a single production batch
95.99
ISO 15882:2003 [Withdrawn]
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
60.60
ISO/NP 15883-1 [Under development]
Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests
10.99
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
90.92
ISO/DIS 15883-4 [Under development]
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
40.60
ISO/CD 15883-5 [Under development]
Washer disinfectors -- Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
30.60
ISO/TS 15883-5:2005
Washer-disinfectors -- Part 5: Test soils and methods for demonstrating cleaning efficacy
90.92
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 16342 [Under development]
Sterilization of health care products -- Biological indicators -- Method for validation of a biological indicator incubation period
30.60
ISO/TS 16775:2014
Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2
90.60
ISO 17664:2004 [Withdrawn]
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 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/NP 17665-1 [Under development]
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
10.99
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
90.93
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
90.92
ISO/DIS 18472 [Under development]
Sterilization of health care products -- Biological and chemical indicators -- Test equipment
40.99
ISO/DTS 19572 [Under development]
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
30.92
ISO/TS 19930 [Under development]
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
60.00
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/NP TS 21387 [Under development]
Sterilization of medical devices -- Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
10.99
ISO/NP TS 22421 [Under development]
Sterilization of health care products -- Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities
10.99
ISO/NP 22441 [Under development]
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/NP TS 22456 [Under development]
Sterilization of healthcare products -- Microbiological Methods-- Guidance on conducting bioburden determinations and tests of sterility for tissue-based products
10.99
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
90.92
ISO/FDIS 25424 [Under development]
Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
50.00

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