Codes & Standards
CAN/CSA-Z11137-1-07 (R2021)
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11137-1:2006, first edition, 2006-04-15)
- English, French
- Published in 2007
- Reaffirmed in 2021
- Published by CSA Group
- Subscription Available
Codes & Standards
CAN/CSA-Z11137-1-07 (R2021)/A2:22
Amendment 2:2022 to CAN/CSA-Z11137-1-07, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Adopted amendment 2:2018 to ISO 11137-1:2006)
- English, French
- Published in 2022
- Published by CSA Group
Codes & Standards
CSA ISO 11139:19
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards (Adopted ISO 11139:2018, first edition, 202018-08)
- English, French
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO 11737-1:19
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted ISO 11737-1:2018, third edition, 2018-01)
- English, French
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO 11737-2:21
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (Adopted ISO 11737-2:2019, third edition, 2019-12)
- English, French
- Published in 2021
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO 15883-4:19
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (Adopted ISO 15883-4:2018, second edition, 2018-11)
- English, French
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO 17664-1:23
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)
- English, French
- Published in 2023
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO 17664-2:23
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 (Adopted ISO 17664-2:2021, first edition, 2021-02)
- English, French
- Published in 2023
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO 20857:19
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 20857:2010, first edition, 2010-08-15
- English, French
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA ISO/TS 11137-4:21
Sterilization of health care products — Radiation — Part 4: Guidance on process control (Adopted ISO technical specification 11137-4:2020, first edition, 2020-06)
- English
- Published in 2021
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z11138-7:21
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results (Adopted ISO 11138-7:2019, with Canadian deviations)
- English, French
- Published in 2021
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z15882:09 (R2019)
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)
- English, French
- Published in 2009
- Reaffirmed in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z17665-1:09 (R2019)
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
- English, French
- Published in 2009
- Reaffirmed in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z17665-2:09 (R2019)
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
- English, French
- Published in 2009
- Reaffirmed in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z317.12:20
Cleaning and disinfection of health care facilities
- English, French
- Published in 2020
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z317.13:22
Infection control during construction, renovation, and maintenance of health care facilities
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
- Available as CSA Advantage™
Codes & Standards - Purchase
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
- English, French
- Published in 2014
- Published by ISO
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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
- English, French
- Published in 2018
- Published by ISO
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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
- English, French
- Published in 2006
- Published by ISO
Codes & Standards - Purchase
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
- English, French
- Published in 2013
- Published by ISO
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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
- English, French
- Published in 2018
- Published by ISO
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ISO 11137-2:2013
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- English, French
- Published in 2013
- Published by ISO
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ISO 11137-2:2013/Amd 1:2022
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
- English, French
- Published in 2022
- Published by ISO
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ISO 11137-3:2017
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects of development, validation and routine control
- English, French
- Published in 2017
- Published by ISO
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ISO 11138-1:2017
Sterilization of health care products — Biological indicators — Part 1: General requirements
- English, French
- Published in 2017
- Published by ISO
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ISO 11138-2:2017
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
- English, French
- Published in 2017
- Published by ISO
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ISO 11138-3:2017
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
- English, French
- Published in 2017
- Published by ISO
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ISO 11138-4:2017
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
- English, French
- Published in 2017
- Published by ISO
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ISO 11138-5:2017
Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- English, French
- Published in 2017
- Published by ISO
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ISO 11138-7:2019
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
- English, French
- Published in 2019
- Published by ISO
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ISO 11138-8:2021
Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator
- English, French
- Published in 2021
- Published by ISO
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ISO 11139:2018
Sterilization of health care products -- Vocabulary of terms used in sterilization and related equipment and process standards
- English, French
- Published in 2018
- Published by ISO
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ISO 11140-1:2014
Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
- English, French
- Published in 2014
- Published by ISO
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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
- English, French
- Published in 2007
- Published by ISO
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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
- English
- Published in 2007
- Published by ISO
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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
- English, French
- Published in 2007
- Published by ISO
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ISO 11140-5:2007
Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
- English, French
- Published in 2007
- Published by ISO
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ISO 11140-6:2022
Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
- English, French
- Published in 2022
- Published by ISO
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ISO 11737-1:2018
Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
- English, French
- Published in 2018
- Published by ISO
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ISO 11737-1:2018/Amd 1:2021
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
- English, French
- Published in 2021
- Published by ISO
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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
- English, French
- Published in 2009
- Published by ISO
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ISO 11737-3:2023
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
- English, French
- Published in 2023
- Published by ISO
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ISO 13004:2022
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
- English, French
- Published in 2022
- Published by ISO
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ISO 13408-2:2018
Aseptic processing of health care products -- Part 2: Sterilizing filtration
- English, French
- Published in 2018
- Published by ISO
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ISO 13408-3:2006
Aseptic processing of health care products -- Part 3: Lyophilization
- English, French
- Published in 2006
- Published by ISO
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ISO 13408-4:2005
Aseptic processing of health care products -- Part 4: Clean-in-place technologies
- English, French
- Published in 2005
- Published by ISO
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ISO 13408-5:2006
Aseptic processing of health care products -- Part 5: Sterilization in place
- English, French
- Published in 2006
- Published by ISO