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    Health Care and Medical Devices

    CSA began as the Canadian Engineering Standards Association (CESA) in 1919, federally chartered to create standards.

    For 100 years, CSA has remained an organization dedicated to safety, sustainability, and social good. From developing standards for aircraft parts, bridges, and wire rope in 1919, to enhancing standards with over 70,000 global members.

    Showing 1 to 25 of 156

    Export Results
    Anaesthetic and respiratory equipment — Tracheal tubes and connectors (Adopted ISO 5361:2023, fourth edition, 2023-01; corrected version; 2023-11)
    CSA ISO 5361:24 forword
    Anaesthetic and respiratory equipment — Tracheal tubes and connectors (Adopted ISO 5361:2023, fourth edition, 2023-01; corrected version; 2023-11)
    Requirements for the collection and transport of samples for medical laboratory examinations (Adopted ISO 20658:2023, first edition, 2023-05)
    CSA ISO 20658:24 forword
    Requirements for the collection and transport of samples for medical laboratory examinations (Adopted ISO 20658:2023, first edition, 2023-05)
    Special requirements for digital infrastructure and digital health care technologies in Canadian health care facilities
    CSA Z8005:24 forword
    Special requirements for digital infrastructure and digital health care technologies in Canadian health care facilities
    Long-term care home operations and infection prevention and control
    CSA Z8004:22 forword
    Long-term care home operations and infection prevention and control
    Amendment 1:2023 to CSA ISO 11737-1:19, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted amendment 1:2021 to ISO 11737-1:2018)
    CSA ISO 11737-1:19/A1:23 forword
    Amendment 1:2023 to CSA ISO 11737-1:19, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted amendment 1:2021 to ISO 11737-1:2018)
    Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (Adopted ISO 15883-5:2021, first edition, 2021-07)
    CSA ISO 15883-5:23 forword
    Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (Adopted ISO 15883-5:2021, first edition, 2021-07)
    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)
    CSA ISO 17664-1:23 forword
    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)
    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)
    CSA ISO 17664-2:23 forword
    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)
    Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO Technical Specification 16775:2021, second edition, 2021-11)
    CSA ISO/TS 16775:23 forword
    Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO Technical Specification 16775:2021, second edition, 2021-11)
    Quality management for kidney dialysis providers
    CSA Z364.6:23 forword
    Quality management for kidney dialysis providers
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma (Adopted ISO 20186-3:2019, first edition, 2019-09)
    CSA ISO 20186-3:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma (Adopted ISO 20186-3:2019, first edition, 2019-09)
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA (Adopted ISO 20186-2:2019, first edition, 2019-02)
    CSA ISO 20186-2:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA (Adopted ISO 20186-2:2019, first edition, 2019-02)
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA (Adopted ISO 20186-1:2019, first edition, 2019-02)
    CSA ISO 20186-1:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA (Adopted ISO 20186-1:2019, first edition, 2019-02)
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques (Adopted ISO 20166-4:2021, first edition, 2021-07)
    CSA ISO 20166-4:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques (Adopted ISO 20166-4:2021, first edition, 2021-07)
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA (Adopted ISO 20166-3:2018, first edition, 2018-12)
    CSA ISO 20166-3:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA (Adopted ISO 20166-3:2018, first edition, 2018-12)
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins (Adopted ISO 20166-2:2018, first edition, 2018-12)
    CSA ISO 20166-2:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins (Adopted ISO 20166-2:2018, first edition, 2018-12)
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA (Adopted ISO 20166-1:2018, first edition, 2018-12)
    CSA ISO 20166-1:22 forword
    Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA (Adopted ISO 20166-1:2018, first edition, 2018-12)
    Safe installation and operation of haemodialysis and peritoneal dialysis in a home setting
    CSA Z364.5:22 forword
    Safe installation and operation of haemodialysis and peritoneal dialysis in a home setting
    Lymphohematopoietic cells for transplantation
    CAN/CSA-Z900.2.5:22 forword
    Lymphohematopoietic cells for transplantation
    Ocular tissues for transplantation
    CAN/CSA-Z900.2.4:22 forword
    Ocular tissues for transplantation
    Perfusable organs for transplantation
    CAN/CSA-Z900.2.3:22 forword
    Perfusable organs for transplantation
    Tissues for transplantation
    CAN/CSA-Z900.2.2:22 forword
    Tissues for transplantation
    Cells, tissues, and organs for transplantation: General requirements
    CAN/CSA-Z900.1:22 forword
    Cells, tissues, and organs for transplantation: General requirements
    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)
    CAN/CSA-Z11137-1-07 (R2021)/A2:22 forword
    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)
    Functional requirements and core data set for a Canadian paramedic information system (CPIS)
    CSA Z1635:22 forword
    Functional requirements and core data set for a Canadian paramedic information system (CPIS)
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