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Health Care Technology

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.

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Long-term care home operations and infection prevention and control

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Safe installation and operation of haemodialysis and peritoneal dialysis in a home setting

Lymphohematopoietic cells for transplantation

CAN/CSA-Z900.2.5:22

Lymphohematopoietic cells for transplantation

Ocular tissues for transplantation

CAN/CSA-Z900.2.4:22

Ocular tissues for transplantation

Perfusable organs for transplantation

CAN/CSA-Z900.2.3:22

Perfusable organs for transplantation

Tissues for transplantation

CAN/CSA-Z900.2.2:22

Tissues for transplantation

Cells, tissues, and organs for transplantation: General requirements

CAN/CSA-Z900.1:22

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

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)

Functional requirements and core data set for a Canadian paramedic information system (CPIS)

Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, edition 1:2015 consolidated with amendment 1:2020)

CSA IEC 62366-1:15 (R2020) + A1:21 (CONSOLIDATED)

Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, edition 1:2015 consolidated with amendment 1:2020)

Amendment 1:2021 to CSA IEC 62366-1:15, Medical devices — Part 1: Application of usability engineering to medical devices (Adopted amendment 1:2020 to IEC 62366-1:2015)

CSA IEC 62366-1A:15

Amendment 1:2021 to CSA IEC 62366-1:15, Medical devices — Part 1: Application of usability engineering to medical devices (Adopted amendment 1:2020 to IEC 62366-1:2015)

Medical devices — Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)

CSA ISO/TR 24971:21

Medical devices — Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)

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