Codes and Standards Codes and Standards

CSA ISO 17665:25

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665:2024, first edition, 2024-03)

Published: 2025, CSA Group
Associated Standard: ISO 17665
Language: English, French
Format: PDF
Training Training

Foundations of Standards Literacy

Using Standards to Access Best Practices, Guidelines, and Minimum Requirements When Required
Published: 2024, CSA Group
Language: English, French
Format: Self-Paced Online
Codes and Standards Codes and Standards

CSA ISO 10079-2:24

Medical suction equipment - Part 2: Manually powered suction equipment (Adopted ISO 10079-2:2022, fourth edition, 2022-03)

Published: 2024, CSA Group
Associated Standard: ISO 10079-2
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA Z10651-4:24

Lung ventilators — Part 4: Particular requirements for user- powered resuscitators (Adopted ISO 10651-4:2023, second edition, 2023-03, with Canadian deviations)

Published: 2024, CSA Group
Associated Standard: Z10651-4
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 5361:24

Anaesthetic and respiratory equipment — Tracheal tubes and connectors (Adopted ISO 5361:2023, fourth edition, 2023-01; corrected version; 2023-11)

Published: 2024, CSA Group
Associated Standard: ISO 5361
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 16628:24

Anaesthetic and respiratory equipment — Tracheobronchial tubes (Adopted ISO 16628:2022, second edition, 2022-06)

Published: 2024, CSA Group
Associated Standard: ISO 16628
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 10079-3:24

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2024, fourth edition, 2022-03)

Published: 2024, CSA Group
Associated Standard: ISO 10079-3
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 27427:24

Anaesthetic and respiratory equipment - Nebulizing systems and components (Adopted ISO 27427:2023, fourth edition, 2023-07)

Published: 2024, CSA Group
Associated Standard: ISO 27427
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 10079-1:24

Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2022, fourth edition, 2022-03)

Published: 2024, CSA Group
Associated Standard: ISO 10079-1
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA Z7001:24

Safe use of energy-based medical and surgical devices in health care

Published: 2024, CSA Group
Associated Standard: Z7001
Language: English
Format: PDF
Codes and Standards Codes and Standards

CSA Z18778:24

Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (Adopted ISO 18778:2022, second edition, 2022-06, with Canadian deviations)

Published: 2024, CSA Group
Associated Standard: Z18778
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 11712:24

Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2023, second edition, 2023-11)

Published: 2024, CSA Group
Associated Standard: ISO 11712
Language: English
Format: PDF
Codes and Standards Codes and Standards

CSA Z364.6:23

Quality management for kidney dialysis providers

Published: 2023, CSA Group
Associated Standard: Z364.6
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

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)

Published: 2023, CSA Group
Associated Standard: ISO/TS 16775
Language: English
Format: PDF
Codes and Standards Codes and 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)

Published: 2023, CSA Group
Associated Standard: ISO 17664-1
Language: English, French
Format: PDF
Codes and Standards Codes and 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)

Published: 2023, CSA Group
Associated Standard: ISO 17664-2
Language: English, French
Format: PDF
Amendments, Redlines, Supplementary Amendments, Redlines, Supplementary

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)

Published: 2022, CSA Group
Associated Standard: Z11137-1/A2:22
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

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)
Published: 2022, CSA Group
Associated Standard: IEC 62366-1
Language: Bilingual
Format: PDF
Codes and Standards Codes and Standards

CSA Z364.5:22

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

Published: 2022, CSA Group
Associated Standard: Z364.5
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 15190:21

Medical laboratories - Requirements for safety (Adopted ISO 15190:2020, second edition, 2020-02)

Published: 2021, CSA Group
Associated Standard: ISO 15190
Language: English
Format: PDF