Codes & Standards
CAN/CSA-C22.2 NO. 60601-1-8:08 (R2023)
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10)
- Bilingual
- Published in 2008
- Reaffirmed in 2023
- Published by CSA Group
- Subscription Available
Codes & Standards
CAN/CSA-C22.2 NO. 60601-1-8:08 + A1:14 + A2:21 (R2023) (CONSOLIDATED)
Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, edition 2:2006 consolidated with amendment 1:2012 and amendment 2:2020, with Canadian deviations) | Appareils électromédicaux — Partie 1-8 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Exigences générales, essais et guide pour les systèmes d’alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, édition 2:2006 consolidée par l’amendement 1:2012 et l’amendement 2:2020, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Reaffirmed in 2023
- Published by CSA Group
Codes & Standards
CAN/CSA-C22.2 NO. 60601-1-8:08/A2:21 (R2023)
Amendment 2:2021 to CAN/CSA-C22.2 NO. 60601-1-8:08, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted amendment 2:2020 to IEC 60601-1-8:2006)
- English, French
- Published in 2021
- Reaffirmed in 2023
- Published by CSA Group
Codes & Standards
CAN/CSA-C22.2 NO. 60601-1-9:15 (R2019) +A2:21 (CONSOLIDATED)
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design (Adopted IEC 60601-1-9:2007, edition 1:2007 consolidated with amendment 1:2013 and amendment 2:2020, with Canadian deviations) | Appareils électromédicaux - Partie 1-9 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception écoresponsable (norme IEC 60601-1-9:2007 adoptée, édition 1:2007, consolidée par l'amendement 1:2013 et l'amendement 2:2020, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Reaffirmed in 2019
- Published by CSA Group
Codes & Standards
CAN/CSA-C22.2 NO. 60601-1-9B:15
Amendment 2:2021 to CAN/CSA-C22.2 NO. 60601-1-9:15, Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design (Adopted amendment 2:2020 to IEC 60601-1-9:2007) | Modification 2:2021 de CAN/CSA-C22.2 NO. 60601-2-9:15, Appareils électromédicaux - Partie 1-9 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception écoresponsable (amendement 2:2020 adoptée de la norme IEC 60601-1-9:2007)
- Bilingual
- Published in 2021
- Published by CSA Group
Codes & Standards
CAN/CSA-C22.2 NO. 60601-1:14 + A2:22 (R2022) (CONSOLIDATED)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, edition 3:2005 consolidated with amendment 1:2012 and amendment 2:2020, with Canadian deviations) | Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (norme IEC 60601-1:2005 adoptée, édition 3:2005 consolidée par l’amendement 1:2012 et l’amendement 2:2020, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Reaffirmed in 2022
- Published by CSA Group
Codes & Standards
CAN/CSA-C22.2 NO. 60601-1:14/A2:22 (R2022)
Amendment 2:2022 to CAN/CSA-C22.2 NO. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Adopted amendment 2:2020 to IEC 60601-1:2005, with Canadian deviations) | Modification 2:2022 à CAN/CSA-C22.2 NO. 60601-1:14, Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (amendement 2:2020 adoptée à la norme CEI 60601-1:2005, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Reaffirmed in 2022
- Published by CSA Group
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CAN/CSA-CEI/IEC 1289-1-98 (R2012)
High-Frequency Surgical Equipment - Part 1: Operation (Adopted CEI/IEC 1289-1:1994, first edition) / Appareils d'électrochirurgie à courant haute fréquence - Partie 1: Fonctionnement (norme CEI/IEC 1289-1:1994 adoptée, première édition)
- English, French
- Published in 1998
- Reaffirmed in 2012
- Published by CSA Group
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CAN/CSA-CEI/IEC 1289-2-98 (R2012)
High-Frequency Surgical Equipment - Part 2: Maintenance (Adopted CEI/IEC 1289-2:1994, first edition) / Appareils d'électrochirurgie à courant haute fréquence - Partie 2: Maintenance (norme CEI/IEC 1289-2:1994 adoptée, première édition)
- English, French
- Published in 1998
- Reaffirmed in 2012
- Published by CSA Group
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CAN/CSA-ISO/TR 14969-05 (R2015)
Medical Devices - Quality Management Systems - Guidance on the Application of ISO 13485:2003 (Adopted ISO/TR 14969:2004, first edition, 2004-10-15)
- English
- Published in 2005
- Reaffirmed in 2015
- Published by CSA Group
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CAN/CSA-Z264.2-99 (R2014)
Labelling of Drug Ampoules, Vials and Prefilled Syringes
- English, French
- Published in 1999
- Reaffirmed in 2014
- Published by CSA Group
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CAN/CSA-Z264.3-98 (R2010)
Standard for User-Applied Drug Labels in Anaesthesia and Critical Care
- English, French
- Published in 1998
- Reaffirmed in 2010
- Published by CSA Group
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CAN/CSA-Z604-03 (R2008)
Transportable Mobility Aids
- English, French
- Published in 2003
- Reaffirmed in 2008
- Published by CSA Group
Codes & Standards
CSA C22.2 NO. 60601-1-10:09 + A1:14 (R2020) + A2:21 (CONSOLIDATED)
Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Adopted IEC 60601-1-10:2007, edition 1:2007 consolidated with amendment 1:2013 and amendment 2:2020, with Canadian deviations) | Appareils électromédicaux — Partie 1-10 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Exigences pour le développement des régulateurs physiologiques en boucle fermée (norme IEC 60601-1-10:2007 adoptée, édition 1:2007 consolidée par l’amendement 1:2013 et l’amendement 2:2020, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Reaffirmed in 2020
- Published by CSA Group
Codes & Standards
CSA C22.2 NO. 60601-1-2:16 (R2021) + A1:22 (CONSOLIDATED)
Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests (Adopted IEC 60601-1-2:2014, edition 4:2014 consolidated with amendment 1:2020, with Canadian deviations) | Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Perturbations électromagnétiques — Exigences et essais (norme IEC 60601-1-2:2014 adoptée, édition 4:2014 consolidée par l’amendement 1:2020, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Reaffirmed in 2021
- Published by CSA Group
Codes & Standards
CSA C22.2 NO. 60601-1-2:16/A1:22
Amendment 1:2022 to CSA C22.2 NO. 60601-1-2:16, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests (Adopted amendment 1:2020 to IEC 60601-1-2:2014) | Modification 1:2022 à CSA C22.2 NO. 60601-1-2:16, Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Perturbations électromagnétiques — Exigences et essais (amendement 1:2020 adoptée à la norme IEC 60601-1-2:2014)
- Bilingual
- Published in 2022
- Published by CSA Group
Codes & Standards
CSA C22.2 NO. 60601-2-31:20
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Adopted IEC 60601-2-31:2020, third edition, 2020-01, with Canadian deviations) | Appareils électromédicaux - Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne (norme IEC 60601-2-31:2020 adoptée, troisième edition, 2020-01, avec exigences propres au Canada)
- Bilingual
- Published in 2020
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA C22.2 NO. 60601-2-35:22
Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use (Adopted IEC 60601-2-35:2020, second edition, 2020-09, with Canadian deviations) | Appareils électromédicaux — Partie 2-35 : Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas et destinés au réchauffage des patients en usage médical (norme IEC 60601-2-35:2020 adoptée, deuxième édition, 2020-09, avec exigences propres au Canada)
- Bilingual
- Published in 2022
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA C22.2 NO. 80601-2-26:23
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Adopted IEC 80601-2-26:2019, first edition, 2019-05, with Canadian deviations) | Appareils électromédicaux — Partie 2-26 : Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes (norme IEC 80601-2-26:2019 adoptée, première édition, 2019-05, avec exigences propres au Canada)
- Bilingual
- Published in 2023
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA C22.2 NO. 80601-2-30:19
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2018, second edition, 2018-03) | Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques (norme IEC 80601-2-30:2018 adoptée, deuxième édition, 2018-03)
- Bilingual
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA C22.2 NO. 80601-2-60:23
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (Adopted IEC 80601-2-60:2019, second edition, 2019-06, with Canadian deviations) | Appareils électromédicaux - Partie 2-60 : Exigences particulières pour la sécurité de base et les performances essentielles des équipements dentaires (norme IEC 80601-2-60:2019 adoptée, deuxième édition, 2019-06, avec exigences propres au Canada)
- Bilingual
- Published in 2023
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA C22.2 NO. 80601-2-77:19
Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Adopted IEC 80601-2-77:2019, first edition, 2019-07, with Canadian deviations) | Appareils électromédicaux — Partie 2-77 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés (norme IEC 80601-2-77:2019 adoptée, première édition, 2019-07, avec exigences propres au Canada)
- Bilingual
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA C22.2 NO. 80601-2-78:19
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (Adopted IEC 80601-2-78:2019, first edition, 2009-01, with Canadian deviations) | Appareils électromédicaux — Partie 2-78 : Exigences particulières pour la sécurité de base et les performances essentielles des robots médicaux dédiés à la rééducation, l'évaluation, la compensation ou l'atténuation (norme IEC 80601-2-78:2019 adoptée, première édition, 2019-07, avec exigences propres au Canada)
- Bilingual
- Published in 2019
- Published by CSA Group
- Subscription Available
Codes & 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) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux (norme IEC 62366-1:2015 adoptée, édition 1:2015 consolidée par l’amendement 1:2020)
- Bilingual
- Published in 2022
- Reaffirmed in 2020
- Published by CSA Group
Codes & Standards
CSA ISO/TR 24971:21
Medical devices — Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)
- English, French
- Published in 2021
- Published by CSA Group
- Subscription Available
Codes & Standards
CSA Z364.5:22
Safe installation and operation of haemodialysis and peritoneal dialysis in a home setting
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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IEC 60601-1-10:2007
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- Bilingual
- Published in 2007
- Published by IEC
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IEC 60601-1-10:2007+AMD1:2013 CSV
Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
- Bilingual
- Published in 2013
- Published by IEC
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IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 CSV
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-10:2007/AMD1:2013
Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- Bilingual
- Published in 2013
- Published by IEC
Codes & Standards - Purchase
IEC 60601-1-10:2007/AMD2:2020
Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-11:2015
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Bilingual
- Published in 2015
- Published by IEC
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IEC 60601-1-11:2015 RLV
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- English
- Published in 2015
- Published by IEC
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IEC 60601-1-11:2015+AMD1:2020 CSV
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-11:2015/AMD1:2020
Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-12:2014
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- Bilingual
- Published in 2014
- Published by IEC
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IEC 60601-1-12:2014+AMD1:2020 CSV
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-12:2014/AMD1:2020
Amendment 1 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Bilingual
- Published in 2014
- Published by IEC
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IEC 60601-1-2:2014+AMD1:2020 CSV
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- English, French
- Published in 2020
- Published by IEC
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IEC 60601-1-2:2014/AMD1:2020
Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- English, French
- Published in 2020
- Published by IEC
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IEC 60601-1-6:2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Bilingual
- Published in 2010
- Published by IEC
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IEC 60601-1-6:2010+AMD1:2013 CSV
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Bilingual
- Published in 2013
- Published by IEC
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IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-6:2010/AMD1:2013
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Bilingual
- Published in 2013
- Published by IEC
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IEC 60601-1-6:2010/AMD2:2020
Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Bilingual
- Published in 2020
- Published by IEC
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IEC 60601-1-8:2006
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- Bilingual
- Published in 2006
- Published by IEC