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List of Recognized Standardsfor Medical DevicesDate adopted: 2002/04/11Revised date: 2021/05/07Effective date: 2021/05/07

Health Canada is responsible for helping Canadians maintain and improve their health. Itensures that high-quality health services are accessible, and works to reduce health risks.Également disponible en français sous le titre :Normes reconnues pour les instruments médicaux Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2021Publication date: May 2021This publication may be reproduced for personal or internal use only without permissionprovided the source is fully acknowledged.List of Recognized Standards for Medical Devices 2

ForewordGuidance documents are meant to provide assistance to industry and health care professionalson how to comply with governing statutes and regulations. Guidance documents also provideassistance to staff on how Health Canada mandates and objectives should be implemented in amanner that is fair, consistent, and effective.Guidance documents are administrative instruments not having force of law and, as such, allowfor flexibility in approach. Alternate approaches to the principles and practices described in thisdocument may be acceptable provided they are supported by adequate justification. Alternateapproaches should be discussed in advance with the relevant programme area to avoid thepossible finding that applicable statutory or regulatory requirements have not been met.As a corollary to the above, it is equally important to note that Health Canada reserves the rightto request information or material, or define conditions not specifically described in thisdocument, in order to allow the Department to adequately assess the safety, efficacy, or qualityof a therapeutic product. Health Canada is committed to ensuring that such requests arejustifiable and that decisions are clearly documented.This document should be read in conjunction with the accompanying notice and the relevantsections of other applicable Guidance documents.List of Recognized Standards for Medical Devices 3

Table of contentsChanges to the List of Recognized Standards . 5Standards Added . 5Standards Updated. 6Standards Removed . 9List of Recognized Standards . 9Anaesthetic and Respiratory . 9Biocompatibility . 11Cardiovascular . 13Contraception . 15Dental . 15Electromedical . 17General . 23In Vitro Diagnostic . 25Manufacturing . 28Materials . 30Neurology . 35Ophthalmology . 35Orthopaedics . 37Radiology . 42Sterilization. 43List of Recognized Standards for Medical Devices 4

Changes to the List of Recognized StandardsStandards AddedISO 25539-2:2012-Ed.2.0Cardiovascular implants - Endovascular devices - Part 2: Vascular stentsISO 13116:2014-Ed.1.0Dentistry — Test Method for Determining Radio-Opacity of MaterialsISO 29022:2013-Ed.1.0Dentistry — Adhesion — Notched-edge shear bond strength testIEC 60601-2-1:2014-Ed.3.1Medical electrical equipment - Part 2-1: Particular requirements for the basic safetyand essential performance of electron accelerators in the range 1 MeV to 50 MeVIEC 62366-1:2015-Ed.1.0Medical devices - Part 1: Application of usability engineering to medical devicesIEC 62366-1/COR 1:2016ASTM F2026-16Standard specification for polyetheretherketone (PEEK) polymers for surgicalimplant applicationsISO 11979-4:2008-Ed.2.0Ophthalmic implants - Intraocular lenses - Part 4: Labelling and informationISO 11979-4/Amd.1:2012ISO 11979-10:2018-Ed.2.0Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations ofintraocular lenses for correction of ametropia in phakic eyesISO TR 22979:2017-Ed.2.0Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need forclinical investigation of intraocular lens design modificationsASTM F2083-12Standard specification for knee replacement prosthesisASTM F2346-11Standard test methods for static and dynamic characterization of spinal artificialdiscsList of Recognized Standards for Medical Devices 5

ASTM F3140-17Standard test method for cyclic fatigue testing of metal tibial tray components ofunicondylar knee joint replacementsASTM F543-17Standard Specification and Test Methods for Metallic Medical Bone ScrewsIEC 60601-2-45:2015-Ed.3.1Medical electrical equipment – Part 2-45: Particular requirements for the basicsafety and essential performance of mammographic X-ray equipment andmammographic stereotactic devicesStandards UpdatedISO 7199:2016-Ed.3.0Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)ISO 10993-1:2018-Ed.5.0Biological evaluation of medical devices – Part 1: Evaluation and testing within a riskmanagement processNote: Devices subject to Clause 5.3.2 may require additional testing beyond thatwhich is specified in Clause 5.3.2ISO 10555-1:2013-Ed.2.0Intravascular catheters - Sterile and single-use catheters - Part 1: GeneralrequirementsISO 10555-1/Amd.1:2017ISO 25539-1:2017-Ed.2.0Cardiovascular implants – Endovascular devices – Part 1: Endovascular prosthesesISO 4049:2019-Ed.5.0Dentistry – Polymer-based restorative materialsISO 6872:2015-Ed.4.0Dentistry – Ceramic materialsISO 6872/Amd.1:2018ISO 6874:2015-Ed.3.0Dentistry – Polymer-based pit and fissure sealantsISO 7405:2018-Ed.3.0Dentistry – Evaluation of biocompatibility of medical devices used in dentistryList of Recognized Standards for Medical Devices 6

ISO 9917-2:2017-Ed.3.0Dentistry - Water-based cements – Part 2: Resin-modified cementsISO 14801:2016-Ed.3.0Dentistry — Implants — Dynamic loading test for endosseous dental implantsISO 22674:2016-Ed.2.0Dentistry – Metallic materials for fixed and removable restorations and appliancesISO 24234:2015-Ed.2.0Dentistry — Dental amalgamISO/TS 11405:2015-Ed.3.0Dental materials – Testing of adhesion to tooth structureIEC 60601-2-22:2012-Ed.3.1Medical electrical equipment – Part 2-22: Particular requirements for basic safetyand essential performance of surgical, cosmetic, therapeutic and diagnostic laserequipmentISO 14708-3:2017-Ed.2.0Implants for Surgery - Active implantable medical devices -- Part 3: ImplantableneurostimulatorsISO 11979-8:2017-Ed.3.0Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirementsASTM F1044-05Standard test method for shear testing of calcium phosphate coatings and metalliccoatingsASTM F1044-05/(R 2017)ASTM F1044-05/(E 2018)ASTM F1147-05Standard test method for tension testing of calcium phosphate and metal coatingsASTM F1147-05/(R 2017)ASTM F1147-05/(E 2017)ASTM F1717-18Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelASTM F1801-97Standard practice for corrosion fatigue testing of metallic implant materialsASTM F1801-97/(R 2014)List of Recognized Standards for Medical Devices 7

ASTM F2077-18Test Methods for Intervertebral Body Fusion DevicesASTM F2267-04Standard Test Method for Measuring Load Induced Subsidence of IntervertebralBody Fusion Device under Static Axial CompressionASTM F2267-04 /(R 2018)ASTM F746-04Standard test method for pitting or crevice corrosion of metallic surgical implantmaterialsASTM F746-04 /(R 2014)ISO 14242-1:2014-Ed.3.0Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading anddisplacement parameters for wear-testing machines and correspondingenvironmental conditions for testISO 14242-1/Amd. 1: 2018ISO 14242-2:2016-Ed.2.0Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods ofmeasurementISO 14243-2:2016-Ed.3.0Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods ofmeasurementISO 14243-3:2014-Ed.2.0Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading anddisplacement parameters for wear-testing machines with displacement control andcorresponding environmental conditions for testIEC 60601-2-28:2017-Ed.3.0Medical electrical equipment – Part 2-28: Particular requirements for the basicsafety and essential performance of X-ray tube assemblies for medical diagnosisIEC 60601-2-43:2017-Ed.2.1Medical electrical equipment – Part 2-43: Particular requirements for the basicsafety and essential performance of X-ray equipment for interventional proceduresIEC 60601-2-43/Amd.1:2017List of Recognized Standards for Medical Devices 8

ISO 11135:2014-Ed.2.0Sterilization of health care products – Ethylene oxide – Requirements for thedevelopment, validation and routine control of a sterilization process for medicaldevicesISO 11135/Amd.1:2018Standards RemovedISO 9693:1999Metal-ceramic dental restorative systemsISO 9693/Amd.1:2005IEC 60601-1-2:2007-Ed.3.0Medical electrical equipment – Part 1-2: General requirements for basic safety andessential performance – Collateral standard: Electromagnetic compatibility –Requirements and testsIEC 62366:2014-Ed.1.1Medical devices – Application of usability engineering to medical devicesOther modificationsA neurology section was added, which lists neurology specific standards under a separatesection.List of Recognized StandardsAnaesthetic and RespiratoryASME PVHO-1:2007Safety standard for pressure vessels for human occupancyISO 5356-1:2015-Ed.4.0Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones andSocketsList of Recognized Standards for Medical Devices 9

ISO 5356-2:2012-Ed.3.0Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screwthreaded weight bearing connectorsISO 5360:2012-Ed.3.0Anaesthetic Vaporizers - Agent Specific Filling SystemISO 7199:2016-Ed.3.0Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)ISO 8359:1996-Ed.2.0Oxygen Concentrators for medical use - Safety requirementsISO 8359:1996-Ed.2.0/Amd.1:2012ISO 80601-2-12:2011-Ed.1.0Medical electrical equipment – Part 2-12: Particular requirements for basic safetyand essential performance of critical care ventilatorsISO 80601-2-12:2011-Ed.1.0/Cor.1:2011ISO 80601-2-13:2011-Ed.1.0Medical electrical equipment – Part 2-13: Particular requirements for basic safetyand essential performance of an anaesthetic workstationISO 80601-2-13:2011-Ed.1.0/Amd.1:2015ISO 80601-2-55:2011-Ed.1.0Medical electrical equipment – Part 2-55: Particular requirements for the basicsafety and essential performance of respiratory gas monitorsISO 80601-2-61:2011-Ed.1.0Medical electrical equipment – Part 2-61: Particular requirements for basic safetyand essential performance of pulse oximeter equipmentList of Recognized Standards for Medical Devices 10

ISO 80601-2-72:2015-Ed.1.0Medical electrical equipment – Part 2-72: Particular requirements for basic safetyand essential performance of home healthcare environment ventilators forventilator-dependent patientsBiocompatibilityASTM F981-04Standard practice for assessment of compatibility of biomaterials for surgicalimplants with respect to effect of materials on muscle and boneISO 10993-1:2018-Ed.5.0Biological evaluation of medical devices – Part 1: Evaluation and testing within a riskmanagement processNote: Devices subject to Clause 5.3.2 may require additional testing beyond thatwhich is specified in Clause 5.3.2ISO 10993-2:2006-Ed.2.0Biological evaluation of medical devices – Part 2: Animal welfare requirementsISO 10993-3:2003-Ed.2.0Biological evaluation of medical devices – Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicityISO 10993-4:2002-Ed.2.0Biological evaluation of medical devices – Part 4: Selection of tests for interactionswith bloodISO 10993-4:2002-Ed.2.0/Amd.1:2006ISO 10993-5:2009-Ed.3.0Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicityISO 10993-6:2007-Ed.2.0Biological evaluation of medical devices – Part 6: Tests for local effects afterimplantationList of Recognized Standards for Medical Devices

List of Recognized Standards for Medical Devices 9 ISO 11135:2014-Ed.2.0 Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 11135/Amd.1:2018 Standards Removed ISO 9693:1999 Metal-ceramic dental restorative systems