Documentation:DatabaseRegsCodesStandards/MedicalDevicesCanada
| Title | Year/revision | Govt. Level | Governing agency | Link | Remarks |
|---|---|---|---|---|---|
| Anaesthetic and Respiratory | List of Recognized Standards for Medical Devices - Health Canada | ||||
| Safety standard for pressure vessels for human occupancy | 2022 | Federal | Health Canada | ASME PVHO-1:2007 | |
| Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets | 2021 | Federal | Health Canada | ISO 5356-1:2015-Ed.4.0 | |
| Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw threaded | 2022 | Federal | Health Canada | ISO 5356-2:2012-Ed.3.0 | |
| Anaesthetic Vaporizers - Agent Specific Filling System | 2022 | Federal | Health Canada | ISO 5360:2012-Ed.3.0 | |
| Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) | 2022 | Federal | Health Canada | ISO 7199:2016-Ed.3.0 | |
| Oxygen Concentrators for medical use - Safety requirements | 2022 | Federal | Health Canada | ISO 8359:1996-Ed.2.0 | |
| Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2022 | Federal | Health Canada | ISO 80601-2-12:2011-Ed.1.0 | |
| Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation | 2022 | Federal | Health Canada | ISO 80601-2-13:2011-Ed.1.0 | |
| Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | 2022 | Federal | Health Canada | ISO 80601-2-55:2011-Ed.1.0 | |
| Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | 2022 | Federal | Health Canada | ISO 80601-2-61:2011-Ed.1.0 | |
| Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients | 2022 | Federal | Health Canada | ISO 80601-2-72:2015-Ed.1.0 | |
| Standard practice for assessment of compatibility of biomaterials for surgical implants with | 2022 | Federal | Health Canada | ASTM F981-04 | |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | 2022 | Federal | Health Canada | ISO 10993-1:2018-Ed.5.0 | |
| Biological evaluation of medical devices - Part 2: Animal welfare requirements | 2022 | Federal | Health Canada | ISO 10993-2:2006-Ed.2.0 | |
| Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | 2022 | Federal | Health Canada | ISO 10993-3:2014-Ed.3.0 | |
| Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | 2022 | Federal | Health Canada | ISO 10993-4:2017-Ed.3.0 | |
| Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | 2022 | Federal | Health Canada | ISO 10993-5:2009-Ed.3.0 | |
| Biological evaluation of medical devices - Part 6: Tests for local effects after implantation | 2022 | Federal | Health Canada | ISO 10993-6:2016-Ed.3.0 | |
| Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | 2022 | Federal | Health Canada | ISO 10993-7:2008-Ed.2.0 | |
| Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | 2022 | Federal | Health Canada | ISO 10993-9:2019-Ed.3.0 | |
| Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | 2022 | Federal | Health Canada | ISO 10993-10:2010-Ed.3.0 | |
| Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | 2022 | Federal | Health Canada | ISO 10993-11:2017-Ed.3.0 | |
| Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | 2022 | Federal | Health Canada | ISO 10993-12:2007-Ed.3.0 | |
| Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices | 2022 | Federal | Health Canada | ISO 10993-13:2010-Ed.2.0 | |
| Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics | 2022 | Federal | Health Canada | ISO 10993-14:2001-Ed.1.0 | |
| Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys | 2022 | Federal | Health Canada | ISO 10993-15:2019-Ed. | |
| Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements | 2022 | Federal | Health Canada | ISO 5840-1:2021-Ed.2.0 | |
| Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - Surgically implanted heart valve substitutes | 2022 | Federal | Health Canada | ISO 5840-2:2021-Ed.2.0 | |
| Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques | 2022 | Federal | Health Canada | ISO 5840-3:2021-Ed.2.0 | |
| Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers | 2022 | Federal | Health Canada | ISO 5841-3:2013-Ed.3.0 | |
| Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches | 2022 | Federal | Health Canada | ISO 7198:2016-Ed.2.0 | |
| Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | 2022 | Federal | Health Canada | ISO 10555-1:2013-Ed.2.0 | |
| Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters | 2022 | Federal | Health Canada | ISO 10555-3:2013-Ed.2.0 | |
| Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters | 2022 | Federal | Health Canada | ISO 10555-4:2013-Ed.2.0 | |
| Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters | 2022 | Federal | Health Canada | ISO 10555-5:2013-Ed.2.0 | |
| Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements | 2022 | Federal | Health Canada | ISO 11318:2002-Ed.2.0 | |
| Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements | 2022 | Federal | Health Canada | ISO 12417-1:2015-Ed.1.0 | |
| Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac | 2022 | Federal | Health Canada | ISO 14117:2019-Ed.2.0 | |
| Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers | 2022 | Federal | Health Canada | ISO 14708-2:2019-Ed.3.0 | |
| Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices | 2022 | Federal | Health Canada | ISO 14708-5:2020-Ed.2.0 | |
| Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including | 2022 | Federal | Health Canada | ISO 14708-6:2019-Ed.2.0 | |
| Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses | 2022 | Federal | Health Canada | ISO 25539-1:2017-Ed.2.0 | |
| Cardiovascular implants - Endovascular devices - Part 2: Vascular stents | 2022 | Federal | Health Canada | ISO 25539-2:2020-Ed.3.0 | |
| Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements | 2022 | Federal | Health Canada | ISO 27186:2020-Ed.2.0 | |
| Natural latex rubber condoms – Requirements and test methods | 2022 | Federal | Health Canada | ISO 4074:2002-Ed.1.0 | |
| Natural latex rubber condoms – Requirements and test methods | 2022 | Federal | Health Canada | ISO 4074:2002-Ed.1.0 | |
| Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements | 2022 | Federal | Health Canada | ISO 3107:2011-Ed.4.0 | |
| Dentistry - Polymer-based restorative materials | 2022 | Federal | Health Canada | ISO 4049:2019-Ed.5.0 | |
| Dentistry - Ceramic materials | 2022 | Federal | Health Canada | ISO 6872:2015-Ed.4.0 | |
| Dentistry - Polymer-based pit and fissure sealants | 2022 | Federal | Health Canada | ISO 6874:2015-Ed.3.0 | |
| Dental root canal sealing materials | 2022 | Federal | Health Canada | ISO 6876:2012-Ed.3.0 | |
| Dentistry - Root-canal obturating points | 2022 | Federal | Health Canada | ISO 6877:2006-Ed.2.0 | |
| Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | 2022 | Federal | Health Canada | ISO 7405:2018-Ed.3.0 | |
| Dentistry - Compatibility testing - Part 1: Metal-ceramic systems | 2022 | Federal | Health Canada | ISO 9693-1:2012-Ed.1.0 | |
| Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements | 2022 | Federal | Health Canada | ISO 9917-1:2007-Ed.2.0 | |
| Dentistry - Water-based cements - Part 2: Resin-modified cements | 2022 | Federal | Health Canada | ISO 9917-2:2017-Ed.3.0 | |
| Dental metallic materials - Corrosion test methods for metallic materials | 2022 | Federal | Health Canada | ISO 10271:2011-Ed.2.0 | |
| Dentistry — Implants — Dynamic loading test for endosseous dental implants | 2022 | Federal | Health Canada | ISO 14801:2016-Ed.3.0 | |
| Dentistry - Metallic materials for fixed and removable restorations and appliances | 2022 | Federal | Health Canada | ISO 22674:2016-Ed.2.0 | |
| Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file | 2022 | Federal | Health Canada | ISO 22794:2007-Ed.1.0 | |
| Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file | 2022 | Federal | Health Canada | ISO 22803:2004-Ed.1.0 | |
| Dentistry - Dental amalgam | 2022 | Federal | Health Canada | ISO 24234:2015-Ed.2.0 | |
| Dental materials - Testing of adhesion to tooth structure | 2022 | Federal | Health Canada | ISO/TS 11405:2015-Ed.3.0 | |
| Dentistry - Test Method for Determining Radio-Opacity of Materials | 2022 | Federal | Health Canada | ISO 13116:2014-Ed.1.0 | |
| Dentistry - Adhesion - Notched-edge shear bond strength test | 2022 | Federal | Health Canada | ISO 29022:2013-Ed.1.0 | |
| Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2022 | Federal | Health Canada | IEC 60601-1:2012-Ed.3.1 | |
| Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | 2022 | Federal | Health Canada | IEC 60601-1-2:2014-Ed.4.0 | |
| Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2022 | Federal | Health Canada | IEC 60601-1-6:2013-Ed.3.1 | |
| 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 | 2022 | Federal | Health Canada | IEC 60601-1-8:2012-Ed.2.1 | |
| 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 | 2022 | Federal | Health Canada | IEC 60601-1-10:2007-Ed 1.0 | |
| 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 | 2022 | Federal | Health Canada | IEC 60601-1-11:2010 -Ed 1.0 | |
| Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV | 2022 | Federal | Health Canada | IEC 60601-2-1:2014-Ed.3.1 | |
| Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | 2022 | Federal | Health Canada | IEC 60601-2-2:2009-Ed.5.0 | |
| Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators | 2022 | Federal | Health Canada | IEC 60601-2-4:2010-Ed.3.0 | |
| Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-5:2009-Ed.3.0 | |
| Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment | 2022 | Federal | Health Canada | IEC 60601-2-16:2008-Ed.3.0 | |
| Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | 2022 | Federal | Health Canada | IEC 60601-2-18:2009-Ed.3.0 | |
| Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | 2022 | Federal | Health Canada | IEC 60601-2-22:2012-Ed.3.1 | |
| Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment | 2022 | Federal | Health Canada | IEC 60601-2-23:2011-Ed.3.0 | |
| Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-24:2012-Ed.2.0 | |
| Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | 2022 | Federal | Health Canada | IEC 60601-2-25:2011-Ed.2.0 | |
| Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 2022 | Federal | Health Canada | IEC 60601-2-26:2012-Ed.3.0 | |
| Medical Electrical Equipment - Part 2-27: Particular Requirements for the Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment | 2022 | Federal | Health Canada | IEC 60601-2-27:2011-Ed.3.0 | |
| Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2022 | Federal | Health Canada | IEC 60601-2-31:2008-Ed.2.0 | |
| Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2022 | Federal | Health Canada | IEC 60601-2-33:2010-Ed.3.0 | |
| Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment | 2022 | Federal | Health Canada | IEC 60601-2-34:2011-Ed.3.0 | |
| Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy | 2022 | Federal | Health Canada | IEC 60601-2-36:2014-Ed.2.0 | |
| Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems | 2022 | Federal | Health Canada | IEC 60601-2-47 | |
| Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems | 2022 | Federal | Health Canada | IEC 60601-2-47:2012-Ed.2.0 | |
| Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-49:2011-Ed.2.0 | |
| Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-50:2009-Ed.2.0 | |
| Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-57:2011-Ed.1.0 | |
| Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-62:2013-Ed.1.0 | |
| Safety of laser products - Part 1: Equipment classification and requirements | 2022 | Federal | Health Canada | IEC 60825-1:2014-Ed.3.0 | |
| Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current | 2022 | Federal | Health Canada | IEC 61000-3-2:2009-Ed.3.2 | |
| Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, | 2022 | Federal | Health Canada | IEC 61000-3-3:2008-Ed.2.0 | |
| Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-2:2008-Ed.2.0 | |
| Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-3:2010-Ed.3.2 | |
| Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-4:2012-Ed.3.0 | |
| Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-5:2005-Ed.2.0 | |
| Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-6:2008-Ed.3.0 | |
| Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-8:2009-Ed.2.0 | |
| Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - | 2022 | Federal | Health Canada | IEC 61000-4-11:2004-Ed.2.0 | |
| Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 80601-2-30:2009-Ed.1.0 | |
| Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement | 2022 | Federal | Health Canada | IEC CISPR 11:2010-Ed.5.1 | |
| Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. | 2022 | Federal | Health Canada | ISO 14708-1:2014-Ed.2.0 | |
| Standard Practice for Performance Testing of Shipping Containers and Systems | 2022 | Federal | Health Canada | ASTM D4169-16 | |
| Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained | 2022 | Federal | Health Canada | ASTM F1140-13 | |
| Standard test method for detecting seal leaks in porous medical packaging by dye | 2022 | Federal | Health Canada | ASTM F1929-98:2004/(R 2004) | |
| Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization | 2022 | Federal | Health Canada | ASTM F2096-11 | |
| Standard Test Method for Seal Strength of Flexible Barrier Materials | 2022 | Federal | Health Canada | ASTM F188-15 | |
| Medical device software - Software life cycle processes | 2022 | Federal | Health Canada | IEC 62304:2015-Ed.1.1 | |
| Medical devices -Part 1: Application of usability engineering to medical devices | 2022 | Federal | Health Canada | IEC 62366-1:2015-Ed.1.0 | |
| Standard Specification for Rubber Surgical Gloves | 2022 | Federal | Health Canada | ASTM D3577-19 | |
| Standard Specification for Rubber Examination Gloves | 2022 | Federal | Health Canada | ASTM D3578-19 | |
| Standard Specification for Poly(vinyl chloride) Gloves for Medical Application | 2022 | Federal | Health Canada | ASTM D5250-19 | |
| Standard Specification for Nitrile Examination Gloves for Medical Application | 2022 | Federal | Health Canada | ASTM D6319-19 | |
| Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by | 2022 | Federal | Health Canada | ASTM D6978-05 (R2019) | |
| Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology | 2022 | Federal | Health Canada | ISO 374-1:2016-Ed.1.0 | |
| Protective gloves against dangerous chemicals and micro-organisms - Part 2: Determination | 2022 | Federal | Health Canada | ISO 374-2:2019-Ed.1.0 | |
| Protective gloves against dangerous chemicals and micro-organisms - Part 4: Determination | 2022 | Federal | Health Canada | ISO 374-4:2019-Ed.1.0 | |
| Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology | 2022 | Federal | Health Canada | ISO 374-5:2016-Ed.1.0 | |
| Single-Use Sterile Surgical Rubber Gloves - Specification | 2022 | Federal | Health Canada | ISO 10282:2002-Ed.2.0 | |
| Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution | 2022 | Federal | Health Canada | ISO 11193-1:2020-Ed.3.0 | |
| Single-use medical examination gloves Part 2: Specification for gloves made from poly(vinyl chloride) | 2022 | Federal | Health Canada | ISO 11193-2:2006-Ed.1.0 | |
| Quality of dialysis fluid for haemodialysis and related therapies | 2022 | Federal | Health Canada | ISO 11663:2009-Ed.1.0 | |
| Water for haemodialysis and related therapies | 2022 | Federal | Health Canada | ISO 13959:2009-Ed.2.0 | |
| Clinical investigation of medical devices for human subjects - Good clinical practice | 2022 | Federal | Health Canada | ISO 14155:2020-Ed.3.0 | |
| Medical devices - Application of risk management to medical devices | 2022 | Federal | Health Canada | ISO 14971:2019-Ed.3.0 | |
| Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management | 2022 | Federal | Health Canada | ISO 22442-1:2020-Ed.3.0 | |
| Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling | 2022 | Federal | Health Canada | ISO 22442-2:2020-Ed.3.0 | |
| Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy | 2022 | Federal | Health Canada | ISO 22442-3:2007-Ed.1.0 | |
| Water treatment equipment for haemodialysis applications and related therapies | 2022 | Federal | Health Canada | ISO 26722:2009-Ed.1.0 | |
| Tampons - Menstrual | 2022 | Federal | Health Canada | SAI AS 2869:2008-Ed.4.0 | |
| Performance of filtering respirators | 2022 | Federal | Health Canada | CSA Z94.4.1:2021-Ed.1.0 | |
| Blood gas and pH analysis and related measurements; Approved guideline | 2022 | Federal | Health Canada | CLSI C46-A2:2009-Ed.2.0 | |
| User protocol for evaluation of qualitative test performance; Approved guideline | 2022 | Federal | Health Canada | CLSI EP12-A2:2008-Ed.2.0 | |
| Evaluation of Commutability of Processed Samples; Approved guideline | 2022 | Federal | Health Canada | CLSI EP14-A3:2014-Ed.3.0 | |
| Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures | 2022 | Federal | Health Canada | CLSI EP17-A2:2012-Ed.2.0 | |
| Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating | 2022 | Federal | Health Canada | CLSI EP24-A2:2011-Ed.2.0 | |
| Evaluation of stability of in vitro diagnostic reagents; Approved guideline | 2022 | Federal | Health Canada | CLSI EP25-A:2009-Ed.1.0 | |
| Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved | 2022 | Federal | Health Canada | CLSI EP28-A3C:2010-Ed.3.0 | |
| Evaluation of precision of quantitative measurement procedures; Approved guideline | 2022 | Federal | Health Canada | CLSI EP5-A3:2014-Ed.3.0 | |
| Evaluation of Linearity of Quantitative Measurement Procedures | 2022 | Federal | Health Canada | CLSI EP06:2020-Ed.2.0 | |
| Interference Testing in Clinical Chemistry | 2022 | Federal | Health Canada | CLSI EP07:2018-Ed.3.0 | |
| Reference and selected procedures for the quantitative determination of hemoglobin in | 2022 | Federal | Health Canada | CLSI H15-A3:2000-Ed.3.0 | |
| Reference leukocyte (WBC) differential count (proportional) and evaluation of instrumental | 2022 | Federal | Health Canada | CLSI H20-A2:2007-Ed.2.0 | |
| Specifications for immunological testing for infectious diseases; Approved guideline | 2022 | Federal | Health Canada | CLSI I/LA18-A2:2001-Ed.2.0 | |
| Clinical evaluation of immunoassays; Approved guideline | 2022 | Federal | Health Canada | CLSI I/LA21-A2:2008-Ed.2.0 | |
| Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline | 2022 | Federal | Health Canada | CLSI MM01-A3:2012-Ed.3.0 | |
| Quantitative Molecular Methods for Infectious Diseases | 2022 | Federal | Health Canada | CLSI MM06-A2:2010-Ed.2.0 | |
| Diagnostic nucleic acid microarrays; Approved guideline | 2022 | Federal | Health Canada | CLSI MM12-A:2006-Ed.1. | |
| Collection, transport, preparation, and storage of specimens for molecular methods | 2022 | Federal | Health Canada | CLSI MM13-A:2005-Ed.1.0 | |
| Use of external RNA controls in gene expression assays; Approved guideline | 2022 | Federal | Health Canada | CLSI MM16-A:2006-Ed.1.0 | |
| Verification and validation of multiplex nucleic acid assays; Approved guideline | 2022 | Federal | Health Canada | CLSI MM17-A:2008-Ed.1.0 | |
| Point-of-care monitoring of anticoagulation therapy; Approved guideline | 2022 | Federal | Health Canada | CLSI POCT14-A:2004-Ed.1.0 | |
| Safety requirements for electrical equipment for measurement, control, and laboratory use | 2022 | Federal | Health Canada | "IEC 61010-1:2010-Ed.3.0, IEC 61010-2-101:2015-Ed.2.0" | |
| Electrical equipment for measurement, control and laboratory use - EMC requirements Part | 2022 | Federal | Health Canada | IEC 61326-1:2012-Ed.2.0 | |
| In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for | 2022 | Federal | Health Canada | ISO 15197:2013-Ed.2.0 | |
| In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents | 2022 | Federal | Health Canada | ISO 23640:2011-Ed.1.0 | |
| Standard specification for powder bed fusion of plastic materials | 2022 | Federal | Health Canada | ASTM F3091/F3091M-14 (R2021) | |
| Standard guide for assessing the removal of additive manufacturing residues in medical | 2022 | Federal | Health Canada | ASTM F3335-20 | |
| Aseptic processing of health care products - Part 1 : General requirements | 2022 | Federal | Health Canada | ISO 13408-1:2008-Ed.2.0 | |
| Aseptic processing of health care products - Part 2 : Filtration | 2022 | Federal | Health Canada | ISO 13408-2:2003-Ed.1.0 | |
| Aseptic processing of health care products - Part 3 : Lyophilization | 2022 | Federal | Health Canada | ISO 13408-3:2006-Ed.1.0 | |
| Aseptic processing of health care products - Part 4 : Clean-in-place technologies | 2022 | Federal | Health Canada | ISO 13408-4:2005-Ed.1.0 | |
| Aseptic processing of health care products - Part 5 : Sterilization in place | 2022 | Federal | Health Canada | ISO 13408-5:2006-Ed.1.0 | |
| Aseptic processing of health care products - Part 6 : Isolator systems | 2022 | Federal | Health Canada | ISO 13408-6:2005-Ed.1.0 | |
| Aseptic processing of health care products - Part 7 : Alternative processes for medical | 2022 | Federal | Health Canada | ISO 13408-7:2012-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness | 2022 | Federal | Health Canada | ISO 14644-1:1999-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 2: Specifications for testing and | 2022 | Federal | Health Canada | ISO 14644-2:2000-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 3: Test methods | 2022 | Federal | Health Canada | ISO 14644-3:2005-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 4: Design, Construction and Start | 2022 | Federal | Health Canada | ISO 14644-4:2001-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 5: Operations | 2022 | Federal | Health Canada | ISO 14644-5:2004-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 6: Vocabulary | 2022 | Federal | Health Canada | ISO 14644-6:2007-Ed.1.0 | |
| Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air | 2022 | Federal | Health Canada | ISO 14644-7:200 | |
| Standard specification for beta-tricalcium phosphate for surgical implantations | 2022 | Federal | Health Canada | ASTM F1088-04a | |
| Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy surgical | 2022 | Federal | Health Canada | ASTM F1088-04a:2010/(R 2010)ASTM F1091-08 | |
| Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical | 2022 | Federal | Health Canada | ASTM F1108-04 | |
| Standard specification for wrought titanium-6 aluminum-7 niobium alloy for surgical implant | 2022 | Federal | Health Canada | ASTM F1295-05 | |
| Standard specification for wrought nitrogen strengthened 22chromium-13nickel- | 2022 | Federal | Health Canada | ASTM F1314-07 | |
| Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel | 2022 | Federal | Health Canada | ASTM F1350-08 | |
| Standard specification for wrought titanium-6aluminum-4vanadium ELI (Extra Low | 2022 | Federal | Health Canada | ASTM F136-12 | |
| Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar | 2022 | Federal | Health Canada | ASTM F138-08 | |
| Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel | 2022 | Federal | Health Canada | ASTM F139-08 | |
| Standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical | 2022 | Federal | Health Canada | ASTM F1472-08 | |
| Standard specification for wrought cobalt-28 chromium-6 molybdenum alloy for surgical | 2022 | Federal | Health Canada | ASTM F1537-08 | |
| Standard specification for titanium and titanium-6aluminum-4vanadium alloy powders for | 2022 | Federal | Health Canada | ASTM F1580-12 | |
| Standard specification for wrought nitrogen strengthened 21chromium-10nickel�3mangane | 2022 | Federal | Health Canada | ASTM F1586-08 | |
| Standard specification for wrought titanium-13niobium-13zirconium alloy for surgical | 2022 | Federal | Health Canada | ASTM F1713-08 | |
| Standard specification for polyetheretherketone (PEEK) polymers for surgical implant | 2022 | Federal | Health Canada | ASTM F2026-16 | |
| Standard guide for extensively irradiation-crosslinked ultra-high molecular weight | 2022 | Federal | Health Canada | ASTM F2565-06 | |
| Standard specification for ultra-high molecular weight polyethylene powder blended with | 2022 | Federal | Health Canada | ASTM F2695-12 (R2020) | |
| Standard specification for additive manufacturing Titanium-6 Aluminum-4 Vanadium with | |||||
| Standard specification for additive manufacturing Titanium-6 Aluminum-4 Vanadium ELI | 2022 | Federal | Health Canada | ASTM F3001-14 (R2021) | |
| Standard for additive manufacturing - finished part properties - standard specification for | 2022 | Federal | Health Canada | ASTM F3213-17 | |
| Standard specification for unalloyed tantalum for surgical implant applications (UNS R05200, | 2022 | Federal | Health Canada | ASTM F560-08 | |
| Standard specification for wrought 35cobalt-35nickel-20chromium-10molybdenum alloy for | 2022 | Federal | Health Canada | ASTM F562-07 | |
| Standard specification for alpha plus beta titanium alloy forgings for surgical implants | 2022 | Federal | Health Canada | ASTM F620-06 | |
| Standard specification for stainless steel forgings for surgical implants | 2022 | Federal | Health Canada | ASTM F621-08 | |
| Standard specification for ultra-high-molecular weight polyethylene powder and fabricated | 2022 | Federal | Health Canada | ASTM F648-07 | |
| Standard specification for unalloyed titanium for surgical implant applications (UNS R50250, | 2022 | Federal | Health Canada | ASTM F648-07:2007/(e 2007)ASTM F67-06 | |
| Standard specification for wrought cobalt-35 nickel-20 chromium-10 molybdenum alloy | 2022 | Federal | Health Canada | ASTM F688-05 | |
| Standard specification for cobalt-28chromium-6molybdenum alloy castings and casting alloy | 2022 | Federal | Health Canada | ASTM F75-12 | |
| Standard specification for cobalt-28chromium-6molybdenum alloy forgings for surgical | 2022 | Federal | Health Canada | ASTM F799-11 | |
| Standard specification for wrought stainless steel for surgical instruments | 2022 | Federal | Health Canada | ASTM F899-12 | |
| Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy for | 2022 | Federal | Health Canada | ASTM F90-09 | |
| Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy forgings for surgical implants (UNS R30035) | 2022 | Federal | Health Canada | ASTM F961-08 | |
| Plastic collapsible containers for human blood and blood components - Part 1: Conventional | 2022 | Federal | Health Canada | ISO 3826-1:2003-Ed.1.0 | |
| Implants for Surgery - Metallic materials - Part 1: Wrought stainless steel | 2022 | Federal | Health Canada | ISO 5832-1:2007-Ed.4.0 | |
| Implants for surgery - Metallic materials - Part 2: Unalloyed titanium | 2022 | Federal | Health Canada | ISO 5832-2:1999-Ed.3.0 | |
| Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4- | 2022 | Federal | Health Canada | ISO 5832-3:1996-Ed.3.0 | |
| Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting | 2022 | Federal | Health Canada | ISO 5832-4:1996-Ed.2.0 | |
| Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten- | 2022 | Federal | Health Canada | ISO 5832-5:2005-Ed.3.0 | |
| Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium- | 2022 | Federal | Health Canada | ISO 5832-6:1997-Ed.2.0 | |
| Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel | 2022 | Federal | Health Canada | ISO 5832-9:2007-Ed.2.0 | |
| Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7- | 2022 | Federal | Health Canada | ISO 5832-11:1994-Ed.1.0 | |
| Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum | 2022 | Federal | Health Canada | ISO 5832-12:2007-Ed.2.0 | |
| Implants for surgery - Ultra-high molecular weight polyethylene - Part 2: Moulded forms | 2022 | Federal | Health Canada | ISO 5834-2:2011-Ed.4.0 | |
| Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity | 2022 | Federal | Health Canada | ISO 6474-1:2010-Ed.1.0 | |
| Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purity | 2022 | Federal | Health Canada | ISO 6474-2:2012-Ed.1.0 | |
| Surgical instruments - Metallic materials - Part 1: Stainless steel | 2022 | Federal | Health Canada | ISO 7153-1:1991-Ed.2.0 | |
| Surgical and dental hand instruments - Determination of resistance against autoclaving, | 2022 | Federal | Health Canada | ISO 13402:1995-Ed.1.0 | |
| Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant | 2022 | Federal | Health Canada | ISO 13782:1996-Ed.1.0 | |
| Non-active surgical implants - Implant coating - Part 1: General requirements | 2022 | Federal | Health Canada | ISO 17327-1:2018-Ed.1.0 | |
| Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-10:2012-Ed.2.0 | |
| Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components | 2022 | Federal | Health Canada | ISO 7197:2006-Ed.3.0 | |
| Implants for Surgery - Active implantable medical devices -- Part 3: Implantable | 2022 | Federal | Health Canada | ISO 14708-3:2017-Ed.2.0 | |
| Implants for surgery - Active implantable medical devices - Part 7: Particular requirements | 2022 | Federal | Health Canada | ISO 14708-7:2013-Ed.1.0 | |
| Ophthalmic optics – Intraocular lenses | 2022 | Federal | Health Canada | ANSI Z80.7:2002 | |
| Ophthalmic instruments - Fundus cameras | 2022 | Federal | Health Canada | ISO 10940:2009-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary | 2022 | Federal | Health Canada | ISO 11979-1:2006-Ed.2.0 | |
| Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods | 2022 | Federal | Health Canada | ISO 11979-2:2014-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods | 2022 | Federal | Health Canada | ISO 11979-3:2006-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information | 2022 | Federal | Health Canada | ISO 11979-4:2008-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility | 2022 | Federal | Health Canada | ISO 11979-5:2006-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability | 2022 | Federal | Health Canada | ISO 11979-6:2007-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations | 2022 | Federal | Health Canada | ISO 11979-7:2006-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements | 2022 | Federal | Health Canada | ISO 11979-8:2017-Ed.3.0 | |
| Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular | 2022 | Federal | Health Canada | ISO 11979-10:2018-Ed.2.0 | |
| Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical | 2022 | Federal | Health Canada | ISO TR 22979:2017-Ed.2.0 | |
| Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical | 2022 | Federal | Health Canada | ISO 11980:2009-Ed.2.0 | |
| Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments | 2022 | Federal | Health Canada | ISO 15004-1:2020-Ed.2.0 | |
| Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection | 2022 | Federal | Health Canada | ISO 15004-2:2007-Ed.1.0 | |
| Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and recommendations for labelling specifications | 2022 | Federal | Health Canada | ISO 18369-1:2006-Ed.1.0 | |
| Ophthalmic optics – Contact lenses – Part 2: Tolerances | 2022 | Federal | Health Canada | ISO 18369-2:2006-Ed.1.0 | |
| Ophthalmic optics – Contact lenses – Part 3: Measurement methods | 2022 | Federal | Health Canada | ISO 18369-3:2006-Ed.1.0 | |
| Ophthalmic optics – Contact lenses – Part 4: Physicochemical properties of contact lens materials | 2022 | Federal | Health Canada | ISO 18369-4:2006-Ed.1.0 | |
| Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | 2022 | Federal | Health Canada | IEC 80601-2-58:2016-Ed.2.1 | |
| Standard test method for shear testing of calcium phosphate coatings and metallic coatings | 2022 | Federal | Health Canada | ASTM F1044-05 | |
| Standard test method for corrosion of surgical instruments | 2022 | Federal | Health Canada | ASTM F1089-10 | |
| Standard test method for tension testing of calcium phosphate and metal coatings | 2022 | Federal | Health Canada | ASTM F1147-05 | |
| Standard test method for shear and bending fatigue testing of calcium phosphate and | 2022 | Federal | Health Canada | ASTM F1160-14 (R2017)(E2017) | metal coatings |
| Standard specification and test methods for intramedullary fixation devices | 2022 | Federal | Health Canada | ASTM F1264-16 (E2016) | |
| Standard specification for cobalt-28chromium-6molybdenum powder for coating of | 2022 | Federal | Health Canada | ASTM F1377-13 | implantable materials |
| Standard specification for shoulder prostheses | 2022 | Federal | Health Canada | ASTM F1378-18 (E2019) | |
| Standard Specification for calcium phosphate coatings for implantable materials | 2022 | Federal | Health Canada | ASTM F1609-08 | |
| Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | 2022 | Federal | Health Canada | ASTM F1717-18 | |
| Standard Test Method for evaluating the static and fatigue properties of interconnection | 2022 | Federal | Health Canada | ASTM F1798-13 | components |
| Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements | 2022 | Federal | Health Canada | ASTM F1800-12 | |
| Standard practice for corrosion fatigue testing of metallic implant materials | 2022 | Federal | Health Canada | ASTM F1801-20 | |
| Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in | 2022 | Federal | Health Canada | ASTM F1829-17 | total hip arthroplasty |
| Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral | 2022 | Federal | Health Canada | ASTM F1875-98 | |
| Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation | 2022 | Federal | Health Canada | ASTM F2028-14 | |
| Test Methods for Intervertebral Body Fusion Devices | 2022 | Federal | Health Canada | ASTM F2077-18 | |
| Standard specification for knee replacement prosthesis | 2022 | Federal | Health Canada | ASTM F2083-21 | |
| Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion | 2022 | Federal | Health Canada | ASTM F2267-04 | |
| Standard test methods for static and dynamic characterization of spinal artificial discs | 2022 | Federal | Health Canada | ASTM F2346-18
To add the orthopedics-related standards to the wiki page, you can use the following code: ```wiki | |
| Standard Test Method for Impingement of Acetabular Prostheses | 2022 | Federal | Health Canada | ASTM F2582-20 | |
| Standard Specification for Total Ankle Replacement Prosthesis | 2022 | Federal | Health Canada | ASTM F2665-09 | |
| Standard Guide for Presentation of End User Labeling Information for Musculoskeletal | 2022 | Federal | Health Canada | ASTM F2943-14 | |
| Standard test method for cyclic fatigue testing of metal tibial tray components of | 2022 | Federal | Health Canada | ASTM F3140-17 | |
| Standard Specification and Test Methods for Metallic Medical Bone Screws | 2022 | Federal | Health Canada | ASTM F543-17 | |
| Standard test method for pitting or crevice corrosion of metallic surgical implant materials | 2022 | Federal | Health Canada | ASTM F746-04 | |
| Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants | 2022 | Federal | Health Canada | ASTM F86-21 | |
| Standard test method for measuring fretting corrosion of osteosynthesis plates and screws | 2022 | Federal | Health Canada | ASTM F897-19 | |
| Standard practice for permanent marking of orthopaedic implant components | 2022 | Federal | Health Canada | ASTM F983-86 | |
| Implants for surgery - Metallic skeletal pins and wires Part 1: General requirements | 2022 | Federal | Health Canada | ISO 5838-1:2013-Ed.3.0 | |
| Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimension | 2022 | Federal | Health Canada | ISO 5838-2:1991-Ed.1.0 | |
| Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires | 2022 | Federal | Health Canada | ISO 5838-3:1993-Ed.1.0 | |
| Surgical instruments - Metallic materials - Part 1: Stainless steel | 2022 | Federal | Health Canada | ISO 7153-1:1991-Ed.2.0 | |
| Implants for surgery partial and total hip joint prostheses - Part 4: Determination of | 2022 | Federal | Health Canada | ISO 7206-4:2010-Ed.3.0 | |
| Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties | 2022 | Federal | Health Canada | ISO 7206-6:2013-Ed.2.0 | |
| Implants for surgery - Non-destructive testing - Liquid penetrant inspection of metallic | 2022 | Federal | Health Canada | ISO 9583:1993-Ed.1.0 | |
| Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and | 2022 | Federal | Health Canada | ISO 14242-1:2014-Ed.3.0 | |
| Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement | 2022 | Federal | Health Canada | ISO 14242-2:2016-Ed.2.0 | |
| Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement | 2022 | Federal | Health Canada | ISO 14243-1:2009-Ed.2.0 | |
| Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement | 2022 | Federal | Health Canada | ISO 14243-2:2016-Ed.3.0 | |
| Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and | 2022 | Federal | Health Canada | ISO 14243-3:2014-Ed.2.0 | |
| Non-active surgical implants - General requirements | 2022 | Federal | Health Canada | ISO 14630:2012-Ed.4.0 | |
| Acoustic output measurement standard for diagnostic ultrasound equipment | 2022 | Federal | Health Canada | AIUM/NEMA UD 2:2004/(R 2009) | |
| Standard for real-time display of thermal and mechanical acoustic output indices on | 2022 | Federal | Health Canada | AIUM/NEMA UD 3:2004 | |
| Medical electrical equipment - Part 1-3: General requirements for basic safety and essential | 2022 | Federal | Health Canada | IEC 60601-1-3:2021-Ed.2.2 | |
| Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-28: 2017-Ed.3.0 | |
| Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-37:2015-Ed.2.1 | |
| Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-43:2019-Ed.2.2 | |
| Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-44:2016-Ed.3.2 | |
| Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-45:2015-Ed.3.1 | |
| Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-54:2018-Ed.1.2 | |
| Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and | 2022 | Federal | Health Canada | IEC 60601-2-63:2021-Ed.1.2 | |
| Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | 2022 | Federal | Health Canada | ASTM F1980-07 | |
| Sterilization of health care products - Moist heat Part 1: Requirements for the development, | 2022 | Federal | Health Canada | CAN/CSA Z17665-1-09:2009-Ed.1.0 | |
| Sterilization of health care products - Ethylene oxide - Requirements for the development, | 2022 | Federal | Health Canada | ISO 11135:2014-Ed.2.0 | |
| Sterilization of health care products - Radiation - Part 1: Requirement for development, validation and routine control of a sterilization process for medical devices | 2022 | Federal | Health Canada | ISO 11137-1:2006-Ed.1.0 | |
| Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | 2022 | Federal | Health Canada | ISO 11137-2:2013-Ed.3.0 | |
| Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects | 2022 | Federal | Health Canada | ISO 11137-3:2017-Ed.2.0 | |
| Sterilization of health care products - Biological indicators - Part 1: General | 2022 | Federal | Health Canada | ISO 11138-1:2017-Ed.3.0 | |
| Sterilization of health care products - Biological indicators - Part 2: Biological indicators for | 2022 | Federal | Health Canada | ISO 11138-2:2017-Ed.3.0 | |
| Sterilization of health care products - Biological indicators - Part 3: Biological indicators for | 2022 | Federal | Health Canada | ISO 11138-3:2017-Ed.3.0 | |
| Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | 2022 | Federal | Health Canada | ISO 11607-1:2019-Ed.2.0 | |
| Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes | 2022 | Federal | Health Canada | ISO 11607-2:2019-Ed.2.0 | |
| Sterilization of medical devices - Microbiological methods - Part 1: Determination of population of microorganisms on products | 2022 | Federal | Health Canada | ISO 11737-1:2018-Ed.3.0 | |
| Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices | 2022 | Federal | Health Canada | ISO 14160:2020-Ed.3.0 | |
| Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | 2022 | Federal | Health Canada | ISO 14937:2009-Ed.2.0 | |
| 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 | 2022 | Federal | Health Canada | ISO 17664-1:2021-Ed.1.0 | |
| 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 | 2022 | Federal | Health Canada | ISO 17664-2:2021-Ed.1.0 | |
| Sterilization of health care products - Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | 2022 | Federal | Health Canada | ISO 17665-1:2006-Ed.1.0 | |
| US Legislation & Regulations | 2023 | Federal | FDA USA | FDA Device Classification Panels | |
| Health Insurance Portability and Accountability Act | 2023 | Federal | FDA USA | CDC - HIPAA | |