Draft: List of recognized standards for medical devices

Consult the following guidance document on using this list and recognized standards, including version recognition for standards listed without years and editions:

Guidance on using standards to support compliance with the Medical Devices Regulations

Changes to the list

Standards added

ASTM F2052: Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment
ASTM F2100: Standard specification for performance of materials used in medical face masks
ASTM F2119: Standard test method for evaluation of MR image artifacts from passive implants
ASTM F2182: Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging
ASTM F2213: Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment
ASTM F2503: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
ASTM F3690: Standard test method for evaluating suture anchor insertion and pull displacement resistance
CLSI EP35: Assessment of equivalence or suitability of specimens types for medical laboratory measurement procedures
EN 14683: Medical face masks – Requirements and test methods
IEC 60601-1-12: 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
IEC 60601-2-17: Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
IEC 60601-2-83: Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
IEC 80601-2-26: Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 80601-2-49: Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 80601-2-77: Medical electrical equipment – Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
ISO 9394: Ophthalmic optics – Contact lenses and contact lens care products – Determination of biocompatibility by ocular study with rabbit eyes
ISO 9693: Dentistry – Compatibility testing for metal-ceramic and ceramic-ceramic systems
ISO TS/10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 11981: Ophthalmic optics – Contact lenses and contact lens care products – Determination of physical compatibility of contact lens care products with contact lenses
ISO 11986: Ophthalmic optics – Contact lenses and contact lens care products – Determination of preservative uptake and release
ISO 13212: Ophthalmic optics – Contact lens care products – Guidelines for determination of shelf-life
ISO 14729: Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14730: Ophthalmic optics – Contact lens care products – Antimicrobial preservative efficacy testing and guidance on determining discard date
ISO 17665: Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
ISO 18562-2: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances
ISO 18562-4: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate
ISO 21535: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants
ISO 21536: Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants
ISO 80601-2-69: Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
ISO 80601-2-85: Medical electrical equipment – Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
ISO 81060-2: Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type

Standards updated

As we have generally removed the years and editions from recognized standards on the list, standards updated for other reasons are included here.

CLSI EP25: Evaluation of stability of in vitro diagnostic reagents – Approved guideline
- Except Section 7.1.2.3 (Ed. 2, 2023)
IEC 60601-2-24: Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- Refer to 'AAMI TIR101 - Fluid Delivery Performance Testing for Infusion Pumps' for recommended delivery performance testing framework and corresponding information to be included in the pump labeling which align with expectations outlined in the 2018 Health Canada Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps
ISO 10993-1: Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
- Devices subject to Clause 6.5.11.2 (Ed. 6, 2025) may require additional testing beyond that which is specified in that clause

Standards removed

ASTM F2083: Standard specification for knee replacement prosthesis
CLSI MM12: Diagnostic nucleic acid microarrays – Approved guideline
CLSI MM16: Use of external RNA controls in gene expression assays – Approved guideline
IEC 60601-2-26: Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 60601-2-49: Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 8359: Oxygen concentrators for medical use – Safety requirements
ISO 9693-1: Dentistry – Compatibility testing – Part 1: Metal-ceramic systems
ISO 14644-6: Cleanrooms and associated controlled environments – Part 6: Vocabulary
ISO 17665-1: Sterilization of health care products – Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

List of recognized standards

Anesthetic and respiratory

ASME PVHO-1: Safety standard for pressure vessels for human occupancy
ISO 5356-1: Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets
ISO 5356-2: Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded weight-bearing connectors
ISO 5360: Anaesthetic vaporizers – Agent specific filling system
ISO 7199: Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process
ISO 18562-2: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter
ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances
ISO 18562-4: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate
ISO 80601-2-12: Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13: Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 80601-2-55: Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-61: Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- For section 201.12 (Ed. 2, 2017):
  - accuracy requirements may be tightened compared to the maximum allowable tolerances for accuracy
  - more clinical evidence from a larger group of individuals may be required to ensure that validation is available across:
    - a diverse group of individuals with varying skin pigmentation and
    - the full range of oxygenation levels
ISO 80601-2-69: Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
ISO 80601-2-72: Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
ISO 80601-2-85: Medical electrical equipment – Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

Biocompatibility

ASTM F981: Standard practice for assessment of muscle and bone tissue responses to long-term implantable materials used in medical devices
ISO 10993-1: Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
- Devices subject to Clause 6.5.11.2 (Ed. 6, 2025) may require additional testing beyond that which is specified in that clause
ISO 10993-2: Biological evaluation of medical devices – Part 2: Animal welfare requirements
ISO 10993-3: Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- For Clause 6.2 (Ed. 3, 2014):
  - in most cases, testing on 1 rodent and 1 non-rodent species is required
- For Clause 7.2 (Ed. 3, 2014):
  - results from a test material would only be considered if the test sample has undergone identical processing steps to the final finished product
ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-6: Biological evaluation of medical devices – Part 6: Tests for local effects after implantation
ISO 10993-7: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
ISO 10993-9: Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- The following sections (Ed. 4, 2021) are not recognized:
  - Clause 4, General principles – Step-wise approach
  - Annex C, Non-animal methods for skin sensitization
ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
ISO 10993-13: Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices
- For Clause 4.1.1 and Clause 5.3.4.2, Figure 1 (Ed. 2, 2010):
  - using the accelerated degradation test as a screening test or a substitute for the real-time degradation test may not be appropriate for all materials and all degradation testing conditions
    - for example, bioabsorbable polymers
ISO 10993-14: Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15: Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-16: Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17: Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-23: Biological evaluation of medical devices – Part 23: Tests for irritation
- The following sections (Ed. 1, 2021) are not recognized:
  - Clause 4, General principles – Step-wise approach
  - Clause 6, In vitro irritation tests
  - Annex B, Test method checklist for in vitro irritation testing using reconstructed human epidermis models
  - Annex C, Example of method documentation sheet for reconstructed human epidermis models

Cardiovascular

ISO 5840-1: Cardiovascular implants – Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements
- For heart valve substitutes:
  - durability testing may be required beyond 200 million cycles, especially where long-term clinical durability evidence is not available for the indicated patient population
ISO 5840-2: Cardiovascular implants – Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes
ISO 5840-3: Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 5841-3: Implants for surgery – Cardiac pacemakers – Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 7198: Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches
ISO 10555-1: Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements
ISO 10555-3: Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters
ISO 10555-4: Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters
ISO 10555-5: Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters
ISO 11318: Cardiac defibrillators – Connector assembly DF-1 for implantable defibrillators – Dimensions and test requirements
ISO 12417-1: Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products – Part 1: General requirements
ISO 14117: Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 14708-2: Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
ISO 14708-5: Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
ISO 14708-6: Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents
ISO 27186: Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
ISO 81060-2: Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type

Contraception

ISO 4074: Natural latex rubber condoms – Requirements and test methods

Dental

ISO 3107: Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements
ISO 4049: Dentistry – Polymer-based restorative materials
ISO 6872: Dentistry – Ceramic materials
ISO 6874: Dentistry – Polymer-based pit and fissure sealants
ISO 6876: Dentistry – Endodontic sealing materials
ISO 6877: Dentistry – Endodontic obturating materials
ISO 7405: Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
ISO 9693: Dentistry – Compatibility testing for metal-ceramic and ceramic-ceramic systems
ISO 9917-1: Dentistry – Water-based cements – Part 1: Acid-base cements
ISO 9917-2: Dentistry – Water-based cements – Part 2: Resin-modified cements
ISO 10271: Dental metallic materials – Corrosion test methods for metallic materials
ISO/TS 11405: Dental materials – Testing of adhesion to tooth structure
ISO 13116: Dentistry – Test method for determining radio-opacity of materials
ISO 14801: Dentistry – Implants – Dynamic loading test for endosseous dental implants
ISO 22674: Dentistry – Metallic materials for fixed and removable restorations and appliances
ISO 22794: Dentistry – Implantable materials for bone filling and augmentation in oral and maxillofacial surgery – Contents of a technical file
ISO 22803: Dentistry – Membrane materials for guided tissue regeneration in oral and maxillofacial surgery – Contents of a technical file
ISO 24234: Dentistry – Dental amalgam
ISO 29022: Dentistry – Adhesion – Notched-edge shear bond strength test

Electromedical

CAN/CSA C22.2 NO 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60529: Degrees of protection provided by enclosures (IP code)
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-8: 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
IEC 60601-1-10: 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
IEC 60601-1-11: 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
IEC 60601-1-12: 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
IEC 60601-2-1: 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
IEC 60601-2-2: 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
IEC 60601-2-4: Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
IEC 60601-2-5: Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 60601-2-16: Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-17: Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
IEC 60601-2-18: Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 60601-2-22: Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-23: Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
IEC 60601-2-24: Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- Refer to 'AAMI TIR101 - Fluid Delivery Performance Testing for Infusion Pumps' for recommended delivery performance testing framework and corresponding information to be included in the pump labeling which align with expectations outlined in the 2018 Health Canada Notice: Changes to Evidence Requirements for Class II and Class III Infusion Pumps
IEC 60601-2-25: Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-2-27: Medical Electrical Equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-31: Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
IEC 60601-2-33: Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-34: Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
IEC 60601-2-36: Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
IEC 60601-2-47: Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
IEC 60601-2-50: Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
IEC 60601-2-57: Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60601-2-62: Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
IEC 60601-2-83: Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
IEC 60825-1: Safety of laser products – Part 1: Equipment classification and requirements
IEC 80601-2-26: Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 80601-2-30: Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 80601-2-49: Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 80601-2-77: Medical electrical equipment – Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
IEC CISPR 11: Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement
ISO 14708-1: Implants for surgery – Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer.

General

ASTM D3577: Standard specification for rubber surgical gloves
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ASTM D3578: Standard specification for rubber examination gloves
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ASTM D4169: Standard practice for performance testing of shipping containers and systems
ASTM D5250: Standard specification for poly(vinyl chloride) gloves for medical application
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ASTM D6319: Standard specification for nitrile examination gloves for medical application
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ASTM D6978: Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs
ASTM F88: Standard test method for seal strength of flexible barrier materials
ASTM F1140: Standard test methods for internal pressurization failure resistance of unrestrained packages
ASTM F1929: Standard test method for detecting seal leaks in porous medical packaging by dye penetration
ASTM F2052: Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment
ASTM F2096: Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test)
ASTM F2100: Standard specification for performance of materials used in medical face masks
ASTM F2119: Standard test method for evaluation of MR image artifacts from passive implants
ASTM F2182: Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging
ASTM F2213: Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment
ASTM F2503: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
CSA Z94.4.1: Performance of filtering respirators
CSA Z23500-2: Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies
CSA Z23500-3: Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies
CSA Z23500-5: Preparation and quality management of fluids for haemodialysis and related therapies – Part 5: Quality of dialysis fluid for haemodialysis and related therapies
EN 14683: Medical face masks – Requirements and test methods
IEC 62304: Medical device software – Software life cycle processes
IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices
ISO 374-1: Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks
ISO 374-2: Protective gloves against dangerous chemicals and micro-organisms – Part 2: Determination of resistance to penetration
ISO 374-4: Protective gloves against dangerous chemicals and micro-organisms – Part 4: Determination of resistance to degradation by chemicals
ISO 374-5: Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks
ISO 8637-1: Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrator
ISO 10282: Single-use sterile surgical rubber gloves – Specification
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ISO TS/10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO 11193-1: Single-use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ISO 11193-2: Single-use medical examination gloves – Part 2: Specification for gloves made from poly(vinyl chloride)
- Text on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove is not recognized
ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971: Medical devices – Application of risk management to medical devices
ISO 22442-1: Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
ISO 22442-2: Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
ISO 22442-3: Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
SA AS 2869: Tampons – Menstrual

In vitro diagnostic

CLSI C46: Blood gas and pH analysis and related measurements – Approved guideline
CLSI EP05: Evaluation of precision of quantitative measurement procedures – Approved guideline
CLSI EP06: Evaluation of precision of quantitative measurement procedures
CLSI EP07: Interference testing in clinical chemistry
CLSI EP12: Evaluation of qualitative, binary output examination performance
CLSI EP14: Evaluation of commutability of processed samples
CLSI EP17: Evaluation of detection capability for clinical laboratory measurement procedures – Approved guideline
CLSI EP24: Assessment of the diagnostic accuracy of laboratory tests using receiver operating characteristic curves – Approved guideline
CLSI EP25: Evaluation of stability of in vitro medical laboratory test reagents
- Except Section 7.1.2.3 (Ed. 2, 2023)
CLSI EP28: Defining, establishing and verifying reference intervals in the clinical laboratory – Approved guideline
CLSI EP35: Assessment of equivalence or suitability of specimens types for medical laboratory measurement procedures
CLSI H15: Reference and selected procedures for the quantitative determination of hemoglobin in blood – Approved standard
CLSI H20: Reference leukocyte (WBC) differential count (proportional) and evaluation of instrumental methods – Approved standard
CLSI I/LA18: Specifications for immunological testing for infectious diseases – Approved guideline
CLSI I/LA21: Clinical evaluation of immunoassays – Approved guideline
CLSI MM01: Molecular testing for heritable genetics and specimen identification
CLSI MM06: Quantitative molecular methods for infectious diseases– Approved guideline
CLSI MM13: Collection, transport, preparation and storage of specimens for molecular methods
- Except Section 6.1.1
CLSI MM17: Validation and verification of multiplex nucleic acid assays
CLSI POCT14: Point-of-care coagulation testing and anticoagulation monitoring
IEC 61010-1: Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1: General requirements
IEC 61010-2-101: Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-1: Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements
IEC 61326-2-6: Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
ISO 15197:In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 23640:In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents

Manufacturing

ASTM F3091/F3091M: Standard specification for powder bed fusion of plastic materials
ASTM F3335: Standard guide for assessing the removal of additive manufacturing residues in medical devices fabricated by powder bed fusion
ISO 13408-1: Aseptic processing of health care products – Part 1: General requirements
ISO 13408-2: Aseptic processing of health care products – Part 2: Sterilizing filtration
ISO 13408-3: Aseptic processing of health care products – Part 3: Lyophilization
ISO 13408-4: Aseptic processing of health care products – Part 4: Clean-in-place technologies
ISO 13408-5: Aseptic processing of health care products – Part 5: Sterilization in place
ISO 13408-6: Aseptic processing of health care products – Part 6: Isolator systems
ISO 13408-7: Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products
ISO 14644-1: Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration
ISO 14644-2: Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-3: Cleanrooms and associated controlled environments – Part 3: Test methods
ISO 14644-4: Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up
ISO 14644-5: Cleanrooms and associated controlled environments – Part 5: Operations
ISO 14644-7: Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments)
ISO 14644-8: Cleanrooms and associated controlled environments – Part 8: Assessment of air cleanliness by chemical concentration (ACC)
ISO 14644-9: Cleanrooms and associated controlled environments – Part 9: Assessment of surface cleanliness by particle concentration
ISO 14644-10: Cleanrooms and associated controlled environments – Part 10: Assessment of surface cleanliness by chemical concentration
ISO 14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
ISO 14698-2: Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data

Materials

ASTM F67: Standard specification for unalloyed titanium for surgical implant applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
ASTM F75: Standard specification for cobalt-28chromium-6molybdenum alloy castings and casting alloy for surgical implants (UNS R30075)
ASTM F90: Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy for surgical implant applications (UNS R30605)
ASTM F136: Standard specification for wrought titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy for surgical implant applications (UNS R56401)
ASTM F138: Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire for surgical implants (UNS S31673)
ASTM F139: Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip for surgical implants (UNS S31673)
ASTM F560: Standard specification for unalloyed tantalum for surgical implant applications (UNS R05200, UNS R05400)
ASTM F562: Standard specification for wrought 35cobalt-35nickel-20chromium-10molybdenum alloy for surgical implant applications (UNS R30035)
ASTM F620: Standard specification for titanium alloy forgings for surgical implants in the alpha plus beta condition
ASTM F621: Standard specification for stainless steel forgings for surgical implants
ASTM F648: Standard specification for ultra-high-molecular weight polyethylene powder and fabricated form for surgical implants
ASTM F688: Standard specification for wrought cobalt-35 nickel-20 chromium-10 molybdenum alloy plate, sheet and foil for surgical implants (UNS R30035)
ASTM F799: Standard specification for cobalt-28chromium-6molybdenum alloy forgings for surgical implants (UNS R31537, R31538, R31539)
ASTM F899: Standard specification for wrought stainless steel for surgical instruments
ASTM F961: Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy forgings for surgical implants (UNS R30035)
ASTM F1088: Standard specification for medical-grade beta-tricalcium phosphate raw material for implantable medical devices
ASTM F1091: Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy surgical fixation wire (UNS R30605)
ASTM F1108: Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical implants (UNS R56406)
ASTM F1295: Standard specification for wrought titanium-6 aluminum-7 niobium alloy for surgical implant applications (UNS R56700)
ASTM F1314: Standard specification for wrought nitrogen strengthened 22chromium-13nickel-5manganese-2.5molybdenum stainless steel alloy bar and wire for surgical implants (UNS S20910)
ASTM F1350: Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel surgical fixation wire (UNS S31673)
ASTM F1472: Standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications (UNS R56400)
ASTM F1537: Standard specification for wrought cobalt-28 chromium-6 molybdenum alloy for surgical implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM F1580: Standard specification for titanium and titanium-6aluminum-4vanadium alloy powders for coatings of surgical implants
ASTM F1586: Standard specification for wrought nitrogen strengthened 21chromium-10nickel-3manganese-2.5molybdenum stainless steel bar for surgical implants (UNS S31675)
ASTM F1713: Standard specification for wrought titanium-13niobium-13zirconium alloy for surgical implant applications (UNS R58130)
ASTM F2026: Standard specification for polyetheretherketone (PEEK) polymers for surgical implant applications
ASTM F2565: Standard guide for extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
ASTM F2695: Standard specification for ultra-high molecular weight polyethylene powder blended with alpha-tocopherol (vitamin E) and fabricated forms for surgical implant applications
ASTM F2924: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium with powder bed fusion
ASTM F3001: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (extra low interstitial) with powder bed fusion
ASTM F3213: Standard for additive manufacturing - Finished part properties - Standard specification for cobalt-28 chromium-6 molybdenum via powder bed fusion
ISO 3826-1: Plastic collapsible containers for human blood and blood components – Part 1: Conventional containers
ISO 5832-1: Implants for surgery – Metallic materials – Part 1: Wrought stainless steel
ISO 5832-2: Implants for surgery – Metallic materials – Part 2: Unalloyed titanium
ISO 5832-3: Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-4: Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy
ISO 5832-5: Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
ISO 5832-6: Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 5832-9: Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless steel
ISO 5832-11: Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 7-niobium alloy
ISO 5832-12: Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum alloy
ISO 5834-2: Implants for surgery – Ultra-high molecular weight polyethylene – Part 2: Moulded forms
ISO 6474-1: Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina
ISO 6474-2: Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement
ISO 7153-1: Surgical instruments – Materials – Part 1: Metals
ISO 13402: Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 13782: Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant applications
ISO 17327-1: Non-active surgical implants – Implant coating – Part 1: General requirements

Neurology

IEC 60601-2-10: Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
ISO 7197: Neurosurgical Implants – Sterile, single-use hydrocephalus shunts and components
ISO 14708-3: Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
ISO 14708-7: Implants for surgery – Active implantable medical devices – Part 7: Particular requirements for cochlear implant systems

Ophthalmology

ANSI Z80.7: Ophthalmic optics – Intraocular lenses
- Refer to ISO 11979-8 for allowable endotoxin levels
IEC 80601-2-58: 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
ISO 9394: Ophthalmic optics – Contact lenses and contact lens care products – Determination of biocompatibility by ocular study with rabbit eyes
ISO 10940: Ophthalmic instruments – Fundus cameras
ISO 11979-1: Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary
ISO 11979-2: Ophthalmic implants – Intraocular lenses – Part 2: Optical properties and test methods
ISO 11979-3: Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test methods
ISO 11979-4: Ophthalmic implants – Intraocular lenses – Part 4: Labelling and information
ISO 11979-5: Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility
ISO 11979-6: Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability
ISO 11979-7: Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
- The term "approved" IOL used in this standard should be interpreted as "Health Canada licensed" IOL
- Annex C Part C.1 may only be accepted if the parent IOL reference has full clinical investigation as per Annex A
ISO 11979-8: Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements
ISO 11979-10: Ophthalmic implants – Intraocular lenses – Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
ISO 11980: Ophthalmic optics – Contact lenses and contact lens care products – Requirements and guidance for clinical investigations
ISO 11981: Ophthalmic optics – Contact lenses and contact lens care products – Determination of physical compatibility of contact lens care products with contact lenses
ISO 11986: Ophthalmic optics – Contact lenses and contact lens care products – Determination of preservative uptake and release
ISO 13212: Ophthalmic optics – Contact lens care products – Guidelines for determination of shelf-life
ISO 14729: Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14730: Ophthalmic optics – Contact lens care products – Antimicrobial preservative efficacy testing and guidance on determining discard date
ISO 15004-1: Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-2: Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection
ISO 18369-1: Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 18369-2: Ophthalmic optics – Contact lenses – Part 2: Tolerances
ISO 18369-3: Ophthalmic optics – Contact lenses – Part 3: Measurement methods
ISO 18369-4: Ophthalmic optics – Contact lenses – Part 4: Physicochemical properties of contact lens materials
ISO/TR 22979: Ophthalmic implants – Intraocular lenses – Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

Orthopedics

ASTM F86: Standard practice for surface preparation and marking of metallic surgical implants
ASTM F543: Standard specification and test methods for metallic medical bone screws
ASTM F746: Standard test method for pitting or crevice corrosion of metallic surgical implant materials
ASTM F897: Standard test method for measuring fretting corrosion of osteosynthesis plates and screws
ASTM F983: Standard practice for permanent marking of orthopaedic implant components
ASTM F1044: Standard test method for shear testing of calcium phosphate coatings and metallic coatings
ASTM F1089: Standard test method for corrosion of surgical instruments
ASTM F1147: Standard test method for tension testing of calcium phosphate and metal coatings
ASTM F1160: Standard test method for shear and bending fatigue testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coatings
ASTM F1264: Standard specification and test methods for intramedullary fixation devices
ASTM F1377: Standard specification for cobalt-28chromium-6molybdenum powder for medical devices (UNS R30075, UNS R31537, and UNS R31538)
ASTM F1378: Standard specification for shoulder prostheses
ASTM F1609: Standard specification for calcium phosphate coatings for implantable materials
ASTM F1717: Standard test methods for spinal implant constructs in a vertebrectomy model
ASTM F1798: Standard test method for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants
ASTM F1800: Standard practice for cyclic fatigue testing of metal tibial tray components of total knee joint replacements
ASTM F1801: Standard practice for corrosion fatigue testing of metallic implant materials
ASTM F1829: Standard test method for static evaluation of anatomic glenoid locking mechanism in shear
ASTM F1875: Standard practice for fretting corrosion testing of modular implant interfaces: Hip femoral head-bore and cone taper interface
ASTM F2028: Standard test methods for dynamic evaluation of glenoid loosening
ASTM F2077: Standard test methods for intervertebral body fusion devices
ASTM F2267: Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression
ASTM F2346: Standard test methods for static and dynamic characterization of spinal artificial discs
ASTM F2582: Standard test method for impingement of acetabular prostheses
ASTM F2665: Standard specification for total ankle replacement prosthesis
ASTM F2943: Standard guide for presentation of end user labeling information for musculoskeletal implants
ASTM F3140: Standard test method for cyclic fatigue testing of metal tibial tray components of unicondylar knee joint replacements
ASTM F3690: Standard test method for evaluating suture anchor insertion and pull displacement resistance
ISO 5838-1: Implants for surgery – Metallic skeletal pins and wires Part 1: General requirements
ISO 5838-2: Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions
ISO 5838-3: Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires
ISO 7153-1: Surgical instruments – Materials – Part 1: Metals
ISO 7206-4: Implants for surgery partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components
ISO 7206-6: Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ISO 9583: Implants for surgery – Non-destructive testing – Liquid penetrant inspection of metallic surgical implants
ISO 14242-1: Implants for surgery – Wear of total hip-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242-2: Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement
ISO 14243-1: Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
ISO 14243-2: Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement
ISO 14243-3: Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
ISO 14630: Non-active surgical implants – General requirements
ISO 21535: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants
ISO 21536: Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

Radiology

IEC 60601-1-3: Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-28: Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-37: Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-43: Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
IEC 60601-2-44: Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-45: Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
IEC 60601-2-54: Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-63: Medical electrical equipment – Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Sterilization

ASTM F1980: Standard guide for accelerated aging of sterile barrier systems for medical devices
CAN/CSA Z17665-1-09: Sterilization of health care products – Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11135: Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1: Sterilization of health care products – Radiation – Part 1: Requirement for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2: Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
ISO 11137-3: Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects
ISO 11138-1: Sterilization of health care products – Biological indicators – Part 1: General
ISO 11138-2: Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-3: Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-1: Sterilization of medical devices – Microbiological methods – Part 1: Determination of population of microorganisms on products
ISO 11737-3: Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
ISO 14160: 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
ISO 14937: 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
ISO 17664-1: 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
ISO 17664-2: 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
ISO 17665: Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices

Contact Information

Email: standards.committee@hc-sc.gc.ca

Page details

2026-07-27

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