List of Recognized Standards for Medical Devices

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Organization: Health Canada
Date published: 2019/02/26
- Date adopted: 2002/04/11
- Revised date: 2019/02/25
- Effective date: 2019/02/25
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© Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2019
Publication date: February 2019
This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged.
- Cat.: H164-270/2019E-PDF
- ISBN: 978-0-660-29427-8
- Pub.: 180744
Table of Contents
Changes to the List of Recognized Standards
Standards Added
- ISO 5840-1:2015
- Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- ISO 5840-2:2015
- Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - Surgically implanted heart valve substitutes
- ISO 14708-6:2010
- Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
- ISO 14708-7:2013
- Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
- ASTM D4169-16
- Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1140-13
- Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F2096-11
- Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F88-15
- Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1829-17
- Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
- ASTM F1875-98 (R2014)
- Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- ASTM F2582-14
- Standard Test Method for Impingement of Acetabular Prostheses
- ASTM F2665-09 (R2014)
- Standard Specification for Total Ankle Replacement Prosthesis
- ISO 14160:2011
- 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
- IEC 80601-2-58:2016- Ed.2.1
- 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
Standards Updated
- ISO 7198:2016
- Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
- ISO 14708-1:2014
- Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer.
- ISO 14708-3:2017
- Active implantable medical devices -- Part 3: Implantable neurostimulators
- IEC 62304:2015
- Medical device software - Software life cycle processes
- ISO 22442-1:2015 Ed.2
- Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- ISO 22442-2:2015 Ed.2
- Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- ISO 11979-2:2014
- Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
- IEC 60601-1-3:2013
- Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-37:2015
- Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 60601-2-44:2016
- Medical electrical equipment - Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
- IEC 60601-2-54:2015
- Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- ISO 11135:2014
- Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013
- Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
Standards Removed
- ISO 5840:2005
- Cardiovascular implants - Cardiac valve prostheses
- CAN/CSA C22.2 NO 60601-1-2-08:2008
- Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- CAN/CSA C22.2 NO 60601-1-08:2008
- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- CAN/CSA Z900.1-12 :2012
- Cells tissues, and organs for transplantation: General requirements
- CAN/CSA-ISO 14971-07:2007
- Medical devices – Application of risk management to medical devices
- IEC 61010-1:2001-Ed.2.0
- Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
- IEC 61010-1/Cor.1:2002
- IEC 61010-1/Cor.2:2003
- IEC 61010-2-101:2002-Ed.1.0
- Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- CAN/CSA Z11135-1-09:2009
- Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
List of Recognized Standards
Anaesthetic and Respiratory
- ASME PVHO-1:2007
- Safety standard for pressure vessels for human occupancy
- ISO 5356-1:2015-Ed.4.0
- Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
- ISO 5356-2:2012-Ed.3.0
- Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw threaded weight bearing connectors
- ISO 5360:2012-Ed.3.0
- Anaesthetic Vaporizers - Agent Specific Filling System
- ISO 7199:2009
- Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
- ISO 8359:1996
- Oxygen Concentrators for medical use - Safety requirements
- ISO 8359:1996/Amd.1:2012
- ISO 80601-2-12:2011-Ed.1.0
- Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ISO 80601-2-12:2011-Ed.1.0/Cor.1:2011
- ISO 80601-2-13:2011-Ed.1.0
- Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
- ISO 80601-2-13:2011-Ed.1.0/Amd.1:2015
- ISO 80601-2-55:2011-Ed.1.0
- Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-61:2011-Ed.1.0
- Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 80601-2-72:2015-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
Biocompatibility
- ASTM F981-04
- Standard practice for assessment of compatibility of biomaterials for surgical implants with respect to effect of materials on muscle and bone
- ISO 10993-1:2009
- Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-1:2009/Cor.1:2010
- ISO 10993-2:2006
- Biological evaluation of medical devices – Part 2: Animal welfare requirements
- ISO 10993-3:2003
- Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4:2002
- Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
- ISO 10993-4:2002/Amd.1:2006
- ISO 10993-5:2009
- Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6:2007
- Biological evaluation of medical devices – Part 6: Tests for local effects after implantation
- ISO 10993-7:2008
- Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
- ISO 10993-7:2008/Cor.1:2009
- ISO 10993-9:2009
- Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-10:2010
- Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006
- Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- ISO 10993-12:2007
- Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
- ISO 10993-13:2010
- Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices
- ISO 10993-14:2001
- Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics
- ISO 10993-15:2000
- Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
- ISO 10993-16:2010
- Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-17:2002
- Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2005
- Biological evaluation of medical devices – Part 18: Chemical characterization of materials
Cardiovascular
- ISO 5840-1:2015
- Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- ISO 5840-2:2015
- Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - Surgically implanted heart valve substitutes
- ISO 5840-3:2013
- Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
- ISO 5841-3:2013
- Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
- ISO 7198:2016
- Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
- ISO 10555-1:2013
- Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
- ISO 10555-3:2013
- Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
- ISO 10555-4:2013
- Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
- ISO 10555-5:2013
- Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
- ISO 11318:2002
- Cardiac defibrillators – Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
- ISO 14117:2012-Ed.1.0
- Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- ISO 14708-2:2012
- Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
- ISO 14708-5:2010
- Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
- ISO 14708-6:2010
- Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
- ISO 25539-1:2003
- Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
- ISO 25539-1:2003/Amd.1:2005
- ISO 27186:2010
- Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
Contraception
- ISO 4074:2002
- Natural latex rubber condoms – Requirements and test methods
- ISO 4074:2002/Cor.1:2003
- ISO 4074:2002/Cor.2:2008
Dental
- ISO 3107:2011
- Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements
- ISO 4049:2009
- Dentistry – Polymer-based restorative materials
- ISO 6872:2008
- Dentistry – Ceramic materials
- ISO 6874:2005
- Dentistry – Polymer-based pit and fissure sealants
- ISO 6876:2012
- Dental root canal sealing materials
- ISO 6877:2006
- Dentistry – Root-canal obturating points
- ISO 7405:2008
- Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
- ISO 9693:1999
- Metal-ceramic dental restorative systems
- ISO 9693:1999/Amd.1:2005
- ISO 9693-1:2012
- Dentistry – Compatibility testing – Part 1: Metal-ceramic systems
- ISO 9917-1:2007
- Dentistry – Water-based cements – Part 1: Powder/liquid acid-base cements
- ISO 9917-2:2010
- Dentistry - Water-based cements – Part 2: Resin-modified cements
- ISO 10271:2011
- Dental metallic materials – Corrosion test methods for metallic materials
- ISO 14801:2007
- Dentistry — Implants — Dynamic fatigue test for endosseous dental implants
- ISO 22674:2006
- Dentistry – Metallic materials for fixed and removable restorations and appliances
- ISO 22794:2007
- Dentistry – Implantable materials for bone filling and augmentation in oral and maxillofacial surgery – Contents of a technical file
- ISO 22803:2004
- Dentistry – Membrane materials for guided tissue regeneration in oral and maxillofacial surgery – Contents of a technical file
- ISO 24234:2004
- Dentistry – Mercury and alloys for dental amalgam
- ISO/TS 11405:2003
- Dental materials – Testing of adhesion to tooth structure
Electromedical
- CAN/CSA C22.2 NO 60601-1-14:2014
- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60529:2001-Ed.2.1
- Degrees of protection provided by enclosures (IP Code)
- IEC 60529:2001-Ed.2.1/Cor.1:2001
- IEC 60529:2001-Ed.2.1/Cor.2:2007
- IEC 60529:2001-Ed.2.1/Cor.3:2009
- IEC 60601-1:2005-Ed.3.0
- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1:2005-Ed.3.0/Cor.1:2006
- IEC 60601-1:2005-Ed.3.0/Cor.2:2007
- IEC 60601-1:2012-Ed.3.1
- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007-Ed.3.0
- Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 60601-1-2:2014-Ed.4.0
- Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
- IEC 60601-1-6:2013-Ed.3.1
- Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8:2012-Ed.2.1
- 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
- IEC 60601-1-10:2007-Ed 1.0
- 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 60601-1-11:2010 -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
- IEC 60601-2-2:2009-Ed.5.0
- 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 60601-2-4:2010-Ed.3.0
- Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
- IEC 60601-2-5:2009-Ed.3.0
- Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
- IEC 60601-2-10:2012-Ed.2.0
- Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-2-16:2008-Ed.3.0
- Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
- IEC 60601-2-16:2008-Ed.3.0/Cor.1:2008
- IEC 60601-2-18:2009-Ed.3.0
- Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-2-22:2007-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
- IEC 60601-2-23:2011-Ed.3.0
- Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
- IEC 60601-2-24:2012-Ed.2.0
- Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- Additional accuracy testing results for flow rates below 1 ml/h may be required depending on the pump's intended use
- IEC 60601-2-25:2011-Ed.2.0
- Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- IEC 60601-2-26:2012-Ed.3.0
- Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-27:2011-Ed.3.0
- Medical Electrical Equipment – Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment
- IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012
- IEC 60601-2-31:2008-Ed.2.0
- Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- IEC 60601-2-31:2008-Ed.2.0/Amd.1:2011
- IEC 60601-2-33:2010-Ed.3.0
- Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- IEC 60601-2-33:2010-Ed.3.0/Cor.1:2012
- IEC 60601-2-34:2011-Ed.3.0
- Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- IEC 60601-2-47:2012-Ed.2.0
- Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- IEC 60601-2-49:2011-Ed.2.0
- Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- IEC 60601-2-50:2009-Ed.2.0
- Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
- IEC 60601-2-50:2009-Ed.2.0/Cor.1:2010
- IEC 60601-2-57:2011-Ed.1.0
- 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 60825-1:2014-Ed.3.0
- Safety of laser products - Part 1: Equipment classification and requirements
- IEC 61000-3-2:2009-Ed.3.2
- Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
- IEC 61000-3-2:2009-Ed.3.2/Cor.1:2009
- IEC 61000-3-3:2008-Ed.2.0
- Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16A per phase and not subject to conditional connection
- IEC 61000-4-2:2008-Ed.2.0
- Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
- IEC 61000-4-3:2010-Ed.3.2
- Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
- IEC 61000-4-4:2012-Ed.3.0
- Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast transient/burst immunity test
- IEC 61000-4-5:2005-Ed.2.0
- Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test
- IEC 61000-4-5:2005-Ed.2.0/Cor.1:2009
- IEC 61000-4-6:2008-Ed.3.0
- Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to conducted disturbances, induced by radio-frequency fields
- IEC 61000-4-8:2009-Ed.2.0
- Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power frequency magnetic field immunity test
- IEC 61000-4-11:2004-Ed.2.0
- Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips, short interruptions and voltage variations immunity tests
- IEC 80601-2-30:2009-Ed.1.0
- Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 80601-2-30:2009-Ed.1.0/Cor.1:2010
- IEC CISPR 11:2010-Ed.5.1
- Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement
- ISO 14708-1:2014
- Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer.
- ISO 14708-3:2017
- Active implantable medical devices -- Part 3: Implantable neurostimulators
- ISO 14708-7:2013
- Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
General
- ASTM D4169-16
- Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1140-13
- Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F1929-98 (2004)
- Standard test method for detecting seal leaks in porous medical packaging by dye penetration
- ASTM F2096-11
- Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F88-15
- Standard Test Method for Seal Strength of Flexible Barrier Materials
- IEC 62304:2015
- Medical device software - Software life cycle processes
- IEC 62366:2014 - Ed. 1.1
- Medical devices – Application of usability engineering to medical devices
- ISO 10282:2002
- Single-Use Sterile Surgical Rubber Gloves - Specification
- ISO 11193-1:2008
- Single-use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution
- ISO 11193-1:2008/Amd.1:2012
- ISO 11663:2009
- Quality of dialysis fluid for haemodialysis and related therapies
- ISO 13959:2009
- Water for haemodialysis and related therapies
- ISO 14155:2011
- Clinical investigation of medical devices for human subjects – Good clinical practice
- ISO 14155:2011/Cor.1:2011
- ISO 14708-3:2008
- Implants for Surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
- ISO 14971:2007
- Medical devices – Application of risk management to medical devices
- ISO 22442-1:2015 Ed.2
- Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- ISO 22442-2:2015 Ed.2
- Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- ISO 22442-3:2007
- 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
- ISO 26722:2009
- Water treatment equipment for haemodialysis applications and related therapies
- SAI AS 2869:2008
- Tampons – Menstrual
In Vitro Diagnostic
- CLSI C46-A2:2009
- Blood gas and pH analysis and related measurements; Approved guideline
- CLSI EP12-A2:2008
- User protocol for evaluation of qualitative test performance; Approved guideline
- CLSI EP14-A3:2014
- Evaluation of Commutability of Processed Samples; Approved guideline
- CLSI EP17-A2:2012
- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved guideline
- CLSI EP24-A2:2012
- Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition
- CLSI EP25-A:2009
- Evaluation of stability of in vitro diagnostic reagents; Approved guideline
- (Except: Section 7.1.3)
- CLSI EP28-A3C:2010
- Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline
- CLSI EP5-A3:2014
- Evaluation of precision of quantitative measurement procedures; Approved guideline
- CLSI EP6-A:2003
- Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline
- CLSI EP7-A2:2005
- Interference testing in clinical chemistry; Approved guideline
- CLSI H15-A3:2000
- Reference and selected procedures for the quantitative determination of hemoglobin in blood; Approved standard
- CLSI H20-A2:2007
- Reference leukocyte (WBC) differential count (proportional) and evaluation of instrumental methods; Approved standard
- CLSI I/LA18-A2:2001
- Specifications for immunological testing for infectious diseases; Approved guideline
- CLSI I/LA21-A2:2008
- Clinical evaluation of immunoassays; Approved guideline
- CLSI MM01-A3:2012
- Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline
- CLSI MM06-A2:2010
- Quantitative Molecular Methods for Infectious Diseases
- CLSI MM12-A:2006
- Diagnostic nucleic acid microarrays; Approved guideline
- CLSI MM13-A:2006
- Collection, transport, preparation, and storage of specimens for molecular methods; Approved guideline
- (Except: Section 6.1.1)
- CLSI MM16-A:2006
- Use of external RNA controls in gene expression assays; Approved guideline
- CLSI MM17-A:2008
- Verification and validation of multiplex nucleic acid assays; Approved guideline
- CLSI POCT14-A:2004
- Point-of-care monitoring of anticoagulation therapy; Approved guideline
- IEC 61010-1:2010-Ed.3.0
- Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
- IEC 61010-1:2010-Ed.3.0/Cor.1:2011
- IEC 61010-1:2010-Ed.3.0/Cor.2:2013 French Only/Seulement Version Francaise
- IEC 61010-2-101:2015-Ed.2.0
- Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- IEC 61326-1:2012-Ed.2.0
- Electrical equipment for measurement, control and laboratory use – EMC requirements Part 1: General requirements
- IEC 61326-2-6:2012-Ed.2.0
- Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
- ISO 15197:2013
- In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ISO 23640:2011
- In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents
Manufacturing
- ISO 13408-1:2008
- Aseptic processing of health care products - Part 1 : General requirements
- ISO 13408-2:2003
- Aseptic processing of health care products - Part 2 : Filtration
- ISO 13408-3:2006
- Aseptic processing of health care products - Part 3 : Lyophilization
- ISO 13408-4:2005
- Aseptic processing of health care products - Part 4 : Clean-in-place technologies
- ISO 13408-5:2006
- Aseptic processing of health care products - Part 5 : Sterilization in place
- ISO 13408-6:2005
- Aseptic processing of health care products - Part 6 : Isolator systems
- ISO 13408-7:2012
- Aseptic processing of health care products - Part 7 : Alternative processes for medical devices and combination products
- ISO 14644-1:1999
- Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
- ISO 14644-2:2000
- Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
- ISO 14644-3:2005
- Cleanrooms and associated controlled environments - Part 3: Test methods
- ISO 14644-4:2001
- Cleanrooms and associated controlled environments - Part 4: Design, Construction and Start Up
- ISO 14644-5:2004
- Cleanrooms and associated controlled environments - Part 5: Operations
- ISO 14644-6:2007
- Cleanrooms and associated controlled environments - Part 6: Vocabulary
- ISO 14644-7:2004
- Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments)
- ISO 14644-8:2012
- Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
- ISO 14644-9:2012
- Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
- ISO 14644-10:2013
- Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
- ISO 14698-1:2003
- Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
- ISO 14698-2:2003
- Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data
Materials
- ASTM F1088-04a (R2010)
- Standard specification for beta-tricalcium phosphate for surgical implantations
- ASTM F1091-08
- Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy surgical fixation wire (UNS R30605)
- ASTM F1108-04 (R2009)
- Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical implants (UNS R56406)
- ASTM F1295-05
- Standard specification for wrought titanium-6 aluminum-7 niobium alloy for surgical implant applications (UNS R56700)
- ASTM F1314-07
- Standard specification for wrought nitrogen strengthened 22chromium-13nickel-5manganese-2.5molybdenum stainless steel alloy bar and wire for surgical implants (UNS S20910)
- ASTM F1350-08
- Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel surgical fixation wire (UNS S31673)
- ASTM F136-12
- Standard specification for wrought titanium-6aluminum-4vanadium ELI (Extra Low Interstitial) alloy for surgical implant applications (UNS R56401)
- ASTM F138-08
- Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire for surgical implants (UNS S31673)
- ASTM F139-08
- Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel sheet and strip for surgical implants (UNS S31673)
- ASTM F1472-08
- Standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications (UNS R56400)
- ASTM F1537-08
- Standard specification for wrought cobalt-28 chromium-6 molybdenum alloy for surgical implants (UNS R31537, UNS R31538, and UNS R31539)
- ASTM F1580-12
- Standard specification for titanium and titanium-6aluminum-4vanadium alloy powders for coatings of surgical implants
- ASTM F1586-08
- Standard specification for wrought nitrogen strengthened 21chromium-10nickel-3manganese-2.5molybdenum stainless steel bar for surgical implants (UNS S31675)
- ASTM F1713-08
- Standard specification for wrought titanium-13niobium-13zirconium alloy for surgical implant applications (UNS R58130)
- ASTM F2565-06
- Standard guide for extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications
- ASTM F560-08
- Standard specification for unalloyed tantalum for surgical implant applications (UNS R05200, UNS R05400)
- ASTM F562-07
- Standard specification for wrought 35cobalt-35nickel-20chromium-10molybdenum alloy for surgical implant applications (UNS R30035)
- ASTM F620-06
- Standard specification for alpha plus beta titanium alloy forgings for surgical implants
- ASTM F621-08
- Standard specification for stainless steel forgings for surgical implants
- ASTM F648-07e1
- Standard specification for ultra-high-molecular weight polyethylene powder and fabricated form for surgical implants
- ASTM F67-06
- Standard specification for unalloyed titanium for surgical implant applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
- ASTM F688-05
- Standard specification for wrought cobalt-35 nickel-20 chromium-10 molybdenum alloy plate, sheet, and foil for surgical implants (UNS R30035)
- ASTM F75-12
- Standard specification for cobalt-28chromium-6molybdenum alloy castings and casting alloy for surgical implants (UNS R30075)
- ASTM F799-11
- Standard specification for cobalt-28chromium-6molybdenum alloy forgings for surgical implants (UNS R31537, R31538, R31539)
- ASTM F899-12
- Standard specification for wrought stainless steel for surgical instruments
- ASTM F90-09
- Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy for surgical implant applications (UNS R30605)
- ASTM F961-08
- Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy forgings for surgical implants (UNS R30035)
- ISO 3826-1:2003
- Plastic collapsible containers for human blood and blood components – Part 1: Conventional containers
- ISO 5832-1:2007
- Implants for Surgery – Metallic materials – Part 1: Wrought stainless steel
- ISO 5832-1:2007/Corr1:2008
- ISO 5832-2:1999
- Implants for surgery – Metallic materials – Part 2: Unalloyed titanium
- ISO 5832-3:1996
- Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- ISO 5832-4:1996
- Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy
- ISO 5832-5:2005
- Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
- ISO 5832-6:1997
- Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
- ISO 5832-9:2007
- Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless steel
- ISO 5832-11:1994
- Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 7-niobium alloy
- ISO 5832-12:2007
- Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum alloy
- ISO 5832-12:2007/Cor.1:2008
- ISO 5834-2:2011
- Implants for surgery – Ultra-high molecular weight polyethylene – Part 2: Moulded forms
- ISO 6474-1:2010
- Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina
- ISO 6474-2:2012
- Implants for surgery - Ceramic materials - Part 2: Composite materials based on a highpurity alumina matrix with zirconia reinforcement
- ISO 7153-1:1991
- Surgical instruments – Metallic materials – Part 1: Stainless steel
- ISO 7153-1:1991/Amd.1:1999
- ISO 13402:1995
- Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure
- ISO 13782:1996
- Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant applications
Ophthalmology
- ANSI Z80.7:2002
- Ophthalmic optics – Intraocular lenses
- ISO 11979-1:2006
- Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary
- ISO 11979-2:2014
- Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
- ISO 11979-3:2006
- Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test methods
- ISO 11979-5:2006
- Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility
- ISO 11979-6:2007
- Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability
- ISO 11979-7:2006
- Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations
- ISO 11979-7:2006/Amd.1:2012
- ISO 11979-8:2006
- Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements
- ISO 11979-8:2006/Amd.1:2011
- ISO 11980:2009
- Ophthalmic optics – Contact lenses and contact lens care products – Guidance for clinical investigations
- ISO 15004-2:2007
- Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection
- ISO 18369-1:2006
- Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and recommendations for labelling specifications
- ISO 18369-1:2006/Amd.1:2009
- ISO 18369-2:2006
- Ophthalmic optics – Contact lenses – Part 2: Tolerances
- ISO 18369-3:2006
- Ophthalmic optics – Contact lenses – Part 3: Measurement methods
- ISO 18369-4:2006
- Ophthalmic optics – Contact lenses – Part 4: Physicochemical properties of contact lens materials
- IEC 80601-2-58:2016- Ed.2.1
- 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
Orthopaedics
- ASTM F1044-05
- Standard test method for shear testing of calcium phosphate coatings and metallic coatings
- ASTM F1089-10
- Standard test method for corrosion of surgical instruments
- ASTM F1147-05
- Standard test method for tension testing of calcium phosphate and metal coatings
- ASTM F1160-14
- Standard test method for shear and bending fatigue testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coatings
- ASTM F1377-13
- Standard specification for cobalt-28chromium-6molybdenum powder for coating of orthopedic Implants (UNS R30075)
- ASTM F1609-08 (2014)
- Standard Specification for calcium phosphate coatings for implantable materials
- ASTM F1717-14
- Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F1798-13
- Standard Test Method for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants
- ASTM F1800-12
- Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
- ASTM F1801-97 (2004)
- Standard practice for corrosion fatigue testing of metallic implant materials
- ASTM F1829-17
- Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
- ASTM F1875-98 (R2014)
- Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- ASTM F2028-14
- Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
- ASTM F2077-11
- Test Methods For Intervertebral Body Fusion Devices
- ASTM F2267-04 (2011)
- Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM F2582-14
- Standard Test Method for Impingement of Acetabular Prostheses
- ASTM F2665-09 (R2014)
- Standard Specification for Total Ankle Replacement Prosthesis
- ASTM F2943-14
- Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
- ASTM F746-04 (2014)
- Standard test method for pitting or crevice corrosion of metallic surgical implant materials
- ASTM F86-13
- Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
- ASTM F897-02 (2013)
- Standard test method for measuring fretting corrosion of osteosynthesis plates and screws
- ASTM F983-86 (2013)
- Standard practice for permanent marking of orthopaedic implant components
- ISO 5838-1:2013
- Implants for surgery - Metallic skeletal pins and wires Part 1: General requirements
- ISO 5838-2:1991
- Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions
- ISO 5838-3:1993
- Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires
- ISO 7153-1:1991
- Surgical instruments – Metallic materials – Part 1: Stainless steel
- ISO 7153-1:1991/Amd.1:1999
- ISO 7206-4:2010
- Implants for surgery partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components
- ISO 7206-6:2013
- 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 9583:1993
- Implants for surgery – Non-destructive testing – Liquid penetrant inspection of metallic surgical implants
- ISO 14242-1:2012
- 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 14242-2:2000
- Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
- ISO 14243-1:2009
- 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 14243-2:2009
- Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
- ISO 14243-3:2004
- 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 14630:2012
- Non-active surgical implants - General requirements
Radiology
- AIUM/NEMA UD 2:2004 (R2009)
- Acoustic output measurement standard for diagnostic ultrasound equipment
- AIUM/NEMA UD 3:2004
- Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment
- IEC 60601-1-3:2013
- Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-28:2010-Ed.2.0
- Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-2-37:2015
- Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 60601-2-43:2010-Ed.2.0
- Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
- IEC 60601-2-44:2016
- Medical electrical equipment - Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
- IEC 60601-2-54:2015
- Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Sterilization
- ASTM F1980-07
- Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- CAN/CSA Z17665-1-09:2009:2009
- 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 11135:2014
- Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-1:2006
- Sterilization of health care products – Radiation – Part 1: Requirement for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013
- Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
- ISO 11137-3:2006
- Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects
- ISO 11138-1:2006
- Sterilization of health care products – Biological indicators – Part 1: General
- ISO 11138-2:2006
- Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11138-3:2006
- Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
- ISO 11607-1:2006
- Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2006
- Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 11737-1:2006
- Sterilization of medical devices – Microbiological methods – Part 1: Determination of population of microorganisms on products
- ISO 11737-1:2006/Cor.1:2007
- ISO 14160:2011
- 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
- ISO 14937:2009
- 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 17664:2004
- Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ISO 17665-1:2006
- Sterilization of health care products – Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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