Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

List of Recognized Standards for Medical Devices

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Notice

September 26, 2014
Our file number: 14-111695-423

Subject: Announcement of Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices

Health Canada is pleased to announce proposed changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.

The proposed changes consist of:

  1. 15 new standards to be added;
  2. 11 new editions of currently recognized standards to replace previous editions;
  3. 14 standards to be removed.

The TPD Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations is posted on the Health Canada website.

For further information on the List of Recognized Standards, please contact:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
2934 Baseline Road, Tower B
Address Locator 3403A
Ottawa, Ontario
K1A 0K9

Telephone: 613-954-0298
Fax: 613-957-9969
E-mail: Standards.Committee@hc-sc.gc.ca

List of Recognized Standards for Medical Devices

Date Adopted 2002/04/11
Revised Date 2014/09/19
Effective Date 2014/10/02

Table of Contents

Changes to the List of Recognized Standards

Standards Added

  • 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 F2943-13
    Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
  • CLSI EP24-A2:2012
    Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline Second Edition
  • CLSI MM01-A3:2012
    Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline
  • CLSI MM06-A2:2010
    Quantitative Molecular Methods for Infectious Diseases
  • IEC 60601-1-10:2007-Ed.1.1
    Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  • 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 8359:1996
    Oxygen Concentrators for medical use - Safety requirements ISO 8359/Amd.1:2012
  • ISO 10282:2002
    Single-Use Sterile Surgical Rubber Gloves - Specification - Second Edition
  • ISO 14242-1:2012
    Implants for surgery - Wear of total hipjoint 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

Standards Updated

  • ASTM F1717-13
    Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1800-12
    Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
  • ASTM F86-13
    Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
  • ISO 5838-1:2013
    Implants for Surgery - Skeletal Pins and Wires - Part 1: Material and Mechanical Requirements
  • ISO 5841-3:2013
    Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers - Third Edition
  • 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 14630:2012
    Non-active surgical implants - General requirements
  • ISO 15197:2013
    In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Standards Removed

  • CLSI GP10-A:1995 (R2001)
    Assessment of the clinical accuracy of laboratory tests using Receiver Operating Characteristic (ROC) plots; Approved guideline
  • CLSI I/LA6-A:1997
    Detection and quantitation of rubella IgG antibody: Evaluation and performance criteria for multiple component test products, specimen handling, and use of test products in the clinical laboratory; Approved guideline
  • CLSI MM01-A2:2006
    Molecular diagnostic methods for genetic diseases; Approved guideline
  • EN 13640:2002
    Stability testing of in vitro diagnostic reagents
  • IEC 60601-2-4-:2002-Ed.2.0
    Medical electrical equipment Part 2-4: Particular requirements for the safety of cardiac defibrillators
    IEC 60601-2-4:2002-Ed.2.0/Cor.1:2004
  • IEC 60601-2-23:1999-Ed.3.0
    Medical electrical equipment Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
  • IEC 60601-2-27:2005-Ed.2.0
    Medical electrical equipment Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
  • IEC 60601-2-28:1993-Ed.1.0
    Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
  • IEC 60601-2-33:2008-Ed.2.2
    Medical electrical equipment Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  • IEC 60601-2-34:2000-Ed.2.0
    Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
  • IEC 60601-2-43:2000-Ed.1.0
    Medical electrical equipment Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
  • ISO 7206-8:1995
    Implants for surgery Partial and total hip joint prostheses Part 8: Endurance performance of stemmed femoral components with application of torsion
  • ISO 10555-2:2002
    Sterile, Single-Use Intravascular Catheters - Part 2: Angiographic Catheters

List of Recognized Standards

Anaesthetic and Respiratory

  • 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 9919:2005
    Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
  • ISO 21647:2004
    Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
    ISO 21647:2004/Cor.1:2005
  • 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 - First Edition
  • 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 - First Edition

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 5840:2005
    Cardiovascular implants - Cardiac valve prostheses
  • ISO 5841-3:2013
    Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    - Third Edition
  • ISO 7198:1998
    Cardiovascular implants - Tubular vascular prostheses
  • 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 14708-1:2000
    Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
  • ISO 14708-2:2005
    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 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 - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
  • 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
    Dental water-based cements - Part 2: Light-activated cements
  • ISO 10271:2011
    Dental metallic materials - Corrosion test methods for metallic materials
  • ISO/TS 11405:2003
    Dental materials - Testing of adhesion to tooth structure
  • ISO 14801:2007
    Dentistry - 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

Electromedical

  • ANSI/AAMI DF80:2003
    Medical electrical equipment - Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators]
  • ANSI/AAMI PC69:2000
    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
  • ANSI/AAMI PC69:2007
    Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
    ANSI/AAMI PC69:2007/ERTA:2008
  • CSA C22.2 NO. 601.1 M90 (R2006)
    Medical electrical equipment - Part 1: General requirements for safety (adopted amendment 2:1995 to IEC 601-1:1990)
  • CSA C22.2 NO 60601-1-08
    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • CSA C22.2 NO 60601-1-2-08
    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • CSA C22.2 NO. 60601-1-2A-03 (R2006)
    Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (Adopted Amendment 1:2004 to IEC 60601-1-2:2001)
  • 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 60601-1:1988-Ed.2.0
    Medical electrical equipment - Part 1: General requirements for basic safety
    IEC 60601-1:1988-Ed.2.0/Amd.1:1991
    IEC 60601-1:1988-Ed.2.0/Amd.2:1995
    IEC 60601-1:1988-Ed.2.0/Cor.1:1995
  • 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 60601-1-2:2004-Ed.2.1
    Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard - Electromagnetic compatibility - Requirements and tests
  • 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 60601-1-4:2000-Ed.1.1
    Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
  • IEC 60601-1-6:2006-Ed.2.0
    Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral Standard: Usability
  • IEC 60601-1-6:2010-Ed.3.0
    Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability
  • IEC 60601-1-8:2006-Ed.2.0
    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 1.1
    Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  • 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 - Edition 3.0
  • 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 60601-2-10:1987-Ed.1.0
    Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
    IEC 60601-2-10:1987-Ed.1.0/Cor.1:1987
    IEC 60601-2-10:1987-Ed.1.0/Amd.1:2001
  • 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 - Edition 3.0
  • IEC 60601-2-24:1998-Ed.1.0
    Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
  • IEC 60601-2-25:1993-Ed.1.0
    Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
    IEC 60601-2-25:1993-Ed.1.0/Amd.1:1999
  • 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 - Edition 2.0
  • IEC 60601-2-26:2002-Ed.2.0
    Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
  • 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 - Edition 3.0
  • 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 - Edition 3.0
    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 - Edition 3.0
    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 - Edition 3.0
  • IEC 60601-2-36:1997-Ed.1.0
    Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
  • IEC 60601-2-47:2001-Ed.1.0
    Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
  • 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 - Edition 2.0
  • 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 - Edition 2.0
  • 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 60601-2-51:2003-Ed.1.0
    Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
  • IEC 60825-1:2007-Ed.2.0
    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

General

  • ASME PVHO-1:2007
    Safety standard for pressure vessels for human occupancy
  • ASTM F1929-98 (2004)
    Standard test method for detecting seal leaks in porous medical packaging by dye penetration
  • CSA Z364.2.2-03
    Water treatment equipment and water quality requirements for hemodialysis
  • CSA-ISO 14971-07
    Medical devices Application of risk management to medical devices
  • IEC 62304:2006-Ed.1.0
    Medical device software software life cycle processes
  • ISO 10282:2002
    Single-Use Sterile Surgical Rubber Gloves - Specification - Second Edition
  • 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
    Concentrates 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 14971:2007
    Medical devices - Application of risk management to medical devices
  • ISO 22442-1:2007
    Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
  • ISO 22442-2:2007
    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 C28-A3:2008
    Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline
  • CLSI C46-A2:2009
    Blood gas and pH analysis and related measurements; Approved guideline
  • CLSI EP5-A2:2004
    Evaluation of precision performance of quantitative measurement methods; 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 EP12-A2:2008
    User protocol for evaluation of qualitative test performance; Approved guideline
  • CLSI EP14-A2:2005
    Evaluation of matrix effects; Approved guideline
  • CLSI EP17-A:2004
    Protocols for determination of limits of detection and limits of quantitation; 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 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 H49-A:2004
    Point-of-care monitoring of anticoagulation therapy; Approved guideline
  • 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 MM07-A:2004
    Fluorescence in situ hybridization (FISH) methods for medical genetics; Approved guideline
  • 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
  • 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
  • IEC 61326-1:2005-Ed.1.0
    Electrical equipment for measurement, control and laboratory use - EMC requirements Part 1: General requirements
    IEC 61326-1:2005-Ed.1.0/Cor.1:2008
  • IEC 61326-2-6:2005-Ed.1.0
    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

Materials

  • ASTM F67-06
    Standard specification for unalloyed titanium for surgical implant applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
  • ASTM F75-12
    Standard specification for cobalt-28chromium-6molybdenum alloy castings and casting alloy for surgical implants (UNS R30075)
  • ASTM F90-09
    Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy for surgical implant applications (UNS R30605)
  • 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 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 F688-05
    Standard specification for wrought cobalt-35 nickel-20 chromium-10 molybdenum alloy plate, sheet, and foil for surgical implants (UNS R30035)
  • 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 F961-08
    Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy forgings for surgical implants (UNS R30035)
  • 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 F1472-08e1
    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
  • CSA Z900.1-03 (R2008)
    Cells tissues, and organs for transplantation and assisted reproduction: General requirements
  • 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 - 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 11979-2:1999
    Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
    ISO 11979-2:1999/Cor.1:2003
  • 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

Orthopaedics

  • ASTM F86-13
    Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
  • ASTM F746-04
    Standard test method for pitting or crevice corrosion of metallic surgical implant materials
  • ASTM F897-02 (2007)
    Standard test method for measuring fretting corrosion of osteosynthesis plates and screws
  • ASTM F983-86 (2009)
    Standard practice for permanent marking of orthopaedic implant components
  • 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 F1160-05
    Standard test method for shear and bending fatigue testing of calcium phosphate and metallic medical and composite calcium phosphate/metallic coatings
  • ASTM F1377-08
    Standard specification for cobalt-28chromium-6molybdenum powder for coating of orthopedic Implants (UNS R30075)
  • ASTM F1609-08
    Standard Specification for calcium phosphate coatings for implantable materials
  • ASTM F1717-13
    Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1798-97 (2008)
    Standard guide 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 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 F2943-13
    Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
  • ISO 5838-1:2013
    Implants for Surgery - Skeletal Pins and Wires - Part 1: Material and Mechanical 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 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 14630:2012
    Non-active surgical implants - General requirements
  • ISO 14242-1:2012
    Implants for surgery Wear of total hipjoint 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

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 60601-1-3:2008-Ed.2.0
    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 - Edition 2.0
  • IEC 60601-2-37:2007-Ed.2.0
    Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - Edition 2.0
  • 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 - Edition 2.0
  • IEC 60601-2-44:2009-Ed.3.0
    Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography - Edition 3.0
    IEC 60601-2-44:2009-Ed.3.0/Cor.1:2010
  • IEC 60601-2-54:2009-Ed.1.0
    Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy - Edition 1.0
    IEC 60601-2-54:2009-Ed.1.0/Cor.1:2010

Sterilization

  • ASTM F1980-07
    Standard guide for accelerated aging of sterile medical device packages sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
  • CSA Z11135-1-09
    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • 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 11135-1:2007
    Sterilization of health care products - Ethylene oxide - Part 1: 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 11137-2:2006
    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
    ISO 11137-2:2006/Cor.1:2009
  • 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
  • ISO 11138-3:2006
    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization
  • 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: Estimation of population of microorganisms on products
    ISO 11737-1:2006/Cor.1:2007
  • 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