Proposed Changes to the Medical Devices Directorate’s Draft Guidance Document - List of Recognized Standards for Medical Devices
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Organization: Health Canada
Date published: 2021/01/15
Date adopted: 2002/04/11
Revised date: 2021/01/15
Effective date: 2021/01/15
Additional information
Table of Contents
Changes to the List of Recognized Standards
Standards Added
-
ISO 25539-2:2012-Ed.2.0
- Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
-
ISO 13116:2014-Ed.1.0
- Dentistry — Test Method for Determining Radio-Opacity of Materials
-
ISO 29022:2013-Ed.1.0
- Dentistry — Adhesion — Notched-edge shear bond strength test
-
IEC 60601-2-1:2014-Ed.3.1
- Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
-
IEC 62366-1:2015-Ed.1.0
- Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 62366-1/COR 1:2016
-
ASTM F2026-16
- Standard specification for polyetheretherketone (PEEK) polymers for surgical implant applications
-
ISO 11979-4:2008-Ed.2.0
- Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
- ISO 11979-4/Amd.1:2012
-
ISO 11979-10:2018-Ed.2.0
- Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
-
ISO TR 22979:2017-Ed.2.0
- Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
-
ASTM F2083-12
- Standard specification for knee replacement prosthesis
-
ASTM F2346-11
- Standard test methods for static and dynamic characterization of spinal artificial discs
-
ASTM F3140-17
- Standard test method for cyclic fatigue testing of metal tibial tray components of unicondylar knee joint replacements
-
ASTM F543-17
- Standard Specification and Test Methods for Metallic Medical Bone Screws
-
IEC 60601-2-45:2015-Ed.3.1
- Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Standards Updated
-
ISO 7199:2016-Ed.3.0
- Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
-
ISO 10993-1:2018-Ed.5.0
- Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- Note: Devices subject to Clause 5.3.2 may require additional testing beyond that which is specified in Clause 5.3.2
-
ISO 10555-1:2013-Ed.2.0
- Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
- ISO 10555-1/Amd.1:2017
-
ISO 25539-1:2017-Ed.2.0
- Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
-
ISO 4049:2019-Ed.5.0
- Dentistry – Polymer-based restorative materials
-
ISO 6872:2015-Ed.4.0
- Dentistry – Ceramic materials
- ISO 6872/Amd.1:2018
-
ISO 6874:2015-Ed.3.0
- Dentistry – Polymer-based pit and fissure sealants
-
ISO 7405:2018-Ed.3.0
- Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
-
ISO 9917-2:2017-Ed.3.0
- Dentistry - Water-based cements – Part 2: Resin-modified cements
-
ISO 14801:2016-Ed.3.0
- Dentistry — Implants — Dynamic loading test for endosseous dental implants
-
ISO 22674:2016-Ed.2.0
- Dentistry – Metallic materials for fixed and removable restorations and appliances
-
ISO 24234:2015-Ed.2.0
- Dentistry — Dental amalgam
-
ISO/TS 11405:2015-Ed.3.0
- Dental materials – Testing of adhesion to tooth structure
-
IEC 60601-2-22:2012-Ed.3.1
- Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
-
ISO 14708-3:2017-Ed.2.0
- Implants for Surgery - Active implantable medical devices -- Part 3: Implantable neurostimulators
-
ISO 11979-8:2017-Ed.3.0
- Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements
-
ASTM F1044-05
- Standard test method for shear testing of calcium phosphate coatings and metallic coatings
- ASTM F1044-05/(R 2017)
- ASTM F1044-05/(E 2018)
-
ASTM F1147-05
- Standard test method for tension testing of calcium phosphate and metal coatings
- ASTM F1147-05/(R 2017)
- ASTM F1147-05/(E 2017)
-
ASTM F1717-18
- Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
-
ASTM F1801-97
- Standard practice for corrosion fatigue testing of metallic implant materials
- ASTM F1801-97/(R 2014)
-
ASTM F2077-18
- Test Methods for Intervertebral Body Fusion Devices
-
ASTM F2267-04
- Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression
- ASTM F2267-04 /(R 2018)
-
ASTM F746-04
- Standard test method for pitting or crevice corrosion of metallic surgical implant materials
- ASTM F746-04 /(R 2014)
-
ISO 14242-1:2014-Ed.3.0
- 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 14242-1/Amd. 1: 2018
-
ISO 14242-2:2016-Ed.2.0
- Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
-
ISO 14243-2:2016-Ed.3.0
- Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
-
ISO 14243-3:2014-Ed.2.0
- 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
-
IEC 60601-2-28:2017-Ed.3.0
- Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
-
IEC 60601-2-43:2017-Ed.2.1
- Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
- IEC 60601-2-43/Amd.1:2017
-
ISO 11135:2014-Ed.2.0
- Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11135/Amd.1:2018
Standards Removed
-
ISO 9693:1999
- Metal-ceramic dental restorative systems
- ISO 9693/Amd.1:2005
-
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 62366:2014-Ed.1.1
- Medical devices – Application of usability engineering to 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 7199:2016-Ed.3.0
- Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators)
-
ISO 8359:1996-Ed.2.0
- Oxygen Concentrators for medical use - Safety requirements
- ISO 8359:1996-Ed.2.0/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 10993-1:2018-Ed.5.0
- Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- Note: Devices subject to Clause 5.3.2 may require additional testing beyond that which is specified in Clause 5.3.2
-
ISO 10993-2:2006-Ed.2.0
- Biological evaluation of medical devices – Part 2: Animal welfare requirements
-
ISO 10993-3:2003-Ed.2.0
- Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-
ISO 10993-4:2002-Ed.2.0
- Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
- ISO 10993-4:2002-Ed.2.0/Amd.1:2006
-
ISO 10993-5:2009-Ed.3.0
- Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-6:2007-Ed.2.0
- Biological evaluation of medical devices – Part 6: Tests for local effects after implantation
-
ISO 10993-7:2008-Ed.2.0
- Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
- ISO 10993-7:2008-Ed.2.0/Cor.1:2009
-
ISO 10993-9:2009-Ed.2.0
- Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
-
ISO 10993-10:2010-Ed.3.0
- Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11:2006-Ed.2.0
- Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
-
ISO 10993-12:2007-Ed.3.0
- Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
-
ISO 10993-13:2010-Ed.2.0
- Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices
-
ISO 10993-14:2001-Ed.1.0
- Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics
-
ISO 10993-15:2000-Ed.1.0
- Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
-
ISO 10993-16:2010-Ed.2.0
- Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables
-
ISO 10993-17:2002-Ed.1.0
- Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
-
ISO 10993-18:2005-Ed.1.0
- Biological evaluation of medical devices – Part 18: Chemical characterization of materials
Cardiovascular
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ISO 5840-1:2015-Ed.1.0
- Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
-
ISO 5840-2:2015-Ed.1.0
- Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - Surgically implanted heart valve substitutes
-
ISO 5840-3:2013-Ed.1.0
- Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
-
ISO 5841-3:2013-Ed.3.0
- Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
-
ISO 7198:2016-Ed.2.0
- Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
-
ISO 10555-1:2013-Ed.2.0
- Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
- ISO 10555-1:2013-Ed.2.0/Amd.1:2017
-
ISO 10555-3:2013-Ed.2.0
- Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
-
ISO 10555-4:2013-Ed.2.0
- Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
-
ISO 10555-5:2013-Ed.2.0
- Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
-
ISO 11318:2002-Ed.2.0
- 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-Ed.2.0
- Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers
-
ISO 14708-5:2010-Ed.1.0
- Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
-
ISO 14708-6:2010-Ed.1.0
- Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
-
ISO 25539-1:2017-Ed.2.0
- Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
-
ISO 25539-2:2012-Ed.2.0
- Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
-
ISO 27186:2010-Ed.1.0
- Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
Contraception
- ISO 4074:2002-Ed.1.0
- Natural latex rubber condoms – Requirements and test methods
- ISO 4074:2002-Ed.1.0/Cor.1:2003
- ISO 4074:2002-Ed.1.0/Cor.2:2008
Dental
-
ISO 3107:2011-Ed.4.0
- Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements
-
ISO 4049:2019-Ed.5.0
- Dentistry – Polymer-based restorative materials
-
ISO 6872:2015-Ed.4.0
- Dentistry – Ceramic materials
- ISO 6872:2015-Ed.4.0/Amd.1:2018
-
ISO 6874:2015-Ed.3.0
- Dentistry – Polymer-based pit and fissure sealants
-
ISO 6876:2012-Ed.3.0
- Dental root canal sealing materials
-
ISO 6877:2006-Ed.2.0
- Dentistry – Root-canal obturating points
-
ISO 7405:2018-Ed.3.0
- Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
-
ISO 9693-1:2012-Ed.1.0
- Dentistry – Compatibility testing – Part 1: Metal-ceramic systems
-
ISO 9917-1:2007-Ed.2.0
- Dentistry – Water-based cements – Part 1: Powder/liquid acid-base cements
-
ISO 9917-2:2017-Ed.3.0
- Dentistry - Water-based cements – Part 2: Resin-modified cements
-
ISO 10271:2011-Ed.2.0
- Dental metallic materials – Corrosion test methods for metallic materials
-
ISO 14801:2016-Ed.3.0
- Dentistry — Implants — Dynamic loading test for endosseous dental implants
-
ISO 22674:2016-Ed.2.0
- Dentistry – Metallic materials for fixed and removable restorations and appliances
-
ISO 22794:2007-Ed.1.0
- Dentistry – Implantable materials for bone filling and augmentation in oral and maxillofacial surgery – Contents of a technical file
-
ISO 22803:2004-Ed.1.0
- Dentistry – Membrane materials for guided tissue regeneration in oral and maxillofacial surgery – Contents of a technical file
-
ISO 24234:2015-Ed.2.0
- Dentistry –Dental amalgam
-
ISO/TS 11405:2015-Ed.3.0
- Dental materials – Testing of adhesion to tooth structure
-
ISO 13116:2014-Ed.1.0
- Dentistry - Test Method for Determining Radio-Opacity of Materials
-
ISO 29022:2013-Ed.1.0
- Dentistry - Adhesion - Notched-edge shear bond strength test
Electromedical
-
CAN/CSA C22.2 NO 60601-1-14:2014-Ed.3.0
- 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 60601-1-2:2014-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 60601-2-1:2014-Ed.3.1
- Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
-
IEC 60601-2-2:2009-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 60601-2-16:2008-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 60601-2-22:2012-Ed.3.1
- 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
- Note: 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-Ed.2.0
- Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer.
General
-
ASTM 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
- Standard test method for detecting seal leaks in porous medical packaging by dye penetration
- ASTM F1929-98:2004/(R 2004)
-
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-Ed.1.1
- Medical device software - Software life cycle processes
-
IEC 62366-1:2015-Ed.1.0
- Medical devices –Part 1: Application of usability engineering to medical devices
- IEC 62366-1:2015-Ed.1.0/COR 1:2016
-
ISO 10282:2002-Ed.2.0
- Single-Use Sterile Surgical Rubber Gloves - Specification
-
ISO 11193-1:2008-Ed.2.0
- Single-use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution
- ISO 11193-1:2008-Ed.2.0/Amd.1:2012
-
ISO 11663:2009-Ed.1.0
- Quality of dialysis fluid for haemodialysis and related therapies
-
ISO 13959:2009-Ed.2.0
- Water for haemodialysis and related therapies
-
ISO 14155:2011-Ed.2.0
- Clinical investigation of medical devices for human subjects – Good clinical practice
- ISO 14155:2011-Ed.2.0/Cor.1:2011
-
ISO 14971:2007-Ed.2.0
- Medical devices – Application of risk management to medical devices
-
ISO 22442-1:2015-Ed.2.0
- Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
-
ISO 22442-2:2015-Ed.2.0
- Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
-
ISO 22442-3:2007-Ed.1.0
- 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-Ed.1.0
- Water treatment equipment for haemodialysis applications and related therapies
-
SAI AS 2869:2008-Ed.4.0
- Tampons – Menstrual
In Vitro Diagnostic
-
CLSI C46-A2:2009-Ed.2.0
- Blood gas and pH analysis and related measurements; Approved guideline
-
CLSI EP12-A2:2008-Ed.2.0
- User protocol for evaluation of qualitative test performance; Approved guideline
-
CLSI EP14-A3:2014-Ed.3.0
- Evaluation of Commutability of Processed Samples; Approved guideline
-
CLSI EP17-A2:2012-Ed.2.0
- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved guideline
-
CLSI EP24-A2:2011-Ed.2.0
- Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition
-
CLSI EP25-A:2009-Ed.1.0
- Evaluation of stability of in vitro diagnostic reagents; Approved guideline
- (Note: Except: Section 7.1.3)
-
CLSI EP28-A3C:2010-Ed.3.0
- Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline
-
CLSI EP5-A3:2014-Ed.3.0
- Evaluation of precision of quantitative measurement procedures; Approved guideline
-
CLSI EP6-A:2003-Ed.1.0
- Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline
-
CLSI EP7-A2:2005-Ed.2.0
- Interference testing in clinical chemistry; Approved guideline
-
CLSI H15-A3:2000-Ed.3.0
- Reference and selected procedures for the quantitative determination of hemoglobin in blood; Approved standard
-
CLSI H20-A2:2007-Ed.2.0
- Reference leukocyte (WBC) differential count (proportional) and evaluation of instrumental methods; Approved standard
-
CLSI I/LA18-A2:2001-Ed.2.0
- Specifications for immunological testing for infectious diseases; Approved guideline
-
CLSI I/LA21-A2:2008-Ed.2.0
- Clinical evaluation of immunoassays; Approved guideline
-
CLSI MM01-A3:2012-Ed.3.0
- Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline
-
CLSI MM06-A2:2010-Ed.2.0
- Quantitative Molecular Methods for Infectious Diseases
-
CLSI MM12-A:2006-Ed.1.0
- Diagnostic nucleic acid microarrays; Approved guideline
-
CLSI MM13-A:2005-Ed.1.0
- Collection, transport, preparation, and storage of specimens for molecular methods; Approved guideline. Note: Except: Section 6.1.1
-
CLSI MM16-A:2006-Ed.1.0
- Use of external RNA controls in gene expression assays; Approved guideline
-
CLSI MM17-A:2008-Ed.1.0
- Verification and validation of multiplex nucleic acid assays; Approved guideline
-
CLSI POCT14-A:2004-Ed.1.0
- 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/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-Ed.2.0
- In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
-
ISO 23640:2011-Ed.1.0
- In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents
Manufacturing
-
ISO 13408-1:2008-Ed.2.0
- Aseptic processing of health care products - Part 1 : General requirements
-
ISO 13408-2:2003-Ed.1.0
- Aseptic processing of health care products - Part 2 : Filtration
-
ISO 13408-3:2006-Ed.1.0
- Aseptic processing of health care products - Part 3 : Lyophilization
-
ISO 13408-4:2005-Ed.1.0
- Aseptic processing of health care products - Part 4 : Clean-in-place technologies
-
ISO 13408-5:2006-Ed.1.0
- Aseptic processing of health care products - Part 5 : Sterilization in place
-
ISO 13408-6:2005-Ed.1.0
- Aseptic processing of health care products - Part 6 : Isolator systems
-
ISO 13408-7:2012-Ed.1.0
- Aseptic processing of health care products - Part 7 : Alternative processes for medical devices and combination products
-
ISO 14644-1:1999-Ed.1.0
- Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
-
ISO 14644-2:2000-Ed.1.0
- Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
-
ISO 14644-3:2005-Ed.1.0
- Cleanrooms and associated controlled environments - Part 3: Test methods
-
ISO 14644-4:2001-Ed.1.0
- Cleanrooms and associated controlled environments - Part 4: Design, Construction and Start Up
-
ISO 14644-5:2004-Ed.1.0
- Cleanrooms and associated controlled environments - Part 5: Operations
-
ISO 14644-6:2007-Ed.1.0
- Cleanrooms and associated controlled environments - Part 6: Vocabulary
-
ISO 14644-7:2004-Ed.1.0
- Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, glove boxes, isolators and mini-environments)
-
ISO 14644-8:2013-Ed.2.0
- Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
-
ISO 14644-9:2012-Ed.1.0
- Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
-
ISO 14644-10:2013-Ed.1.0
- Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
-
ISO 14698-1:2003-Ed.1.0
- Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
-
ISO 14698-2:2003-Ed.1.0
- Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data
Materials
-
ASTM F1088-04a
- Standard specification for beta-tricalcium phosphate for surgical implantations
-
ASTM F1088-04a:2010/(R 2010)ASTM F1091-08
- Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy surgical fixation wire (UNS R30605)
-
ASTM F1108-04
- Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical implants (UNS R56406)
- ASTM F1108-04:2009/(R 2009)
-
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 F2026-16
- Standard specification for polyetheretherketone (PEEK) polymers for surgical implant applications
-
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 F648-07
- Standard specification for ultra-high-molecular weight polyethylene powder and fabricated form for surgical implants
-
ASTM F648-07:2007/(e 2007)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-Ed.1.0
- Plastic collapsible containers for human blood and blood components – Part 1: Conventional containers
-
ISO 5832-1:2007-Ed.4.0
- Implants for Surgery – Metallic materials – Part 1: Wrought stainless steel
- ISO 5832-1:2007-Ed.4.0/Corr1:2008
-
ISO 5832-2:1999-Ed.3.0
- Implants for surgery – Metallic materials – Part 2: Unalloyed titanium
-
ISO 5832-3:1996-Ed.3.0
- Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
-
ISO 5832-4:1996-Ed.2.0
- Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy
-
ISO 5832-5:2005-Ed.3.0
- Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
-
ISO 5832-6:1997-Ed.2.0
- Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
-
ISO 5832-9:2007-Ed.2.0
- Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless steel
-
ISO 5832-11:1994-Ed.1.0
- Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 7-niobium alloy
-
ISO 5832-12:2007-Ed.2.0
- Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-molybdenum alloy
- ISO 5832-12:2007-Ed.2.0/Cor.1:2008
-
ISO 5834-2:2011-Ed.4.0
- Implants for surgery – Ultra-high molecular weight polyethylene – Part 2: Moulded forms
-
ISO 6474-1:2010-Ed.1.0
- Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina
-
ISO 6474-2:2012-Ed.1.0
- Implants for surgery - Ceramic materials - Part 2: Composite materials based on a highpurity alumina matrix with zirconia reinforcement
-
ISO 7153-1:1991-Ed.2.0
- Surgical instruments – Metallic materials – Part 1: Stainless steel
- ISO 7153-1:1991-Ed.2.0/Amd.1:1999
-
ISO 13402:1995-Ed.1.0
- Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure
-
ISO 13782:1996-Ed.1.0
- Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant applications
Neurology
-
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
-
ISO 14708-3:2017-Ed.2.0
- Implants for Surgery - Active implantable medical devices -- Part 3: Implantable neurostimulators
- ISO 14708-7:2013-Ed.1.0
- Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
Ophthalmology
-
ANSI Z80.7:2002
- Ophthalmic optics – Intraocular lenses
-
ISO 11979-1:2006-Ed.2.0
- Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary
-
ISO 11979-2:2014-Ed.2.0
- Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
-
ISO 11979-3:2006-Ed.2.0
- Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test methods
-
ISO 11979-4:2008-Ed.2.0
- Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
- ISO 11979-4:2008-Ed.2.0/Amd.1:2012
-
ISO 11979-5:2006-Ed.2.0
- Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility
-
ISO 11979-6:2007-Ed.2.0
- Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability
-
ISO 11979-7:2006-Ed.2.0
- Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations
- ISO 11979-7:2006-Ed.2.0/Amd.1:2012
-
ISO 11979-8:2017-Ed.3.0
- Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements
-
ISO 11979-10:2018-Ed.2.0
- Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
-
ISO TR 22979:2017-Ed.2.0
- Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
-
ISO 11980:2009-Ed.2.0
- Ophthalmic optics – Contact lenses and contact lens care products – Guidance for clinical investigations
-
ISO 15004-2:2007-Ed.1.0
- Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection
-
ISO 18369-1:2006-Ed.1.0
- Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and recommendations for labelling specifications
- ISO 18369-1:2006-Ed.1.0/Amd.1:2009
-
ISO 18369-2:2006-Ed.1.0
- Ophthalmic optics – Contact lenses – Part 2: Tolerances
-
ISO 18369-3:2006-Ed.1.0
- Ophthalmic optics – Contact lenses – Part 3: Measurement methods
-
ISO 18369-4:2006-Ed.1.0
- 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 F1044-05:2005/(R 2017)
- ASTM F1044-05:2005/(E 2018)
-
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 F1147-05:2005/(R 2017)
- ASTM F1147-05:2005/(E 2017)
-
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
- Standard Specification for calcium phosphate coatings for implantable materials
- ASTM F1609-08:2008/(R 2014)
-
ASTM F1717-18
- 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
- Standard practice for corrosion fatigue testing of metallic implant materials
- ASTM F1801-97:1997/(R 2014)
-
ASTM F1829-17
- Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
-
ASTM F1875-98
- Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- ASTM F1875-98:2014/(R 2014)
-
ASTM F2028-14
- Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
-
ASTM F2077-18
- Test Methods for Intervertebral Body Fusion Devices
-
ASTM F2267-04
- Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression
- ASTM F2267-04:2004/(R 2018)
-
ASTM F2346-11
- Standard test methods for static and dynamic characterization of spinal artificial discs
-
ASTM F2582-14
- Standard Test Method for Impingement of Acetabular Prostheses
-
ASTM F2665-09
- Standard Specification for Total Ankle Replacement Prosthesis
- ASTM F2665-09:2014/(R 2014)
-
ASTM F2943-14
- Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
-
ASTM F3140-17
- Standard test method for cyclic fatigue testing of metal tibial tray components of unicondylar knee joint replacements
-
ASTM F543-17
- Standard Specification and Test Methods for Metallic Medical Bone Screws
-
ASTM F746-04
- Standard test method for pitting or crevice corrosion of metallic surgical implant materials
- ASTM F746-04:2004/(R 2014)
-
ASTM F86-13
- Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
-
ASTM F897-02
- Standard test method for measuring fretting corrosion of osteosynthesis plates and screws
- ASTM F897-02:2002/(R 2013)
-
ASTM F983-86
- Standard practice for permanent marking of orthopaedic implant components
- ASTM F983-86:1986/(R 2013)
-
ISO 5838-1:2013-Ed.3.0
- Implants for surgery - Metallic skeletal pins and wires Part 1: General requirements
-
ISO 5838-2:1991-Ed.1.0
- Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions
-
ISO 5838-3:1993-Ed.1.0
- Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires
-
ISO 7153-1:1991-Ed.2.0
- Surgical instruments – Metallic materials – Part 1: Stainless steel
- ISO 7153-1:1991-Ed.2.0/Amd.1:1999
-
ISO 7206-4:2010-Ed.3.0
- 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-Ed.2.0
- 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-Ed.1.0
- Implants for surgery – Non-destructive testing – Liquid penetrant inspection of metallic surgical implants
-
ISO 14242-1:2014-Ed.3.0
- 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 14242-1:2014-Ed.3.0/Amd. 1: 2018
-
ISO 14242-2:2016-Ed.2.0
- Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
-
ISO 14243-1:2009-Ed.2.0
- 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 14243-2:2016-Ed.3.0
- Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
-
ISO 14243-3:2014-Ed.2.0
- 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-Ed.4.0
- Non-active surgical implants - General requirements
Radiology
-
AIUM/NEMA UD 2:2004
- Acoustic output measurement standard for diagnostic ultrasound equipment
- AIUM/NEMA UD 2:2004/(R 2009)
-
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-Ed.2.1
- 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: 2017-Ed.3.0
- 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-Ed.2.1
- Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
-
IEC 60601-2-43:2017-Ed.2.1
- Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
- IEC 60601-2-43:2017-Ed.2.1/Amd.1:2017
-
IEC 60601-2-44:2016-Ed.3.2
- Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
-
IEC 60601-2-45:2015-Ed.3.1
- Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
-
IEC 60601-2-54:2015-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
Sterilization
-
ASTM F1980-07
- Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
-
CAN/CSA Z17665-1-09:2009-Ed.1.0
- Sterilization of health care products – Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
-
ISO 11135:2014-Ed.2.0
- Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11135:2014-Ed.2.0/Amd.1:2018
-
ISO 11137-1:2006-Ed.1.0
- 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-Ed.3.0
- Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
-
ISO 11137-3:2006-Ed.1.0
- Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects
-
ISO 11138-1:2006-Ed.2.0
- Sterilization of health care products – Biological indicators – Part 1: General
-
ISO 11138-2:2006-Ed.2.0
- Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
-
ISO 11138-3:2006-Ed.2.0
- Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
-
ISO 11607-1:2006-Ed.1.0
- Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
-
ISO 11607-2:2006-Ed.1.0
- Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
-
ISO 11737-1:2006-Ed.2.0
- Sterilization of medical devices – Microbiological methods – Part 1: Determination of population of microorganisms on products
- ISO 11737-1:2006-Ed.2.0/Cor.1:2007
-
ISO 14160:2011-Ed.2.0
- Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization
-
ISO 14937:2009-Ed.2.0
- Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
-
ISO 17664:2004-Ed.1.0
- Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices
-
ISO 17665-1:2006-Ed.1.0
- Sterilization of health care products – Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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