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List of Recognized Standards

Date Adopted 2002/04/11
Revised Date 2010/04/20
Effective Date 2010/07/26

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.

(PDF Version - 138 K)

Changes to the List of Recognized Standards
List of Recognized Standards

Changes to the List of Recognized Standards

Standards Added

ASTM F2565-06
Standard guide for extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications

CISPR 11:2009-Ed.5.0
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

IEC 60601-2-16:1998-Ed.2.0
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

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 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 less than or equal to 1A 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 61000-4-5:2005-Ed.2.0
Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Electrical fast transient/burst immunity test
IEC 61000-4-5:2005-Ed.2.0/Cor.1:2009

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 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 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

ISO 18369-1:2006
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications

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

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 7198:1998
Cardiovascular implants - Tubular vascular prostheses

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Standards Updated

Anaesthetic and Respiratory

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 7199:2009
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

CSA Z9919-07
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

Cardiovascular

ISO 10555-4:1996
Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters supplied in the sterile condition, and intended for single use
ISO 10555-4:1996/Cor.1:2002

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 14801:2007
Dentistry fatigue test for endosseous dental implants

ISO 4049:2009
Dentistry - Polymer-based filling, restorative and luting materials

ISO 6872:2008
Dentistry - Ceramic materials

ISO 7405:2008
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

ISO 9917-1:2007
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements

Electromedical

IEC 60601-1:2005-Ed.3.0
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005/Cor.1:2006

CSA C22.2 NO 60601-1 CAN/CSA:2008
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007-Ed.3.0
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard - Electromagnetic compatibility - Requirements and tests

CSA C22.2 NO 60601-1-2 CAN/CSA:2008
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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 60601-2-4:2002-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 60601-2-5:2009-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/Amd.1:1987
IEC 60601-2-10:1987-Ed.1.0/Cor.1:1987

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 60601-2-22:1995-Ed.1.0
Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser 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 60601-2-31:2008-Ed.2.0
Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-33:2002-Ed.2.1
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33:2002-Ed.2.0/Amd.1:2005
IEC 60601-2-33:2002-Ed.2.0/Amd.2:2007

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 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 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 61000-4-2:2008-Ed.2.0
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

IEC 61000-4-3:2008-Ed.3.1
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test

IEC 61000-4-4:2004-Ed.2.0
Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
IEC 61000-4-4:2004-Ed.2.0/Cor.1:2006
IEC 61000-4-4:2004-Ed.2.0/Cor.2:2007

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

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

General

ISO 11193-1:2008
Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

ASME PVHO-1:2007
Safety standard for pressure vessels for human occupancy

ISO 14971:2007
Medical devices - Application of risk management to medical devices

CAN/CSA-ISO 14971-07
Medical devices - Application of risk management to medical devices

In Vitro Diagnostic

CLSI EP12-A2:2008
User protocol for evaluation of qualitative test performance; Approved guideline

CLSI H20-A2:2007
Reference leukocyte differential count (proportional) and evaluation of instrumental methods; Approved standard

IEC 61010-1:2001-Ed.2.0
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-1:2001-Ed.2.0/Cor.1:2002
IEC 61010-1:2001-Ed.2.0/Cor.2:2003

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

Materials

ASTM F1108-04 (2009)
Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical implants (UNS R56406)

ASTM F136-08e1
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 F1472-08e1
Standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications (UNS R56400)

ASTM F1713-08
Standard specification for wrought titanium-13niobium-13zirconium alloy for surgical implant applications (UNS R58130)

ASTM F560-08
Standard specification for unalloyed tantalum for surgical implant applications (UNS R05200, UNS R05400)

ASTM F648-07e1
Standard specification for ultra-high-molecular weight polyethylene powder and fabricated form for surgical implants

ASTM F961-08
Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy forgings for surgical implants (UNS R30035)

ASTM F1091-08
Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy surgical fixation wire (UNS R30605)

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 F1537-08
Standard specification for wrought cobalt-28chromium-6molybdenum alloy for surgical implants (UNS R31537, UNS R31538, and UNS R31539)

ASTM F1580-07
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 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 F67-06
Standard specification for unalloyed titanium for surgical implant applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

ASTM F745-07
Standard specification for 18chromium-12.5nickel-2.5 molybdenum stainless steel for cast and solution-annealed surgical implant applications

ASTM F75-07
Standard specification for cobalt-28chromium-6molybdenum alloy castings and casting alloy for surgical implants (UNS R30075)

ASTM F799-06
Standard specification for cobalt-28chromium-6molybdenum alloy forgings for surgical implants (UNS R31537, R31538, R31539)

ASTM F899-09
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)

ISO 5832-5:2005
Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy

ISO 5832-9:2007
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel

ISO 5832-12:2007
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy

ISO 5834-2:2006
Implants for surgery - Ultra-high molecular weight polyethylene - Part 2: Moulded forms

CAN/CSA-Z900.1-03:2003 (R2008)
Cells, tissues, and organs for transplantation and assisted reproduction: General requirements

Ophthalmology

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 11980:2009
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

Orthopaedics

ASTM F1609-08
Standard specification for calcium phosphate coatings for implantable materials

ASTM F1717-09
Standard test methods for spinal implant constructs in a vertebrectomy model

ASTM F1800-07
Standard test method for cyclic fatigue testing of metal tibial tray components of total knee joint replacements

ASTM F1377-08
Standard specification for cobalt-28chromium-6molybdenum powder for coating of orthopaedic implants (UNS R30075)

ASTM F1612-95 (2005)
Standard practice for cyclic fatigue testing of metallic stemmed hip arthroplasty femoral components with torsion

ASTM F1798-97 (2008)
Standard guide for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants

ASTM F86-04 (2009)
Standard practice for surface preparation and marking of metallic surgical implants

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

ISO 14630:2008
Non-active surgical implants - General requirements

ISO 5838-3:1996
Implants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires

Radiology

AIUM/NEMA UD 2-2004 (R2009)
Acoustic output measurement standard for diagnostic ultrasound equipment

IEC 60601-1-3:2008-Ed.2.0
Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

IEC 60601-2-37:2007-Ed.2.0
Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-44:2009-Ed.3.0
Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

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

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 11137-2:2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137:2006/Cor.1:2009

ISO 11138-1:2006
Sterilization of health care products - Biological indicators - Part 1: General requirements

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 11737-1:2006
Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products
ISO 11737:2006/Cor.1:2007

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Standards Deleted

CAN/CSA-Z168.5.1-97 (R2001)
Anaesthesia ventilators

ISO 11196:1995
Anaesthetic gas monitors
ISO 11196:1995/Cor.1:1997

CSA 11196-98 (R2003)
Anaesthetic gas monitors

CSA 10993-1-01
Biological evaluation of medical devices - Part 1: Evaluation and testing

CSA 10993-2-97 (R2001)
Biological evaluation of medical devices - Part 2: Animal welfare requirements

CSA 10993-3-97 (R2001)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

CSA 10993-4-97 (R2001)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

CSA 10993-5-01
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

CSA 10993-6-97 (R2001)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

CSA 10993-7-98 (R2002)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

CSA 10993-10-98 (R2003)
Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization

CSA 10993-11-98 (R2002)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

CSA 10993-12-98 (R2002)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

CSA 5841-3-01
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers

ASTM F1585-00
Standard guide for integrity testing of porous barrier medical packages

IEC 60601-2-38:1996-Ed.1.0
Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds
IEC 60601-2-38:1996-Ed.1.0/Amd.1:1999

ASTM F1341-99
Standard specification for unalloyed titanium wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for surgical implant applications

ASTM F603-00
Standard specification for high-purity dense aluminum oxide for surgical implant application

ISO 10338:1996
Optics and optical instruments - Contact lenses - Determination of curvature

ISO 10340:1995
Optics and optical instruments - Contact lenses - Method for determining the extractable substances

ISO 10344:1996
Optics and optical instruments - Contact lenses - Saline solution for contact lens testing

ISO 9339-1:1996
Optics and optical instruments - Contact lenses - Determination of the thickness - Part 1: Rigid contact lenses

ISO 9340:1996
Optics and optical instruments - Contact lenses - Determination of strains for rigid contact lenses

ISO 9341:1996
Optics and optical instruments - Contact lenses - Determination of inclusions and surface imperfections for rigid contact lenses

ISO 9913-1:1996
Optics and optical instruments - Contact lenses - Part 1: Determination of oxygen permeability and transmissibility with the FATT method

ASTM F1659-95
Standard test method for bending and shear fatigue testing of calcium phosphate coatings on solid metallic substrates

ISO 11134:1994
Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization

ISO 11135:1994
Medical devices - Validation and routine control of ethylene oxide sterilization
ISO 11135:1994/Cor.1:1994

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List of Recognized Standards

Anaesthetic and Respiratory

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 7199:2009
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

ISO 9919:2005
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

CSA Z9919-07
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

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Biocompatibility

ISO 10993-1:2003
Biological evaluation of medical devices - Part 1: Evaluation and testing

ISO 10993-2:1992
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 10993-5:1999
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-6:1994
Biological evaluation of medical devices – Part 6: Tests for local effects after implantation

ISO 10993-7:1995
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

ISO 10993-9:1999
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

ISO 10993-10:2002
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

ISO 10993-11:1993
Biological Evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO 10993-12:2002
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

ISO 10993-13:1998
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 10993-16:1997
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

ASTM F981-04
Standard practice for assessment of compatibility of biomaterials for surgical implants with respect to effect of materials on muscle and bone

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Cardiovascular

ISO 10555-1:1995
Sterile, single-use intravascular catheters - Part 1: General requirements
ISO 10555-1:1995/Amd.1:1999
ISO 10555-1:1995/Amd.2:2004

ISO 10555-2:1996
Sterile, single-use intravascular catheters - Part 2: Angiographic catheters
ISO 10555-2:1996-Ed.1.0/Cor.1:200

ISO 10555-3:1996
Sterile, single-use intravascular catheters - Part 3: Central venous catheters
ISO 10555-3:1996/Cor.1:2002

ISO 10555-4:1996
Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters supplied in the sterile condition, and intended for single use
ISO 10555-4:1996/Cor.1:2002

ISO 10555-5:1996
Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters
ISO 10555-5:1996/Amd.1:1999
ISO 10555-5:1996/Cor.1:2002

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 25539-1:2003
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
ISO 25539-1:2003/Amd.1:2005

ISO 5840:2005
Cardiovascular implants - Cardiac valve prostheses

CSA 5840-98 (R2002)
Cardiovascular implants - Cardiac valve prostheses

ISO 5841-3:2000
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 5841-3:2000/Cor.1:2003

ISO 7198:1998
Cardiovascular implants - Tubular vascular prostheses

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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 14801:2007
Dentistry - Fatigue test for endosseous dental implants

ISO 10271:2001
Dental metallic materials - Corrosion test methods
ISO 10271:2001/Cor.1:2005

ISO 4049:2009
Dentistry - Polymer-based restorative materials

ISO 6872:2008
Dentistry - Ceramic materials

ISO 6876:2001
Dental root canal sealing materials

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 9917-1:2007
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements

ISO 9917-2:1998
Dental water-based cements - Part 2: Light-activated cements

ISO 3107:2004
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
ISO 3107:2004/Cor.1:2006

ISO 6874:2005
Dentistry - Polymer-based pit and fissure sealants

ISO 6877:2006
Dentistry - Root-canal obturating points

ISO 22674:2006
Dentistry - Metallic materials for fixed and removable restorations and appliances

ISO 22794:2007
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

ISO 22803:2004
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file

ISO 24234:2004
Dentistry - Mercury and alloys for dental amalgam

ISO/TS 11405:2003
Dental materials - Testing of adhesion to tooth structure

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Electromedical

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 60601-1-2:2004-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 60601-1-4:1996-Ed.1.1
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-1-4:1996-Ed.1.1/Amd.1:1999

IEC 60601-1-6:2006-Ed.2.0
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

IEC 60601-1-8:2006-Ed.2.0
Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-2-2:2006-Ed.4.0
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

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 60601-2-5:2000-Ed.2.0
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

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 60601-2-16:1998-Ed.2.0
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-18:1996-Ed.2.0
Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
IEC 60601-2-18:1996/Amd.1:2000

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 60601-2-22:1995-Ed.2.0
Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment

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 60601-2-24:1998-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 60601-2-26:2002-Ed.2.0
Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

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 60601-2-30:1999-Ed.2.0
Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

IEC 60601-2-31:1994-Ed.1.0
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source
IEC 60601-2-31:1994-Ed.1.0/Amd.1:1998

IEC 60601-2-31:2008-Ed.2.0
Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-33:2002-Ed.2.0
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33:2002/Amd.1:2005
IEC 60601-2-33:2002/Amd.2:2007

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 60601-2-36:1997-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 60601-2-49:2001-Ed.1.0
Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

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 60529:2001-Ed.2.1
Degrees of protection provided by enclosures (IP Code)
IEC 60529:2001/Cor.1:2001
IEC 60529:2001/Cor.2:2007
IEC 60529:2001/Cor.3:2009

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 60825-1:2007-Ed.2.0
Safety of laser products - Part 1: Equipment classification and requirements

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 CAN/CSA:2008
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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 61000-3-2:2009-Ed.3.2
Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤16A per phase)
IEC 61000-3-2:2009-Ed.3.2/Cor.1:2009

IEC 61000-4-2:2001-Ed.1.2
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

IEC 61000-4-2:2008-Ed.2.0
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

IEC 61000-4-3:2006-Ed.3.0
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-3:2006/Amd.1:2007

IEC 61000-4-3:2008-Ed.3.1
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test

IEC 61000-4-4:2004-Ed.2.0
Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Surge immunity test
IEC 61000-4-4:2004-Ed.2.0/Cor.1:2006
IEC 61000-4-4:2004-Ed.2.0/Cor.2:2007

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 61000-4-6:2006-Ed.2.2
Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields

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

CISPR 11:2009-Ed.5.0
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

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

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General

ISO 14155-1:2003
Clinical investigation of medical devices for human subjects - Part 1: General requirements

ISO 14155-2:2003
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

IEC 62304:2006
Medical device software - software life cycle processes

CSA Z364.2.2-03
Water treatment equipment and water quality requirements for hemodialysis

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

ISO 11193-1:2008
Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

ISO 14971:2007
Medical devices - Application of risk management to medical devices

CAN/CSA-ISO 14971-07
Medical devices - Application of risk management to medical devices

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In Vitro Diagnostic

CLSI EP5-A2:2004
Evaluation of precision performance of quantitative measurement methods; Approved guideline

CLSI EP7-A2:2005
Interference testing in clinical chemistry

CLSI EP12-A2:2008
User protocol for evaluation of qualitative test performance; Approved guideline

CLSI H15-A3:2000
Reference and selected procedures for the quantitative determination of hemoglobin in blood; Approved standard

CLSI H20-A2:2007
Reference leukocyte differential count (proportional) and evaluation of instrumental methods; Approved standard

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 15197:2003
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

EN 13640:2002
Stability testing of in vitro diagnostic reagents

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Materials

ASTM F1088-04ae1
Standard specification for beta-tricalcium phosphate for surgical implantations