List of Recognized Standards

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February 18, 2008

Published by authority of the
Minister of Health

Date Adopted 2002/04/11
Revised Date 2008/02/18
Effective Date 2008/02/18

TABLE OF CONTENTS

New Standards added to this revision of the List of Recognized Standards

Anaesthetic and Respiratory

Biocompatibility

Cardiovascular

Contraceptive Devices

Dental

Electromedical

General Hospital

In Vitro devices

Material Standard

Ophthalmology

Orthopaedics

Radiology

Sterilization

Standards added to this revision of the List of Recognized Standards

Electromedical
IEC 60601-1 - Ed. 2.0, Am1 (1991-11), Am2 (1995-03), Corr1 (1995-06)
Medical electrical equipment - Part 1: General requirements for safety

Electromedical
CAN/CSA-C22.2 NO. 601.1B-90 (R2006)
Medical electrical equipment - Part 1: General requirements for safety (Adopted Amendment 2:1995 to IEC 601-1:1990)

Electromedical
IEC 60601-1-2 Ed. 2.0, Ed. 2.1 : 2004-11-01
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard - Electromagnetic Compatibility - Requirements and Tests

Electromedical
CAN/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)

List of Recognized Standards

Anaesthetic and Respiratory

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

ISO 11196:1995
Anaesthetic gas monitors
Only available in English
ISO 11196:1995/Cor 1:1997

CSA 11196-98 (R2003)
Anaesthetic Gas Monitors

ISO 21647: 2004
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors -CORR 16264: August 2006
ISO 21647: 2004/Cor 2006

ISO 7199:1996
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 Z9919-94 (R2004)
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

Biocompatibility

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

CSA 10993-10- 98 (R2003) Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization

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

CSA 10993.11- 98 (R2002) Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

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 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

CSA 10993.4- 97 (R2001) 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

CSA 10993-5- 01 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

CSA 10993.6- 97 (R2001) 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

CSA 10993.7- 98 (R2002) 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 10993-1:2003 Biological evaluation of medical devices -- Part 1: Evaluation and testing

CSA 10993-1- 01 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing

ISO 10993-2:1992 Biological evaluation of medical devices -- Part 2: Animal welfare requirements

CSA 10993.2- 97 (R2001) 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

CSA 10993.3- 97 (R2001) Biological Evaluation of Medical Devices -- Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity

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

CSA 10993.12- 98 (R2002) Biological Evaluation of Medical Devices -- Part 12: Sample Preparation and Reference Materials

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 Only available in English

Cardiovascular

ISO 10555-1:1996
Sterile, Single-Use Intravascular catheters - Part 1: General Requirements
ISO 10555-1:1996-Ed.1.0/Amd.1:1999
ISO 10555-1:1996-Ed.1.0/Amd.2:2004

ISO 10555-2:1996
Sterile, Single-Use Intravascular catheters - Part 2: Angiographic Catheters
ISO 10555-2:1996-Ed.1.0/Cor.1:2002

ISO 10555-3:1996
Sterile, Single-Use Intravascular catheters - Part 3: Central Venous Catheters
ISO 10555-3:1996-Ed.1.0/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 10555-5:1996
Sterile, Single-Use Intravascular catheters - Part 5: Over-Needle Peripheral Catheters
ISO 10555-5:1996-Ed.1.0/Amd.1:1999
ISO 10555-5:1996-Ed.1.0/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-Ed.1.0
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

ISO 25539-1: 2003
Cardiovascular Implants - Endovascular devices - Part 1: Endovascular prostheses Amendment 1 (2005): Test methods
ISO 25539-1:2003-Ed.1.0/Amd.1:2005

ISO 5840:2005
Cardiovascular implants -- Cardiac valve prostheses
Only available in English

CSA 5840-98 (R2002)
Cardiovascular Implants - Cardiac Valve Prostheses
Only available in English

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

CSA 5841-3-01
Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers

Contraceptive Devices

ISO 4074:2002
Natural latex rubber condoms -- Requirements and test methods

Dental

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

ISO 14801:2003
Dentistry - Fatigue test for endosseous dental implants - First Edition

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

ISO 4049:2000
Dentistry -- Polymer-based filling, restorative and luting materials

ISO 6872:1995
Dental ceramic
ISO 6872:1995/Amd 1:1997

ISO 6876:2001
Dental root canal sealing materials

ISO 7405:1997
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 9917-2:1998
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 9917-1:2003
Dentistry -- Water-based cements -- Part 1: Powder/liquid acid-base cements

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

ISO/TS 11405: 2003
Dental Materials - Testing of Adhesion to Tooth Structure-Second Edition

Electromedical

IEC 60601-1 - Ed. 2.0, Am1 (1991-11), Am2 (1995-03), Corr1 (1995-06)
Medical electrical equipment - Part 1: General requirements for safety

CAN/CSA-C22.2 NO. 601.1B-90 (R2006)
Medical electrical equipment - Part 1: General requirements for safety (Adopted Amendment 2:1995 to IEC 601-1:1990)

IEC 60601-1 - Ed. 3.0 : 2005-12-15
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Ed. 2.0, Ed. 2.1 : 2004-11-01
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard - Electromagnetic Compatibility - Requirements and Tests

CAN/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 60601-1-2 Ed.3.0 March 2007
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 - Consol. Ed. 1.1 (incl. am1) : 2000-04-07
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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

IEC 60601-1-8 Ed.2.0 October 2006
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 Ed.4.0 July 2006
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

IEC 60601-2-4 - Ed. 2.0 : 2002-08
Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators

IEC 60601-2-5 - Ed. 2.0 : 2000-07-13
Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

IEC 60601-2-10 - Ed. 1.0 : 1987-12-30
Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-2-10-am1 - Ed. 1.0 : 2001-09-26

IEC 60601-2-18 - Ed. 2.0 : 1996-08-07
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
IEC 60601-2-18-am1 - Ed. 2.0 : 2000-07-13

IEC 60601-2-23 - Ed. 2.0 : 1999-12-10
Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
Only available in English

IEC 60601-2-24 - Ed. 1.0 : 1998-02-19
Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
Only available in English

IEC 60601-2-25 - Ed. 1.0 : 1993-03-19
Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs
IEC 60601-2-25-am1 - Ed. 1.0 : 1999-05-07

IEC 60601-2-26 - Ed. 2.0 : 2002-11
Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

IEC 60601-2-27 - Ed. 2.0 : 2005-08-29
Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

IEC 60601-2-30 - Ed. 2.0 : 1999-12-22
Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
Only available in English

IEC 60601-2-31 - Ed. 1.0 : 1994-10-12
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source
IEC 60601-2-31-am1 - Ed. 1.0 : 1998-01-30

IEC 60601-2-33 - Ed. 2.0 : 2002-05-22
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33-am1 - Ed. 2.0 : 2005-08-30

IEC 60601-2-34 - Ed. 2.0 : 2000-10
Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

IEC 60601-2-47 - Ed. 1.0 : 2001-07-10
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

IEC 60601-2-49 - Ed. 1.0 : 2001-07-24
Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

IEC 60601-2-51 - Ed. 1.0 : 2003-02-27
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

IEC 61000-4-2 Ed1.2 April 2001
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

IEC 61000-4-3 Ed3.0
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test

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

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

ANSI/AAMI DF80:2003
Medical electrical equipment, Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators]
Only available in English

ANSI/AAMI PC69:2000
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
Only available in English

IEC 60529 - Consol. Ed. 2.1 (incl. am1) : 2001-02-27
Degrees of protection provided by enclosures (IP Code)

General Hospital

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 Only available in English

IEC 62304 Ed.1.0 b: 2006 Medical device software - software life cycle processes

CSA Z364.2.2-03 Water Treatment Equipment and Water Quality Requirements for Hemodialysis -Third Edition Only available in English

ASTM PVHO-1: 2002 Safety Standard for Pressure Vessels for Human Occupancy

ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems -First edition

ISO 11607-2: 2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes -First edition

ASTM F1585-00 Standard Guide for Integrity Testing of Porous Barrier Medical Packages Only available in English

ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Only available in English

IEC 60601-2-38 - Ed. 1.0 : 1996-10-30
Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds
IEC 60601-2-38-am1 - Ed. 1.0 : 1999-12-17

ISO 11193-1:2002
Single-use medical examination gloves -- Part 1: Specification for gloves made from rubber latex or rubber solution
Only available in English
ISO 11193-1:2002/Cor 1:2005

ISO 14971:2000
Medical devices -- Application of risk management to medical devices
ISO 14971:2000/Amd 1:2003

CAN/CSA-ISO 14971-01
Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971A-01 (2003)

In Vitro Devices

CLSI EP5-A2 : 2004-08-20
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
Only available in English

CLSI EP7-A2 : 2005-11
Interference Testing in Clinical Chemistry
Only available in English

CLSI H15-A3 : 2000-12-01
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
Only available in English

CLSI H20-A : 1992-03-01
Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard
Only available in English

CLSI EP12-A : 2002-08-20
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline
Only available in English

IEC 61010-1: 2001-02-01
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements -Second Edition;
Corrigendum 1:05/2002; Corrigendum 2:04/2003

IEC 61010-2-101: 2002-01-01
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-101: Particular Requirements for in Vitro Diagnostic (IVD) Medical Equipment-First Edition

IEC 61326-1: 2005-12-01
Electrical equipment for measurement, control and laboratory use - EMC requirements Part 1: General requirements -Edition 1.0

ISO 15197:2003-05-01
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

EN 13640:2002
Stability of testing of in vitro diagnostic reagents

Material Standard

ASTM F1088-04 Rev A (E2006) Standard Specifications for Beta-Tricalcium Phosphate for Surgical Implantations Only available in English

ASTM F1108-04 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) Only available in English

ASTM F136-02 Rev A Standard Specification for Wrought Titanium - 6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) Only available in English

ASTM F138-03 Standard Specification for Wrought 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) Only available in English

ASTM F139-03 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) Only available in English

ASTM 1472-02 Rev A Standard Specification for Wrought Titanium-6Aluminum- 4Vanadium Alloy for Surgical Implant Applications (UNS R56400) Only available in English

ASTM F1713-03 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) Only available in English

ASTM F560-05 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Only available in English

ASTM F648-04 Standard Specification for Ultra-High-Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants Only available in English

ASTM F961-03 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) Only available in English

ASTM F1091-02 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) Only available in English

ASTM F1295-05 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700) Only available in English

ASTM F1314-01 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) Only available in English

ASTM F1341-99 Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications Only available in English

ASTM F1350-02 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) Only available in English

ASTM F1537-00 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) Only available in English

ASTM F1580-01 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants Only available in English

ASTM F1586-02 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium--10 Nickel--3 Manganese--2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) Only available in English

ASTM F562-02 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) Only available in English

ASTM F603-00 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application Only available in English

ASTM F620-00 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants Only available in English ASTM F621-02 Standard Specification for Stainless Steel Forgings for Surgical Implants Only available in English

ASTM F67-00 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) Only available in English

ASTM F688-05 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) Only available in English

ASTM F745-00 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications Only available in English

ASTM F75-01 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) Only available in English

ASTM F799-02 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) Only available in English

ASTM F899-02 Standard Specification for Stainless Steel for Surgical Instruments Only available in English ASTM F90-01 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) Only available in English

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

ISO 3826-1:2003 (2003-11-15) 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 5832-2:1999 Implants for surgery -- Metallic materials -- Part 2: Unalloyed titanium Only available in English

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 5832-5:1993 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 5832-9:1992 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 5832-12:1996 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy ISO 5834-2:1998 Implants for surgery -- Ultra-high molecular weight polyethylene -- Part 2: Moulded forms

ISO 6474:1994 Implants for surgery -- Ceramic materials based on high purity alumina

ISO 7153-1:1991 Surgical instruments -- Metallic materials -- Part 1: Stainless steel ISO 7153-1:1991/Amd 1:1999

CAN/CSA-Z900.1-03: 2003-01-01 Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements

Ophthalmology

ANSI Z80.7-2002
Ophthalmic Optics - Intraocular Lenses
Only available in English

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 11979-2:1999 Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods ISO 11979-2:1999/Cor 1:2003

ISO 11979-3:1999 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods

ISO 11979-5:1999 Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility ISO 11979-7:2006 Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical Investigations Only available in English

ISO 11980:1997 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations

ISO 11980:1997/Cor 1:1998 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

Orthopaedics

ASTM F1089-02 Standard Test Method for Corrosion of Surgical Instruments Only available in English

ASTM F1609-03 Standard Specification for Calcium Phosphate Coatings for Implantable Materials Only available in English

ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model Only available in English

ASTM F1800-04 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements Only available in English

ASTM F897-02 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws Only available in English

ASTM F1044-05 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Only available in English

ASTM F1147-05 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Only available in English

ASTM F1160-05 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Only available in English

ASTM F1377-04 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Only available in English

ASTM F1612-95(2000) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion Only available in English

ASTM F1659-95 Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates Only available in English

ASTM F1798-97(2003) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Only available in English

ASTM F1801-97 (2004) Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials Only available in English

ASTM F746-04 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials Only available in English

ASTM F86-04 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Only available in English

ASTM F983-86(2005) Standard Practice for Permanent Marking of Orthopaedic Implant Components Only available in English

ISO 14630:2005 Non-active surgical implants -- General requirements

ISO 5838-1:1995 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: 2002 Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties of stemmed femoral components -Second Edition

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 9583:1993 Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants

Radiology

AIUM/NEMA UD 2-2004, Revision 3 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Only available in English

AIUM/NEMA UD 3-2004, Revision 2 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Only available in English

IEC 60601-1-3 - Ed. 1.0 : 1994-07-14 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

IEC 60601-2-7 - Ed. 2.0 : 1998-02-26 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators Only available in English

IEC 60601-2-28 - Ed. 1.0 : 1993-03-07 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC 60601-2-32 - Ed. 1.0 : 1994-03-04 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

IEC 60601-2-37 - Consol. Ed. 1.1 (incl. am1) : 2004-10-14 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment Only available in English

IEC 60601-2-43 - Ed. 1.0 : 2000-06-30 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures Only available in English

IEC 60601-2-44 - Consol. Ed. 2.1 (incl. am1) : 2002-11-15 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography Only available in English

Sterilization

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

CSA 11134-98 (R2003) Sterilization of Health Care Products - Requirements for Validation and Routine Control -- Industrial Moist Heat Sterilization Only available in English

ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization ISO 11135:1994/Cor 1:1994 (only available in English)

CSA 11135-98 (R2003) Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization

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 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

ISO 11138-1:1994 Sterilization of health care products -- Biological indicators -- Part 1: General

ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization

ISO 11138-3:1995 Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization

ISO 11737-1:1995 Sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products

ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packages Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization