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LISTADO NORMAS ISO

ISO 1000 ISO 10002 ISO 10002 ISO 10005 ISO 10006 ISO 10007 ISO 10012 ISO 10015

SI Units and Recommendations for the Use of Their Multiples and of Certain Other Units-Third Edition; Amendment 1: 11-01-1998 Quality management Customer satisfaction Guidelines for complaints handling in organizations-First Edition Quality management Customer satisfaction Guidelines for complaints handling in organizations-First Edition Quality Management Systems - Guidelines for Quality Plans-Second Edition Quality management systems Guidelines for quality management in projects-Second Edition Quality management systems Guidelines for configuration management-Second Edition Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment-First Edition Quality Management - Guidelines for Training-First Edition

ISO 10079Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment - Safety Requirements-Second Edition 1 ISO 10083 Oxygen Concentrators for Use with Medical Gas Pipeline Systems First Edition

ISO 10110- Optics and Optical Instruments - Preparation of Drawings for Optical Elements and Systems - Part 5: Surface Form Tolerances-First Edition; 5 Corrigendum 1: 1996 ISO 10271 ISO 10334 ISO 10340 ISO 10477 ISO 10535 Dental Metallic Materials - Corrosion Test Methods-First Edition; Corrigendum 1: 1/15/2005 Implants for Surgery - Malleable Wires for Use as Sutures and Other Surgical Applications First Edition Optics and Optical Instruments - Contact Lenses - Method for Determining the Extractable Substances First Edition Dentistry - Polymer-Based Crown and Bridge Materials-Second Edition Hoists for the Transfer of Disabled Persons - Requirements and Test Methods-First Edition

ISO 10555- Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements-First Edition; CEN EN ISO 10 555-1: 1996; Amendment 1: 7/15/99; 1 Amendment 2: 05/15/2004 ISO 10555Sterile, Single-Use Intravascular Catheters - Part 2: Angiographic Catheters-First Edition; Technical Corrigendum 1: 6/15/2002 2 ISO 10555Sterile, Single-Use Intravascular Catheters - Part 3: Central Venous Catheters-First Edition; Corrigendum 1: 6/15/2002 3 ISO 10555Sterile, Single-Use Intravascular Catheters - Part 4: Balloon Dilatation Catheters-First Edition; Corrigendum 1: 6/15/2002 4 ISO 10555- Sterile, Single-Use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters-First Edition; Amendment 1: 01/15/1999; Corrected and 5 Reprinted 07/15/1999: Corrigendum 1: 6/15/2002 ISO 10650- Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps-First Edition; Together with ISO 10650-2 Replaces ISO TS 1 10650:1999 ISO 10651Lung Ventilators- - Part 4: Particular Requirements for Operator-Powered Resuscitators-First Edition 4 ISO 10993Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing- Third Edition 1 ISO 10993Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity-Second Edition 10 ISO 10993Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity First Edition; (CEN EN ISO 10993-11: 1995) 11 ISO 10993Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials-Second Edition; Corrected Version 06/01/2003 12 ISO 10993- Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices-First 13 Edition ISO 10993- Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys-First Edition; 15 Corrected and Reprinted: 4/01/2001 ISO 10993Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables-First Edition 16 ISO 10993Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances-First Edition 17 ISO 10993Biological evaluation of medical devices Part 18: Chemical characterization of materials-First Edition 18 ISO 10993Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements First Edition 2

ISO 10993Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-Second Edition 3 ISO 10993Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood-Second Edition 4 ISO 10993Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity-Second Edition 5 ISO 10993Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation First Edition; (CEN EN 30993-6: 1994) 6 ISO 10993Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals First Edition; (CEN EN ISO 10993-7: 1995) 7 ISO 10993Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products-First Edition 9 ISO 11040Prefilled Syringes - Part 4: Glass Barrels for Injectables First Edition 4 ISO 11040Prefilled Syringes - Part 5: Plungers for Injectables-Second Edition 5 ISO 11070 ISO 11134 ISO 11135 ISO 11137 Sterile Single-Use Intravascular Catheter Introducers-First Edition Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization First Edition Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization-First Edition; Corrigendum 1: 1994 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization-First Edition; Technical Corrigendum 1-1997; Amendment 1:12/15/2001

ISO 11138Sterilization of Health Care Products - Biological Indicators - Part 1: General First Edition 1 ISO 11138Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization First Edition 2 ISO 11138Sterilization of Health Care Products - Biological Indicators - Part 3: Biological Indicators for Moist Heat Sterilization-First Edition 3 ISO 11140Sterilization of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicators for Steam Penetration Test Sheets-First Edition 3 ISO 11145 Optics and Optical Instruments - Lasers and Laser-Related Equipment - Vocabulary and Symbols-Second Edition

ISO 11193- Single-use medical examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution-First Edition; Supersedes ISO 1 11193: 1994; Corrigendum 1: 06/15/2005 ISO 11318 Cardiac Defibrillators - Connector Assembly DF-1 for Implantable Defibrillators - Dimensional and Test Requirements-Second Edition

ISO 1135- 3 Transfusion Equipment for Medical Use - Part 3: Blood-Taking Set-First Edition ISO 1135- 4 Transfusion equipment for medical use Part 4: Transfusion sets for single use-Third Edition ISO 11607 Packaging for terminally sterilized medical devices-Second Edition

ISO 11608Pen-Injectors for Medical Use - Part 1: Pen-Injectors - Requirements and Test Methods-First Edition 1 ISO 11737Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of Population of Microorganisms on Products-First Edition 1 ISO 11737- Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process-First 2 Edition ISO 11737Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data-First Edition 3 ISO 11948Urine-Absorbing Aids - Part 1: Whole-Product Testing First Edition 1 ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 1: Vocabulary-First Edition 1 ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 2:Optical Properties and Test Methods-First Edition; Corrigendum 1: 11/1/2003 2 ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods-First Edition 3 ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility-First Edition 5 ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 6: Shelf-Life and Transport Stability-First Edition 6 ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations- First Edition 7

ISO 11979Ophthalmic Implants - Intraocular Lenses - Part 8: Fundamental Requirements-First Edition; Technical Corrigendum 1 11-15-2003 8 ISO 11981 ISO 11987 ISO 11990 ISO 12119 ISO 12207 ISO 12864 ISO 12870 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses-First Edition Opthalmic Optics - Contact Lenses - Determination of Self-Life-First Edition Optics and Optical Instruments - Lasers and Laser-Related Equipment - Determination of Laser Resistance of Tracheal Tube Shafts-Second Edition Information Technology - Software Packages - Quality Requirements and Testing-First Edition; AS/NZS 4366: 1996 Information Technology - Software Life Cycle Processes-First Edition; Amendment 1: 5/01/2002; Amendment 2: 11/01/2004 Opthalmic Optics - Contact lenses - Determination of Scattered Light-First Edition Ophthalmic optics Spectacle frames Requirements and test methods-Second Edition; Replaces ISO 9456:1991

ISO 12891Retrieval and Analysis of Surgical Implants - Part 1: Retrieval and Handling-First Edition 1 ISO 12891Retrieval and Analysis of Surgical Implants - Part 2: Analysis of Retrieved Metallic Surgical Implants-First Edition 2 ISO 12891Retrieval and Analysis of Surgical Implants - Part 3: Analysis of Retrieved Polymeric Surgical Implants-First Edition 3 ISO 13294 ISO 13295 Dental Handpieces - Dental Air-Motors-First Edition Dental Rotary Instruments - Mandrels First Edition

ISO 13397Periodontal Curettes, Dental Scalers and Excavators - Part 4: Dental Excavators - Discoid Type-First Edition 4 ISO 13402 Surgical and Dental Hand Instruments - Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure-First Edition

ISO 13405Prosthetics and Orthotics - Classification and Description of Prosthetic Components - Part 1: Classification of Prosthetic Components First Edition 1 ISO 13405- Prosthetics and Orthotics - Classification and Description of Prosthetic Components - Part 2: Description of Lower-Limb Prosthetic Components First 2 Edition ISO 13405- Prosthetics and Orthotics - Classification and Description of Prosthetic Components - Part 3: Description of Upper-Limb Prosthetic Components First 3 Edition ISO 13408Aseptic Processing of Health Care Products - Part 1: General Requirements-First Edition 1 ISO 13408Aseptic Processing of Health Care Products - Part 2: Filtration-First Edition 2 ISO 13408Aseptic processing of health care products Part 4: Clean-in-place technologies-First Edition 4 ISO 13408Aseptic processing of health care products Part 6: Isolator systems-First Edition 6 ISO 13485 ISO 13488 ISO 13683 Medical devices Quality management systems Requirements for regulatory purposes-Second Edition Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9002-First Edition Sterilization of Health Care Products - Requirements for Validation and Routine Control of Moist Heat Sterilization in Health Care Facilities-First Edition

ISO 13779Implants for Surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite- First Edition 1 ISO 13779Implants for Surgery - Hydroxyapatite - Part 2: Coatings of Hydroxyapatite- First Edition 2 ISO 13779Implants for Surgery - Hydroxyapatite - Part 4: Determination of Coating Adhesion Strength-First Edition 4 ISO 13781 ISO 13782 ISO 13852 ISO 14001 ISO 14004 Poly(L-lactide) Resins and Fabricated Forms for Surgical Implants - In Vitro Degradation Testing-First Edition Implants for Surgery - Metallic Materials - Unalloyed Tantalum for Surgical Implant Applications-First Edition Safety of Machinery - Safety Distances to Prevent Danger Zones Being Reached by the Upper Limbs-First Edition Environmental management systems Requirements with guidance for use-Second Edition Environmental Management Systems - General Guidelines on Principles, Systems and Supporting Techniques-Second Edition

ISO 14155- Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans-First Edition; Together with the first edition of 2 14155-1 Cancels and Replaces 14155: 1996 ISO 14160 ISO 14161 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Sterilants-First Edition Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results-First Edition

ISO 14242- 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-First Edition

ISO 14242Implants for Surgery - Wear of Total Hip-Joint Prostheses - Part 2: Methods of Measurement-First Edition 2 ISO 14243- Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement 3 control and corresponding environmental conditions for test-First Edition ISO 14534 ISO 14602 ISO 14630 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Fundamental Requirements-Second Edition Non-Active Surgical Implants - Implants for Osteosynthesis - Particular Requirements-First Edition Non-active surgical implants - General requirements-Second Edition

ISO 14644Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness-First Edition 1 ISO 14644- Cleanrooms and Associated Controlled Environments - Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 2 14644-1- First Edition ISO 14644Cleanrooms and Associated Controlled Environments - Part 4: Design, Construction and Start-Up-First Edition 4 ISO 14644Cleanrooms and associated controlled environments Part 5: Operations- First Edition 5 ISO 14698Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods-First Edition 1 ISO 14698- Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data-First 2 Edition; TECHNICAL CORRIGENDUM 1: 11/1/2004 ISO 14708- Implants for Surgery - Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and for Information to be Provided by 1 the Manufacturer-First Edition ISO 14730 ISO 14801 ISO 14937 ISO 14949 ISO 14971 ISO 15004 ISO 15026 ISO 15189 ISO 15190 ISO 15193 ISO 15194 ISO 15195 ISO 15197 ISO 15198 ISO 15223 ISO 15225 ISO 15394 ISO 15417 Ophthalmic Optics - Contact Lens Care Products - Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard Date-First Edition Dentistry Fatigue test for endosseous dental implants-First Edition 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-First Edition; Technical Corrigendum 1: 6/01/200 Implants for Surgery - Two-Part Addition-Cure Silicone Elastomers- First Edition Medical Devices - Application of Risk Management to Medical Devices-First Edition; Amendment 1: 3/01/2003 Opthalmic Instruments - Fundamental Requirements and Test Methods-First Edition Information Technology - System and Software Integrity Levels-First Edition Medical laboratories Particular requirements for quality and competence-First Edition; Corrected Version 07/15/2003 Medical laboratories Requirements for safety-First Edition In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Presentation of Reference Measurement Procedures-First Edition In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials-First Edition Laboratory medicine Requirements for reference measurement laboratories-First Edition In Vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus-First Edition Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer-First Edition Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-First Edition: Amendment 1: 8/01/2002; Amendment 2: 02/15/2004 Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange-First Edition; Amendment 1: 02/01/2004 Packaging - Bar Code and Two-Dimensional Symbols for Shipping, Transport and Receiving Labels-First Edition Information Technology - Automatic Identification and Data Capture Techniques - Bar Code Symbology Specification - Code 128-First Editon

ISO 15489Information and Documentation - Records Management - Part 1: General- First Edition 1 ISO 1562 ISO 15675 ISO 15747 ISO 15798 ISO 15814 ISO 15882 ISO 16054 Dentistry Casting gold alloys-Fourth Edition Cardiovascular Implants and Artificial Organs - Cardiopulmonary Bypass Systems - Arterial Line Blood Filters-First Edition Plastics containers for intravenous injection-First Edition Ophthalmic Implants - Ophthalmic Viscosurgical Devices-First Edition; Technical Corrigendum 1: 11/1/03 Implants for Surgery - Copolymers and Blends Based on Polylactide - In Vitro Degradation Testing-First Edition Sterilization of Health Care Products - Chemical Indicators - Guidance for Selection, Use and Interpretation of Results-First Edition Implants for Surgery - Minimum Data Sets for Surgical Implants-First Edition

ISO 16061

Instrumentation for Use in Association with Non-Active Surgical Implants - General Requirements-First Edition

ISO 16269Statistical interpretation of data Part 8: Determination of prediction intervals-First Edition 8 ISO 16672 ISO 17025 ISO 17511 ISO 17664 ISO 18153 ISO 19011 ISO 1942- 1 ISO 21535 Ophthalmic Implants - Ocular Endotamponades-First Edition General requirements for the competence of testing and calibration laboratories-Second edition In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials-First edition Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices-First Edition In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological aceability of values for catalytic concentration of enzymes assigned to calibrators and control materials-First Edition Guidelines for Quality and/or Environmental Management Systems Auditing-First Edition; Replaces ISO 10011-1:1990, ISO 10011-2:1991, ISO 10011-3:1991, ISO 14010:1996, ISO 14011:1996, and ISO 14012:1996 Dental Vocabulary - Part 1: General and Clinical Terms-Second Edition; Amendment 1-1992; Amendment 2-1992; Amendment 3-1993; Amendment 5-1993; PNS 1248-1: 1994 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants-First Edition

ISO 25539- Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses AMENDMENT 1: Test methods-First Edition; Amendment 1: 1 07/15/2005 ISO 2859- 0 Sampling Procedures for Inspection by Attributes - Part 0: Introduction to the ISO 2859 Attribute Sampling System-First Edition ISO 2859- 1 ISO 2919 Sampling Procedures for Inspection by Attributes - Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot InspectionSecond Edition; Corrigendum 1: 03-01-2001 Radioactive Protection - Sealed Radioactive Sources - General Requirements and Classification-Second Edition; Cancels and Replaces ISO 1677: 1977

ISO 3166- 1 Codes for the Representation of Names of Countries and Their Subdivisions - Part 1: Country Codes-Fifth Edition; Replaces ISO 3166 ISO 32 Gas Cylinders for Medical Use - Marking for Identification of Content-First Edition; Erratum-1979

ISO 3534- 1 Statistics - Vocabulary and Symbols - Part 1: Probability and General Statistical Terms First Edition; (ASQC A3534-1: 1993) ISO 3534- 2 Statistics - Vocabulary and Symbols - Part 2: Statistical Quality Control First Edition; (ASQC A3534-2: 1993) ISO 361 Basic Ionizing Radiation Symbol-First Edition

ISO 3630- 2 Dental Root Canal Instruments - Part 2: Enlargers-Second Edition ISO 3696 ISO 37 ISO 3744 Water for Analytical Laboratory Use - Specification and Test Methods- First Edition Rubber, vulcanized or thermoplastic - Determination of tensile stress- strain properties-Fourth Edition Acoustics - Determination of Sound Power Levels of Noise Sources Using Sound Pressure - Engineering Method in an Essentially Free Field over a Reflecting Plane Second Edition; (CEN EN ISO 3744: 1995)

ISO 3823- 1 Dental Rotary Instruments - Burs - Part 1: Steel and Carbide Burs- Second Edition ISO 3826- 1 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers-First Edition; Replaces ISO 3826 ISO 3864- 2 Graphical symbols Safety colours and safety signs Part 2: Design principles for product safety labels-First Edition ISO 4049 ISO 407 ISO 4074 ISO 4135 Dentistry - Polymer-Based Filling, Restorative and Luting Materials- Third Edition Small Medical Gas Cylinders - Pin-Index Yoke-Type Valve Connections- Third Edition Natural Latex Rubber Condoms - Requirements and Test Methods- First Edition; Cancels and Replaces ISO 4074 Parts 1-10; Technical Corrigendum 1: 11/01/2003 Anaesthetic and Respiratory Equipment - Vocabulary-Third Edition

ISO 5356- 1 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets-Third Edition ISO 5359 ISO 5361 ISO 5362 ISO 5364 ISO 5367 Low-Pressure Hose Assemblies for Use with Medical Gases-Second Edition Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors-First Edition; Cancels and Replaces ISO 5361-1: 1988, ISO 5361-2: 1993, ISO 5361-3: 1984, ISO 5361-5: 1984 and ISO 7228: 1993; Corrected and Reprinted 12/15/1999 Anaesthetic Reservoir Bags-Third Edition Anaesthetic and Respiratory Equipment - Oropharyngeal Airways- Third Edition Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators-Fourth Edition

ISO 5636- 5 Paper and board Determination of air permeance and air resistance (medium range) Part 5: Gurley method-Second Edition ISO 5725- 1 ISO 5725- 2 ISO 5725- 5 Accuracy (Trueness and Precision) of Measurement Methods and Results - Part 1: General Principles and Definitions-First Edition; Corrigendum 11998 Accuracy (Trueness and Precision) of Measurement Methods and Results - Part 2: Basic Method for the Determination of Repeatability and Reproducibility of a Standard Measurement Method First Edition;-Technical Corrigendum 1: 5/15/2002 Accuracy (Trueness and Precision) of Measurement Methods and Results - Part 5: Alternative Methods for the Determination of the Precision of a Standard Measurement Method-First Edition; Corrigendum 1: 8/15/2005

ISO 5832- 1 Implants for Surgery - Metallic Materials - Part 1: Wrought Stainless Steel- Third Edition ISO 5832- 2 Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium-Third Edition ISO 5832- 3 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6- Aluminium 4-Vanadium Alloy Third Edition; (CAN/CSA-Z310.8-M91) ISO 5832- 4 Implants for Surgery - Metallic Materials - Part 4: Cobalt- Chromium- Molybdenum Casting Alloy Second Edition; (CAN/CSA-Z310.9-M91) ISO 5832- 7 Implants for Surgery - Metallic Materials - Part 7: Forgeable and Cold- Formed Cobalt- Chromium-Nickel- Molybdenum-Iron Alloy Second Edition ISO 5832- 9 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel First Edition ISO 5833 Implants for Surgery - Acrylic Resin Cements-Second Edition

ISO 5834- 1 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form-Third edition ISO 5834- 2 Implants for Surgery - Ultra-High Molecular Weight Polyethylene - Part 2: Moulded Forms-Second Edition ISO 5834- 3 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods-First Edition ISO 5835 ISO 5840 Implants for Surgery - Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Asymmetrical Thread - Dimensions First Edition Cardiovascular Implants - Cardiac Valve Prostheses-Fourth Edition

ISO 5841- 1 Cardiac Pacemakers - Part 1: Implantable Pacemakers Second Edition ISO 5841- 2 Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads-Second Edition ISO 5841- 3 ISO 594- 1 ISO 594- 2 ISO 595- 1 ISO 6009 ISO 6710 ISO 6872 ISO 7000 Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers-Second Edition; TECHNICAL CORRIGENDUM 1: 11/15/2003 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements-First Edition; CEN EN 20594-1: 1993 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings-Second Edition Reusable All-Glass or Metal-and-Glass Syringes for Medical Use - Part 1: Dimensions-First Edition; Corrected and Reprinted - 1988 Hypodermic Needles for Single Use - Colour Coding for Identification Third Edition; (CEN EN ISO 6009: 1994) Single-Use Containers for Venous Blood Specimen Collection First Edition; (Corrected and Reprinted - 1996) Dental Ceramic-Second Edition; Amendment 1-1997,Corrected and Reprinted 06/15/1998 Graphical symbols for use on equipment Index and synopsis-Third Edition

ISO 7176- 2 Wheelchairs - Part 2: Determination of Dynamic Stability of Electric Wheelchairs-Second Edition ISO 7176- 3 Wheelchairs - Part 3: Determination of Effectiveness of Brakes-Second Edition ISO 7176- 5 Wheelchairs - Part 5: Determination of Overall Dimensions, Mass and Turning Space First Edition ISO 7197 ISO 7198 ISO 7199 Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components-Second Edition Cardiovascular Implants - Tubular Vascular Prostheses-First Edition Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)-First Edition

ISO 7206- 1 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 1: Classification and Designation of Dimensions Second Edition ISO 7206- 2 ISO 7206- 4 ISO 7206- 6 ISO 7206- 8 ISO 7396 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 2: Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials Second Edition; (CAN/CSA-Z310.14-M92) Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties of stemmed femoral components-Second Edition Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components First Edition Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion First Edition Non-Flammable Medical Gas Pipeline Systems First Edition

ISO 7396- 1 Medical Gas Pipeline Systems - Part 1: Pipelines for Compressed Medical Gases and Vacuum-First Edition ISO 7405 ISO 7741 ISO 7864 Dentistry - Preclinical Evaluation of Biocompatability of Medical Devices Used in Dentistry - Test Methods for Dental Materials-First Edition; Replaces ISO TR 7405 Instruments for Surgery - Scissors and Shears - General Requirements and Test Methods First Edition Sterile Hypodermic Needles for Single Use Third Edition; (CEN EN ISO 7864: 1995)

ISO 7886- 1 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use-First Edition; Replaces ISO 7886; Corrigendum 1-1995 ISO 8009 ISO 8185 ISO 8318 Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and tests-First Edition; Replaces ISO 8009-1, ISO 8009-2, ISO 8009-3, ISO 8009-4, ISO 8009-5, ISO 8009-6, ISO 8009-7, ISO 8009-8, ISO 8009-9 and ISO Humidifiers for Medical Use - General Requirements for Humidification Systems-Second Edition; Technical Corrigendum 1: 5/15/2001 Packaging - Complete, Filled Transport Packages and Unit Laods - Sinusoidal Vibration Tests Using a Variable Frequency-Second Edition

ISO 8319- 1 Orthopaedic Instruments - Drive Connections - Part 1: Keys for Use with Screws with Hexagon Socket Heads Second Edition; (CAN/CSA-Z310.16-

M91) ISO 8320- 1 Contact lenses and contact lens care products Vocabulary Part 1: Contact lenses-First Edition; Replaces ISO 8320 ISO 8321- 1 ISO 8321- 2 ISO 8359 Ophthalmic Optics - Specifications for Material, Optical and Dimensional Properties of Contact Lenses - Part 1: Rigid Corneal and Scleral Contact Lenses-Second Edition Ophthalmic Optics - Specifications for Material, Optical and Dimensional Properties of Contact Lenses - Part 2: Single-Vision Hydrogel Contact Lenses-Second Edition Oxygen Concentrators for Medical Use - Safety Requirements- Second Edition

ISO 8362- 2 Injection Containers for Injectables and Accessories - Part 2: Closures for Injection Vials First Edition; (CEN EN 28362-2: 1993) ISO 8382 ISO 853610 ISO 853611 Resuscitators Intended for Use with Humans First Edition Infusion equipment for medical use Part 10: Accessories for fluid lines for use with pressure infusion equipment-First Edition Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipment-First Edition

ISO 8536- 4 Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use, Gravity Feed-Third Edition ISO 8536- 5 Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity feed-Second Edition ISO 8536- 9 Infusion equipment for medical use Part 9: Fluid lines for use with pressure infusion equipment-First Edition ISO 8537 Sterile Single-Use Syringes, with or without Needle, for Insulin-First Edition; Amendment 1: 11/01/2000

ISO 8549- 1 Prosthetics and Orthotics - Vocabulary - Part 1: General Terms for External Limb Prostheses and External Orthoses First Edition ISO 8600- 3 ISO 8600- 4 ISO 8601 ISO 8827 ISO 8836 ISO 8871- 3 ISO 9000 ISO 90003 ISO 9001 ISO 9004 Optics and optical instruments Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics-First Edition; AMENDMENT 1: 12/01/2003 Optics and Optical Instruments - Medical Endoscopes and Certain Accessories - Part 4: Determination of Maximum Width of Insertion Portion-First Edition Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times-Third Edition Implants for Surgery - Staples with Parallel Legs for Orthopaedic Use - General Requirements First Edition Suction Catheters for Use in the Respiratory Tract-Second Edition Elastomeric parts for parenterals and for devices for pharmaceutical use Part 3: Determination of released-particle count-First Edition; 8871-1 thru 8871-5 Cancels and Replaces 8871 Quality Management Systems - Fundamentals and Vocabulary-Third Edition Software engineering Guidelines for the application of ISO 9001:2000 to computer software-First Edition; Quality Management Systems - Requirements-Third Edition; Supersedes ISO 9002:1994 and ISO 9003:1994 Quality Management Systems - Guidelines for Performance Improvements-Second Edition; Supersedes ISO 9004-1:1994

ISO 9126- 1 Software Engineering - Product Quality - Part 1: Quality Model-First Edition; Cancels and Replaces ISO/IEC 9126:1991 ISO 9170- 1 Terminal Units for Medical Gas Pipeline Systems - Part 1: Terminal Units for Use with Compressed Medical Gases and Vacuum-First Edition ISO 9333 ISO 9339- 2 ISO 9360- 1 ISO 9585 ISO 9626 ISO 9687 Dental Brazing Materials First Edition; (CAN/CSA-Z349.45-93) Optics and Optical Instruments - Contact Lenses - Determination of Thickness - Part 2: Hydrogel Contact Lenses-First Edition; Corrigendum 1: 04/15/2000 Anaesthetic and Respiratory Equipment - Heat and Moisture Exchangers (HMEs) for Humidifying Respired Gases in Humans - Part 1: HMEs for Use with Minimum Tidal Volumes of 250 ml-First Edition Implants for Surgery - Determination of Bending Strength and Stiffness of Bone Plates First Edition Stainless Steel Needle Tubing for Manufacture of Medical Devices- Amendment 1:06/01/2001 Dental Equipment - Graphical Symbols First Edition; (CEN EN ISO 9687: 1995)

ISO 9714- 1 Orthopaedic Drilling Instruments - Part 1: Drill Bits, Taps and Countersink Cutters First Edition ISO 9919 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical useSecond edition

ISO GUIDE Safety Aspects - Guidelines for Their Inclusion in Standards-Second Edition 51 ISO GUIDE Guide to the Development and Inclusion of Safety Aspects in International Standards for Medical Devices-First Edition 63 ISO TR 10013 ISO TR 10017 ISO TR 13425 Guidelines for Quality Management System Documentation-First Edition Guidance on statistical techniques for ISO 9001:2000-Second Edition Guidelines for the selection of statistical methods in standardization and specification-Second Edition

ISO TR 13570- 1 ISO TR 14283 ISO TR 14969 ISO TR 15300 ISO TR 15489- 2 ISO TR 15844 ISO TR 16142 ISO TR 8550 ISO TS 11139 ISO TS 11405 ISO TS 13409 ISO TS 15539 ISO TS 15843 ISO TS 20225 ISO TS 21748

Wheelchairs Part 1: Guidelines for the application of the ISO 7176 series on wheelchairs-First Edition: Replaces ISO TR 13570:2001 Implants for surgery Fundamental principles-Second Edition Medical devices Quality management systems Guidance on the application of ISO 13485:2003-First Edition; Replaces ISO 14969:1999 Dentistry - Application of OSI Clinical Codification to the Classification and Coding of Dental Products-First Editon Information and Documentation - Records Management - Part 2: Guidelines-First Edition Sterilization of Health Care Products - Radiation Sterilization - Selection of Sterilization Dose for a Single Production Batch-First Edition Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devicesSecond Edition Guide for the Selection of an Acceptance Sampling System, Scheme or Plan for Inspection of Discrete Items in Lots-First Edition Sterilization of Health Care Products - Vocabulary-Second Edition Dental Materials - Testing of Adhesion to Tooth Structure-Second Edition Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batchesFirst Edition; Replaces ISO 13409 Cardiovascular Implants - Endovascular Prostheses-First Edition Sterilization of Health Care Products - Radiation Sterilization - Product Families and Sampling Plans for Verification Dose Experiments and Sterilization Dose Audits, and Frequency of Sterilization Dose Audits-First Edition Global Medical Device Nomenclature for the Purpose of Regulatory Data Exchange-First Edition Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation-First Edition