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Medical Device Standards Library - ISO Collection

Description:
The Medical Device Standards Library - ISO Collection contains more than 275 documents. On June 14, 1998, the European Union Medical Devices Directive became mandatory for all manufacturers selling medical devices in the European marketplace. The Medical Devices Directive is concerned with all medical devices, from sterile Gants to electronic monitoring equipment and complex MRI-scanners. Companies manufacturing Class I Sterile, Class I Measuring, IIa, IIb or Class III devices that fall within the scope of the Medical Devices Directive must meet the essential requirements of that law.

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Popular Standards from this Collection.

ISO 1000

SI Units and Recommendations for the Use of Their Multiples and of Certain Other Units-Third Edition; Amendment 1: 11-01-1998

ISO 10002

Quality management Customer satisfaction Guidelines for complaints handling in organizations-First Edition

ISO 10002

Quality management Customer satisfaction Guidelines for complaints handling in organizations-First Edition

ISO 10005

Quality Management Systems - Guidelines for Quality Plans-Second Edition

ISO 10006

Quality management systems Guidelines for quality management in projects-Second Edition

ISO 10007

Quality management systems Guidelines for configuration management-Second Edition

ISO 10012

Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment-First Edition

ISO 10015

Quality Management - Guidelines for Training-First Edition

ISO 10079- 1

Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment - Safety Requirements-Second Edition

ISO 10083

Oxygen Concentrators for Use with Medical Gas Pipeline Systems First Edition

ISO 10110- 5

Optics and Optical Instruments - Preparation of Drawings for Optical Elements and Systems - Part 5: Surface Form Tolerances-First Edition; Corrigendum 1: 1996

ISO 10271

Dental Metallic Materials - Corrosion Test Methods-First Edition; Corrigendum 1: 1/15/2005

ISO 10334

Implants for Surgery - Malleable Wires for Use as Sutures and Other Surgical Applications First Edition

ISO 10340

Optics and Optical Instruments - Contact Lenses - Method for Determining the Extractable Substances First Edition

ISO 10477

Dentistry - Polymer-Based Crown and Bridge Materials-Second Edition

ISO 10535

Hoists for the Transfer of Disabled Persons - Requirements and Test Methods-First Edition

ISO 10555- 1

Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements-First Edition; CEN EN ISO 10 555-1: 1996; Amendment 1: 7/15/99; Amendment 2: 05/15/2004

ISO 10555- 2

Sterile, Single-Use Intravascular Catheters - Part 2: Angiographic Catheters-First Edition; Technical Corrigendum 1: 6/15/2002

ISO 10555- 3

Sterile, Single-Use Intravascular Catheters - Part 3: Central Venous Catheters-First Edition; Corrigendum 1: 6/15/2002

ISO 10555- 4

Sterile, Single-Use Intravascular Catheters - Part 4: Balloon Dilatation Catheters-First Edition; Corrigendum 1: 6/15/2002

ISO 10555- 5

Sterile, Single-Use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters-First Edition; Amendment 1: 01/15/1999; Corrected and Reprinted 07/15/1999: Corrigendum 1: 6/15/2002

ISO 10650- 1

Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps-First Edition; Together with ISO 10650-2 Replaces ISO TS 10650:1999

ISO 10651- 4

Lung Ventilators- - Part 4: Particular Requirements for Operator-Powered Resuscitators-First Edition

ISO 10993- 1

Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing- Third Edition

ISO 10993- 10

Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity-Second Edition

ISO 10993- 11

Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity First Edition; (CEN EN ISO 10993-11: 1995)

ISO 10993- 12

Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials-Second Edition; Corrected Version 06/01/2003

ISO 10993- 13

Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices-First Edition

ISO 10993- 15

Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys-First Edition; Corrected and Reprinted: 4/01/2001

ISO 10993- 16

Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables-First Edition

ISO 10993- 17

Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances-First Edition

ISO 10993- 18

Biological evaluation of medical devices Part 18: Chemical characterization of materials-First Edition

ISO 10993- 2

Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements First Edition

ISO 10993- 3

Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-Second Edition

ISO 10993- 4

Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood-Second Edition

ISO 10993- 5

Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity-Second Edition

ISO 10993- 6

Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation First Edition; (CEN EN 30993-6: 1994)

ISO 10993- 7

Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals First Edition; (CEN EN ISO 10993-7: 1995)

ISO 10993- 9

Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products-First Edition

ISO 11040- 4

Prefilled Syringes - Part 4: Glass Barrels for Injectables First Edition

ISO 11040- 5

Prefilled Syringes - Part 5: Plungers for Injectables-Second Edition

ISO 11070

Sterile Single-Use Intravascular Catheter Introducers-First Edition

ISO 11134

Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization First Edition

ISO 11135

Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization-First Edition; Corrigendum 1: 1994

ISO 11137

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 11138- 1

Sterilization of Health Care Products - Biological Indicators - Part 1: General First Edition

ISO 11138- 2

Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization First Edition

ISO 11138- 3

Sterilization of Health Care Products - Biological Indicators - Part 3: Biological Indicators for Moist Heat Sterilization-First Edition

ISO 11140- 3

Sterilization of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicators for Steam Penetration Test Sheets-First Edition

ISO 11145

Optics and Optical Instruments - Lasers and Laser-Related Equipment - Vocabulary and Symbols-Second Edition

ISO 11193- 1

Single-use medical examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution-First Edition; Supersedes ISO 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 11608- 1

Pen-Injectors for Medical Use - Part 1: Pen-Injectors - Requirements and Test Methods-First Edition

ISO 11737- 1

Sterilization of Medical Devices - Microbiological Methods - Part 1: Estimation of Population of Microorganisms on Products-First Edition

ISO 11737- 2

Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process-First Edition

ISO 11737- 3

Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data-First Edition

ISO 11948- 1

Urine-Absorbing Aids - Part 1: Whole-Product Testing First Edition

ISO 11979- 1

Ophthalmic Implants - Intraocular Lenses - Part 1: Vocabulary-First Edition

ISO 11979- 2

Ophthalmic Implants - Intraocular Lenses - Part 2:Optical Properties and Test Methods-First Edition; Corrigendum 1: 11/1/2003

ISO 11979- 3

Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods-First Edition

ISO 11979- 5

Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility-First Edition

ISO 11979- 6

Ophthalmic Implants - Intraocular Lenses - Part 6: Shelf-Life and Transport Stability-First Edition

ISO 11979- 7

Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations- First Edition

ISO 11979- 8

Ophthalmic Implants - Intraocular Lenses - Part 8: Fundamental Requirements-First Edition; Technical Corrigendum 1 11-15-2003

ISO 11981

Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses-First Edition

ISO 11987

Opthalmic Optics - Contact Lenses - Determination of Self-Life-First Edition

ISO 11990

Optics and Optical Instruments - Lasers and Laser-Related Equipment - Determination of Laser Resistance of Tracheal Tube Shafts-Second Edition

ISO 12119

Information Technology - Software Packages - Quality Requirements and Testing-First Edition; AS/NZS 4366: 1996

ISO 12207

Information Technology - Software Life Cycle Processes-First Edition; Amendment 1: 5/01/2002; Amendment 2: 11/01/2004

ISO 12864

Opthalmic Optics - Contact lenses - Determination of Scattered Light-First Edition

ISO 12870

Ophthalmic optics Spectacle frames Requirements and test methods-Second Edition; Replaces ISO 9456:1991

ISO 12891- 1

Retrieval and Analysis of Surgical Implants - Part 1: Retrieval and Handling-First Edition

ISO 12891- 2

Retrieval and Analysis of Surgical Implants - Part 2: Analysis of Retrieved Metallic Surgical Implants-First Edition

ISO 12891- 3

Retrieval and Analysis of Surgical Implants - Part 3: Analysis of Retrieved Polymeric Surgical Implants-First Edition

ISO 13294

Dental Handpieces - Dental Air-Motors-First Edition

ISO 13295

Dental Rotary Instruments - Mandrels First Edition

ISO 13397- 4

Periodontal Curettes, Dental Scalers and Excavators - Part 4: Dental Excavators - Discoid Type-First Edition

ISO 13402

Surgical and Dental Hand Instruments - Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure-First Edition

ISO 13405- 1

Prosthetics and Orthotics - Classification and Description of Prosthetic Components - Part 1: Classification of Prosthetic Components First Edition

ISO 13405- 2

Prosthetics and Orthotics - Classification and Description of Prosthetic Components - Part 2: Description of Lower-Limb Prosthetic Components First Edition

ISO 13405- 3

Prosthetics and Orthotics - Classification and Description of Prosthetic Components - Part 3: Description of Upper-Limb Prosthetic Components First Edition

ISO 13408- 1

Aseptic Processing of Health Care Products - Part 1: General Requirements-First Edition

ISO 13408- 2

Aseptic Processing of Health Care Products - Part 2: Filtration-First Edition

ISO 13408- 4

Aseptic processing of health care products Part 4: Clean-in-place technologies-First Edition

ISO 13408- 6

Aseptic processing of health care products Part 6: Isolator systems-First Edition

ISO 13485

Medical devices Quality management systems Requirements for regulatory purposes-Second Edition

ISO 13488

Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9002-First Edition

ISO 13683

Sterilization of Health Care Products - Requirements for Validation and Routine Control of Moist Heat Sterilization in Health Care Facilities-First Edition

ISO 13779- 1

Implants for Surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite- First Edition

ISO 13779- 2

Implants for Surgery - Hydroxyapatite - Part 2: Coatings of Hydroxyapatite- First Edition

ISO 13779- 4

Implants for Surgery - Hydroxyapatite - Part 4: Determination of Coating Adhesion Strength-First Edition

ISO 13781

Poly(L-lactide) Resins and Fabricated Forms for Surgical Implants - In Vitro Degradation Testing-First Edition

ISO 13782

Implants for Surgery - Metallic Materials - Unalloyed Tantalum for Surgical Implant Applications-First Edition

ISO 13852

Safety of Machinery - Safety Distances to Prevent Danger Zones Being Reached by the Upper Limbs-First Edition

ISO 14001

Environmental management systems Requirements with guidance for use-Second Edition

ISO 14004

Environmental Management Systems - General Guidelines on Principles, Systems and Supporting Techniques-Second Edition

ISO 14155- 2

Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans-First Edition; Together with the first edition of 14155-1 Cancels and Replaces 14155: 1996

ISO 14160

Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Sterilants-First Edition

ISO 14161

Sterilization of Health Care Products - Biological Indicators - Guidance for the Selection, Use and Interpretation of Results-First Edition

ISO 14242- 1

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 14242- 2

Implants for Surgery - Wear of Total Hip-Joint Prostheses - Part 2: Methods of Measurement-First Edition

ISO 14243- 3

Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test-First Edition

ISO 14534

Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Fundamental Requirements-Second Edition

ISO 14602

Non-Active Surgical Implants - Implants for Osteosynthesis - Particular Requirements-First Edition

ISO 14630

Non-active surgical implants - General requirements-Second Edition

ISO 14644- 1

Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness-First Edition

ISO 14644- 2

Cleanrooms and Associated Controlled Environments - Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1- First Edition

ISO 14644- 4

Cleanrooms and Associated Controlled Environments - Part 4: Design, Construction and Start-Up-First Edition

ISO 14644- 5

Cleanrooms and associated controlled environments Part 5: Operations- First Edition

ISO 14698- 1

Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods-First Edition

ISO 14698- 2

Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data-First Edition; TECHNICAL CORRIGENDUM 1: 11/1/2004

ISO 14708- 1

Implants for Surgery - Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and for Information to be Provided by the Manufacturer-First Edition

ISO 14730

Ophthalmic Optics - Contact Lens Care Products - Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard Date-First Edition

ISO 14801

Dentistry Fatigue test for endosseous dental implants-First Edition

ISO 14937

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

ISO 14949

Implants for Surgery - Two-Part Addition-Cure Silicone Elastomers- First Edition

ISO 14971

Medical Devices - Application of Risk Management to Medical Devices-First Edition; Amendment 1: 3/01/2003

ISO 15004

Opthalmic Instruments - Fundamental Requirements and Test Methods-First Edition

ISO 15026

Information Technology - System and Software Integrity Levels-First Edition

ISO 15189

Medical laboratories Particular requirements for quality and competence-First Edition; Corrected Version 07/15/2003

ISO 15190

Medical laboratories Requirements for safety-First Edition

ISO 15193

In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Presentation of Reference Measurement Procedures-First Edition

ISO 15194

In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials-First Edition

ISO 15195

Laboratory medicine Requirements for reference measurement laboratories-First Edition

ISO 15197

In Vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus-First Edition

ISO 15198

Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer-First Edition

ISO 15223

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

ISO 15225

Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange-First Edition; Amendment 1: 02/01/2004

ISO 15394

Packaging - Bar Code and Two-Dimensional Symbols for Shipping, Transport and Receiving Labels-First Edition

ISO 15417

Information Technology - Automatic Identification and Data Capture Techniques - Bar Code Symbology Specification - Code 128-First Editon

ISO 15489- 1

Information and Documentation - Records Management - Part 1: General- First Edition

ISO 1562

Dentistry Casting gold alloys-Fourth Edition

ISO 15675

Cardiovascular Implants and Artificial Organs - Cardiopulmonary Bypass Systems - Arterial Line Blood Filters-First Edition

ISO 15747

Plastics containers for intravenous injection-First Edition

ISO 15798

Ophthalmic Implants - Ophthalmic Viscosurgical Devices-First Edition; Technical Corrigendum 1: 11/1/03

ISO 15814

Implants for Surgery - Copolymers and Blends Based on Polylactide - In Vitro Degradation Testing-First Edition

ISO 15882

Sterilization of Health Care Products - Chemical Indicators - Guidance for Selection, Use and Interpretation of Results-First Edition

ISO 16054

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 16269- 8

Statistical interpretation of data Part 8: Determination of prediction intervals-First Edition

ISO 16672

Ophthalmic Implants - Ocular Endotamponades-First Edition

ISO 17025

General requirements for the competence of testing and calibration laboratories-Second edition

ISO 17511

In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials-First edition

ISO 17664

Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices-First Edition

ISO 18153

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

ISO 19011

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

ISO 1942- 1

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

ISO 21535

Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants-First Edition

ISO 25539- 1

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses AMENDMENT 1: Test methods-First Edition; Amendment 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

Sampling Procedures for Inspection by Attributes - Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection-Second Edition; Corrigendum 1: 03-01-2001

ISO 2919

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

Water for Analytical Laboratory Use - Specification and Test Methods- First Edition

ISO 37

Rubber, vulcanized or thermoplastic - Determination of tensile stress- strain properties-Fourth Edition

ISO 3744

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

Dentistry - Polymer-Based Filling, Restorative and Luting Materials- Third Edition

ISO 407

Small Medical Gas Cylinders - Pin-Index Yoke-Type Valve Connections- Third Edition

ISO 4074

Natural Latex Rubber Condoms - Requirements and Test Methods- First Edition; Cancels and Replaces ISO 4074 Parts 1-10; Technical Corrigendum 1: 11/01/2003

ISO 4135

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

Low-Pressure Hose Assemblies for Use with Medical Gases-Second Edition

ISO 5361

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

ISO 5362

Anaesthetic Reservoir Bags-Third Edition

ISO 5364

Anaesthetic and Respiratory Equipment - Oropharyngeal Airways- Third Edition

ISO 5367

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

Accuracy (Trueness and Precision) of Measurement Methods and Results - Part 1: General Principles and Definitions-First Edition; Corrigendum 1- 1998

ISO 5725- 2

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

ISO 5725- 5

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

Implants for Surgery - Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Asymmetrical Thread - Dimensions First Edition

ISO 5840

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

Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers-Second Edition; TECHNICAL CORRIGENDUM 1: 11/15/2003

ISO 594- 1

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

ISO 594- 2

Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings-Second Edition

ISO 595- 1

Reusable All-Glass or Metal-and-Glass Syringes for Medical Use - Part 1: Dimensions-First Edition; Corrected and Reprinted - 1988

ISO 6009

Hypodermic Needles for Single Use - Colour Coding for Identification Third Edition; (CEN EN ISO 6009: 1994)

ISO 6710

Single-Use Containers for Venous Blood Specimen Collection First Edition; (Corrected and Reprinted - 1996)

ISO 6872

Dental Ceramic-Second Edition; Amendment 1-1997,Corrected and Reprinted 06/15/1998

ISO 7000

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

Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components-Second Edition

ISO 7198

Cardiovascular Implants - Tubular Vascular Prostheses-First Edition

ISO 7199

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

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)

ISO 7206- 4

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

ISO 7206- 6

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

ISO 7206- 8

Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion First Edition

ISO 7396

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

Dentistry - Preclinical Evaluation of Biocompatability of Medical Devices Used in Dentistry - Test Methods for Dental Materials-First Edition; Replaces ISO TR 7405

ISO 7741

Instruments for Surgery - Scissors and Shears - General Requirements and Test Methods First Edition

ISO 7864

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

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

ISO 8185

Humidifiers for Medical Use - General Requirements for Humidification Systems-Second Edition; Technical Corrigendum 1: 5/15/2001

ISO 8318

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

Ophthalmic Optics - Specifications for Material, Optical and Dimensional Properties of Contact Lenses - Part 1: Rigid Corneal and Scleral Contact Lenses-Second Edition

ISO 8321- 2

Ophthalmic Optics - Specifications for Material, Optical and Dimensional Properties of Contact Lenses - Part 2: Single-Vision Hydrogel Contact Lenses-Second Edition

ISO 8359

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

Resuscitators Intended for Use with Humans First Edition

ISO 8536- 10

Infusion equipment for medical use Part 10: Accessories for fluid lines for use with pressure infusion equipment-First Edition

ISO 8536- 11

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

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

ISO 8600- 4

Optics and Optical Instruments - Medical Endoscopes and Certain Accessories - Part 4: Determination of Maximum Width of Insertion Portion-First Edition

ISO 8601

Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times-Third Edition

ISO 8827

Implants for Surgery - Staples with Parallel Legs for Orthopaedic Use - General Requirements First Edition

ISO 8836

Suction Catheters for Use in the Respiratory Tract-Second Edition

ISO 8871- 3

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

ISO 9000

Quality Management Systems - Fundamentals and Vocabulary-Third Edition

ISO 90003

Software engineering Guidelines for the application of ISO 9001:2000 to computer software-First Edition;

ISO 9001

Quality Management Systems - Requirements-Third Edition; Supersedes ISO 9002:1994 and ISO 9003:1994

ISO 9004

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

Dental Brazing Materials First Edition; (CAN/CSA-Z349.45-93)

ISO 9339- 2

Optics and Optical Instruments - Contact Lenses - Determination of Thickness - Part 2: Hydrogel Contact Lenses-First Edition; Corrigendum 1: 04/15/2000

ISO 9360- 1

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

ISO 9585

Implants for Surgery - Determination of Bending Strength and Stiffness of Bone Plates First Edition

ISO 9626

Stainless Steel Needle Tubing for Manufacture of Medical Devices- Amendment 1:06/01/2001

ISO 9687

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 use-Second edition

ISO GUIDE 51

Safety Aspects - Guidelines for Their Inclusion in Standards-Second Edition

ISO GUIDE 63

Guide to the Development and Inclusion of Safety Aspects in International Standards for Medical Devices-First Edition

ISO TR 10013

Guidelines for Quality Management System Documentation-First Edition

ISO TR 10017

Guidance on statistical techniques for ISO 9001:2000-Second Edition

ISO TR 13425

Guidelines for the selection of statistical methods in standardization and specification-Second Edition

ISO TR 13570- 1

Wheelchairs Part 1: Guidelines for the application of the ISO 7176 series on wheelchairs-First Edition: Replaces ISO TR 13570:2001

ISO TR 14283

Implants for surgery Fundamental principles-Second Edition

ISO TR 14969

Medical devices Quality management systems Guidance on the application of ISO 13485:2003-First Edition; Replaces ISO 14969:1999

ISO TR 15300

Dentistry - Application of OSI Clinical Codification to the Classification and Coding of Dental Products-First Editon

ISO TR 15489- 2

Information and Documentation - Records Management - Part 2: Guidelines-First Edition

ISO TR 15844

Sterilization of Health Care Products - Radiation Sterilization - Selection of Sterilization Dose for a Single Production Batch-First Edition

ISO TR 16142

Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices-Second Edition

ISO TR 8550

Guide for the Selection of an Acceptance Sampling System, Scheme or Plan for Inspection of Discrete Items in Lots-First Edition

ISO TS 11139

Sterilization of Health Care Products - Vocabulary-Second Edition

ISO TS 11405

Dental Materials - Testing of Adhesion to Tooth Structure-Second Edition

ISO TS 13409

Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches- First Edition; Replaces ISO 13409

ISO TS 15539

Cardiovascular Implants - Endovascular Prostheses-First Edition

ISO TS 15843

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

ISO TS 20225

Global Medical Device Nomenclature for the Purpose of Regulatory Data Exchange-First Edition

ISO TS 21748

Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation-First Edition

ENGINEERING STANDARDS NEWS
November 5, 2009
ISO, ILAC, IAF Streamline Quality Mgmt. Requirements for Medical Labs
In a joint communiqué by the International Organization for Standardization (ISO), the International Laboratory Accreditation Cooperation (ILAC) ... more
October 30, 2009
ASTM D7558 Addresses Medical Glove Allergens
ASTM International issued a standard that allows rubber glove manufacturers to monitor the level of residual chemicals in their end products ... more
October 30, 2009
ANSI Begins Accreditation Under Toy Safety Certification Program
The American National Standards Institute (ANSI) accredited five certification bodies under the new Toy Industry Association (TIA) Toy Safety ... more
October 23, 2009
EU-China Standards Information Platform Launched
The European Committee for Standardization (CEN) announced the official launch of the new EU-China Standards Information Platform, a project ... more
October 16, 2009
DIN Announces Launch of Germany-China Standards Information Portal
The German Institute for Standardization (Deutsches Institut für Normung e.V., or DIN) announced the launch of the new Germany-China Standards ... more
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