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ISO - Medical Collection

This collection contains documents from the following standards organization(s): International Organization for Standardization

ISO 14949 EN-Implants for Surgery - Two-Part Addition-Cure Silicone Elastomers-First Edition 
ISO 14971 EN-Medical devices - Application of risk management to medical devices-Second edition; Corrected Version 10/01/2007 
ISO 14972 EN-Sterile Obturators for Single Use with Overneedle Peripheral Intravascular Catheters-First Edition 
ISO 15001 EN-Anaesthetic and respiratory equipment - Compatibility with oxygen-Second Edition 
ISO 15002 EN-Flow-metering devices for connection to terminal units of medical gas pipeline systems-Second Edition 
ISO 15004-1 EN-Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments-First Edition; Together with ISO 15004-2 cancels and replaces ISO 15004:1997" "IUFHCAAAAAAAAAAA 
ISO 15004-2 EN-Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection-First Edition 
ISO 15010 EN-Disposable Hanging Devices for Transfusion and Infusion Bottles - Requirements and Test Methods-First Edition 
ISO 15032 EN-Prostheses - Structural Testing of Hip Units-First Edition 
ISO 15087-1 EN-Dental Elevators - Part 1: General Requirements-First Edition 
ISO 15087-2 EN-Dental Elevators - Part 2: Warwick James Elevators-First Edition 
ISO 15087-3 EN-Dental Elevators - Part 3: Cryer Elevators-First Edition 
ISO 15087-4 EN-Dental Elevators - Part 4: Coupland Elevators-First Edition 
ISO 15087-5 EN-Dental Elevators - Part 5: Bein Elevators-First Edition 
ISO 15087-6 EN-Dental Elevators - Part 6: Flohr Elevators-First Edition 
ISO 15098-1 EN-Dental Tweezers - Part 1: General Requirements-First Edition 
ISO 15098-2 EN-Dental Tweezers - Part 2: Meriam Types-First Edition 
ISO 15098-3 EN-Dental Tweezers - Part 3: College Types-First Edition 
ISO 15137 EN-Self-adhesive hanging devices for infusion bottles and injection vials Requirements and test methods-First Edition 
ISO 15142-1 EN-Implants for surgery Metal intramedullary nailing systems Part 1: Intramedullary nails-First Edition 
ISO 15142-2 EN-Implants for surgery Metal intramedullary nailing systems Part 2: Locking components-First Edition 
ISO 15142-3 EN-Implants for surgery Metal intramedullary nailing systems Part 3: Connection devices and reamer diameter measurements-First Edition 
ISO 15189 EN-Medical laboratories - Particular requirements for quality and competence-Second edition 
ISO 15190 EN-Medical laboratories Requirements for safety-First Edition 
ISO 15193 EN-In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures-Second Edition 
ISO 15194 EN-In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation-Second Edition 
ISO 15195 EN-Laboratory medicine Requirements for reference measurement laboratories-First Edition 
ISO 15197 EN-In Vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus-First Edition 
ISO 15198 EN-Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer-First Edition 
ISO 15223-1 EN-Medical devices - Symbols to be used with medical device labels labelling and information to be supplied - Part 1: General requirements-First edition 
ISO 15223-1 AMD 1 EN-Medical devices - Symbols to be used with medical device labels labelling and information to be supplied - Part 1: General requirements AMENDMENT 1-First edition 
ISO 15223-2 EN-Medical devices - Symbols to be used with medical device labels labelling and information to be supplied - Part 2: Symbol development selection and validation-First edition 
ISO 15225 EN-Medical devices - Quality management - Medical device nomenclature data structure-Second Edition 
ISO 15253 EN-Ophthamic Optics and Instruments - Optical Devices for Enhancing Low Vision-First Edition 
ISO 15254 EN-Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision-Second Edition 
ISO 15374 EN-Implants for Surgery - Requirements for Production of Forgings-First Edition 
ISO 15375 EN-Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods-Second Edition 
ISO 15378 EN-Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2000 with reference to Good Manufacturing Practice (GMP)-First Edition 
ISO 15606 EN-Dental Handpieces - Air-Powered Scalers and Scaler Tips-First Edition 
ISO 15621 EN-Urine-Absorbing Aids - General Guidance on Evaluation-First Edition 
ISO 1563 EN-Dental Alginate Impression Material-Second Edition; CAN/CSA-Z349.38-93 
ISO 1564 EN-Dental Aqueous Impression Materials Based on Agar-Second Edition; CAN/CSA-Z349.20-M92 
ISO 15674 EN-Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags-Second Edition 
ISO 15675 EN-Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters-Second Edition 
ISO 15676 EN-Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)-First Edition 
ISO 15747 EN-Plastic containers for intravenous injections-Second Edition 
ISO 15752 EN-Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety-Second Edition 
ISO 15759 EN-Medical Infusion Equipment - Plastics Caps with Inserted Elastomeric Liner for Containers Manufactured by the Blow-Fill-Seal (BFS) Process-Second edition 
ISO 15798 EN-Ophthalmic implants - Ophthalmic viscosurgical devices-Second Edition 
ISO 15814 EN-Implants for Surgery - Copolymers and Blends Based on Polylactide - In Vitro Degradation Testing-First Edition 
ISO 15841 EN-Dentistry Wires for use in orthodontics-First Edition 
ISO 15854 EN-Dentistry - Casting and baseplate waxes-First Edition; Replaces ISO 1561:1995 and ISO 12163:1999 
ISO 15882 EN-Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results-Second Edition 
ISO 15883-1 EN-Washer-disinfectors Part 1: General requirements terms and definitions and tests-First Edition 
ISO 15883-2 EN-Washer-disinfectors Part 2: Requirements and tests for washerdisinfectors employing thermal disinfection for surgical instruments anaesthetic equipment bowls dishes receivers utensils glassware etc.-First Edi 
ISO 15883-3 EN-Washer-disinfectors Part 3: Requirements and tests for washerdisinfectors employing thermal disinfection for human waste containers-First Edition 
ISO 15883-4 EN-Washer-disinfectors - Part 4: Requirements and tests for washerdisinfectors employing chemical disinfection for thermolabile endoscopes-First Edition 
ISO 15912 EN-Dentistry Casting investments and refractory die materials-First Edition; Supersedes ISO 7490:2000 ISO 9694:1996 ISO 11244:1999 ISO 11245:1999 and ISO 11246:1996 
ISO 16021 EN-Urine-Absorbing Aids - Basic Principles for Evaluation of Single-Use Adult-Incontinence-Absorbing Aids from the Perspective of Users and Caregivers-First Edition 
ISO 16034 EN-Ophthalmic optics - Specifications for single-vision ready-to-wear near-vision spectacles-First Edition 
ISO 16034 CORR 1 EN-Ophthalmic optics - Specifications for single-vision ready-to-wear near-vision spectacles-First Edition 
ISO 16037 EN-Rubber Condoms for Clinical Trials - Measurement of Physical Properties-First Edition 
ISO 16038 EN-Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms-First Edition 
ISO 16054 EN-Implants for Surgery - Minimum Data Sets for Surgical Implants-First Edition 
ISO 16059 EN-Dentistry - Required elements for codification used in data exchange-First Edition 
ISO 16061 EN-Instrumentation for use in association with non-active surgical implants - General requirements-Second Edition 
ISO 16201 EN-Technical aids for persons with disability Environmental control systems for daily living-First Edition 
ISO 16284 EN-Ophthalmic optics Information interchange for ophthalmic optical equipment-Second Edition 
ISO 16391 EN-Aids for Ostomy and Incontinence - Irrigation Sets - Requirements and Test Methods-First Edition 
ISO 16402 EN-Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics-First Edition 
ISO 16428 EN-Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices-First edition 
ISO 16429 EN-Implants for surgery Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods-First Editon 
ISO 16628 EN-Tracheobronchial tubes - Sizing and marking-First Edition 
ISO 16671 EN-Ophthalmic implants Irrigating solutions for ophthalmic surgery-First Edition 
ISO 16672 EN-Ophthalmic Implants - Ocular Endotamponades-First Edition 
ISO 16840-1 EN-Wheelchair seating Part 1: Vocabulary reference axis convention and measures for body segments posture and postural support surfaces-First Edition 
ISO 16840-2 EN-Wheelchair seating - Part 2: Determination of physical and mechanical characteristics of devices intended to manage tissue integrity - Seat cushions-First Edition 
ISO 16840-3 EN-Wheelchair seating Part 3: Determination of static impact and repetitive load strengths for postural support devices-First Edition 
ISO 16840-4 EN-Wheelchair seating - Part 4: Seating systems for use in motor vehicles-First Edition 


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