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  • ISO 22523:2006

    Current The latest, up-to-date edition.

    External limb prostheses and external orthoses — Requirements and test methods

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French, Russian

    Published date:  14-09-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:

    • 06 03 - 06 15 Orthoses
    • 06 18 - 06 27 Limb prostheses

    It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.

    This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 168
    Development Note Supersedes ISO/DIS 22523 (09/2006)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN ISO 10328:2016 Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
    I.S. EN ISO 22675:2016 PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016)
    VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
    ISO/TS 16955:2016 Prosthetics — Quantification of physical parameters of ankle foot devices and foot units
    UNE-EN ISO 22675:2017 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    I.S. EN ISO 10328:2016 PROSTHETICS - STRUCTURAL TESTING OF LOWER-LIMB PROSTHESES - REQUIREMENTS AND TEST METHODS (ISO 10328:2016)
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    ISO 10328:2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
    13/30251846 DC : 0 BS ISO 16955 - PROSTHETICS - QUANTIFICATION OF PHYSICAL PARAMETERS OF ANKLE FOOT DEVICES AND FOOT UNITS
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    UNE-EN ISO 10328:2017 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
    BS EN ISO 22675:2006 Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
    EN ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    EN ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
    PD ISO/TS 16955:2016 Prosthetics. Quantification of physical parameters of ankle foot devices and foot units

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 8548-1:1989 Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies present at birth
    EN 894-3:2000+A1:2008 Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 3: Control actuators
    ISO 8548-3:1993 Prosthetics and orthotics Limb deficiencies Part 3: Method of describing upper limb amputation stumps
    ISO 8549-2:1989 Prosthetics and orthotics Vocabulary Part 2: Terms relating to external limb prostheses and wearers of these prostheses
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 10328:2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    ISO 8191-2:1988 Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source: match-flame equivalent
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13405-2:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 2: Description of lower limb prosthetic components
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    EN 614-1:2006+A1:2009 Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
    ISO 13405-1:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 1: Classification of prosthetic components
    IEC 60335-2-17:2012+AMD1:2015 CSV Household and similar electrical appliances - Safety - Part 2-17:Particular requirements for blankets, pads, clothing and similar flexible heating appliances
    ISO 15032:2000 Prostheses — Structural testing of hip units
    ISO 8549-3:1989 Prosthetics and orthotics Vocabulary Part 3: Terms relating to external orthoses
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    BS 2574-3:1990 Lower limb orthoses Method for the determination of mechanical properties of metal knee joint and side member assemblies
    EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 16201:2006 Technical aids for persons with disability — Environmental control systems for daily living
    EN 50082-2 : 95 AC 95 ELECTROMAGNETIC COMPATIBILITY - GENERIC IMMUNITY STANDARD - INDUSTRIAL ENVIRONMENT
    ISO 554:1976 Standard atmospheres for conditioning and/or testing — Specifications
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 13404:2007 Prosthetics and orthotics — Categorization and description of external orthoses and orthotic components
    ISO 13405-3:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 3: Description of upper limb prosthetic components
    BS DD180(1989) : 1989 GUIDE FOR THE ASSESSMENT OF TOXIC HAZARDS IN FIRE IN BUILDINGS AND TRANSPORT
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    ISO 8548-2:1993 Prosthetics and orthotics Limb deficiencies Part 2: Method of describing lower limb amputation stumps
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