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  • EN 12523 : 1999

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS

    Available format(s): 

    Superseded date:  01-10-2006

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Definitions
    4 General requirements
    5 Requirements for materials
    6 Noise and vibration
    7 Electromagnetic compatibility (EMC)
    8 Electrical safety
    9 Surface temperature
    10 Sterility
    11 Design requirements
    12 Mechanical requirements
    13 Information supplied by the manufacturer
    14 Packaging
    Annex A (informative) Guidance on methods of determining
    the strength of upper limb prosthetic devices
    Annex B (normative) Method of determining the mechanical
    properties of knee joint assemblies for lower limb orthotic
    devices
    Annex C (informative) Guidance on methods of determining
    the flammability and toxicity of combustion products of
    lower limb prosthetic devices
    Annex D (informative) Guidance on methods of establishing
    the force required to operate the controls on prosthetic and
    orthotic devices
    Annex E (informative) Bibliography
    Annex Z (informative) Clauses of this European Standard
    addressing essential requirements or other provisions of EU
    Directives

    Abstract - (Show below) - (Hide below)

    Covers test methods and requirements for external limb prostheses and external orthoses, including the following classifications from EN ISO 9999: 06 03 - 06 15 Orthoses, 06 18 - 06 27 Limb prostheses. Covers materials, strength, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. Does not cover special seating as it is not classified as an orthosis in EN ISO 9999 and it is not normally body-worn.

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    Committee TC 293
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    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
    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
    EN ISO 9999:2016 (edition 5) Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
    ISO 10328-1:1996 Prosthetics Structural testing of lower-limb prostheses Part 1: Test configurations
    ISO 10328-4:1996 Prosthetics Structural testing of lower-limb prostheses Part 4: Loading parameters of principal structural tests
    ISO 10328-3:1996 Prosthetics Structural testing of lower-limb prostheses Part 3: Principal structural tests
    ISO 8191-2:1988 Furniture Assessment of ignitability of upholstered furniture Part 2: Ignition source: match-flame equivalent
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    ISO 10328-8:1996 Prosthetics Structural testing of lower-limb prostheses Part 8: Test report
    ISO 10328-5:1996 Prosthetics — Structural testing of lower-limb prostheses — Part 5: Supplementary structural tests
    ISO 13405-2:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 2: Description of lower limb prosthetic components
    EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
    EN 60601-1-1:2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
    ISO 13405-1:2015 Prosthetics and orthotics Classification and description of prosthetic components Part 1: Classification of prosthetic components
    ISO 8549-3:1989 Prosthetics and orthotics Vocabulary Part 3: Terms relating to external orthoses
    ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
    ISO 10328-2:1996 Prosthetics Structural testing of lower-limb prostheses Part 2: Test samples
    EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    EN 60967:1992/A51:1994 SAFETY OF ELECTRICALLY HEATED BLANKETS, PADS AND SIMILAR FLEXIBLE HEATING APPLIANCES FOR HOUSEHOLD USE
    ISO 10328-7:1996 Prosthetics Structural testing of lower-limb prostheses Part 7: Test submission document
    BS 2574-3(1990) : 1990 LOWER LIMB ORTHOSES - METHOD FOR THE DETERMINATION OF MECHANICAL PROPERTIES OF METAL KNEE JOINT AND SIDE MEMBER ASSEMBLIES
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    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
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    ISO 10328-6:1996 Prosthetics Structural testing of lower-limb prostheses Part 6: Loading parameters of supplementary structural tests
    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
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    ISO 8548-2:1993 Prosthetics and orthotics Limb deficiencies Part 2: Method of describing lower limb amputation stumps
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