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  • 03/317861 DC : DRAFT OCT 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS

    Available format(s): 

    Superseded date:  31-10-2006

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Comment Closes On
    Committee CH/168
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By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 Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
    EN ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    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
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    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
    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 15032:2000 Prostheses — Structural testing of hip units
    ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
    EN 60967:1992/A51:1994 SAFETY OF ELECTRICALLY HEATED BLANKETS, PADS AND SIMILAR FLEXIBLE HEATING APPLIANCES FOR HOUSEHOLD USE
    BS 2574-3:1990 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 ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    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
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    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
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    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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