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  • I.S. EN ISO 22523:2006

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    EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  National Standards Authority of Ireland

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    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
       4.1 Risk management
       4.2 Intended performance and technical documentation
       4.3 Clinical evaluation
       4.4 Strength and related conditions of use
    5 Requirements for materials
       5.1 Flammability of materials and toxicity of combustion
           products
       5.2 Biocompatibility, contaminants and residues
           5.2.1 General
           5.2.2 Contaminants and residues
       5.3 Infection and microbiological contamination
       5.4 Resistance to corrosion and degradation
    6 Noise and vibration
    7 Electromagnetic compatibility (EMC)
    8 Electrical safety
       8.1 Battery-powered prosthetic and orthotic devices
            8.1.1 Battery housings and connections
            8.1.2 Charge level indicators
       8.2 Circuit protection
       8.3 Electronic programmable systems
       8.4 Electrically heated blankets, pads and similar
            flexible heating appliances
       8.5 Prosthetic and orthotic devices with skin contact
            electrodes
       8.6 Prosthetic and orthotic devices with radio equipment
            8.6.1 General
            8.6.2 Frequency spectrum of radio equipment
            8.6.3 Operation of radio equipment by the user
    9 Surface temperature
    10 Sterility
    11 Design requirements
       11.1 Safety of moving parts
       11.2 Safety of connections
    12 Mechanical requirements
       12.1 Restrictions on use
       12.2 Forces in soft tissues of the human body
       12.3 Ergonomic principles
    13 Information supplied by the manufacturer
       13.1 General
       13.2 Labelling
       13.3 Intended use
    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 or moment required to operate the
                           control and actuating mechanisms on
                           prosthetic and orthotic devices
    Annex E (informative) Reference to the essential principles
                           of safety and performance of medical
                           devices in accordance with ISO/TR 16142
    ANNEX ZA (informative) Clauses of this European Standard addressing
                           essential requirements or other provisions
                           of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    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.

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

    Development Note Supersedes I.S. EN 12523. (06/2007)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    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) : 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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