• BS EN ISO 11334-1:2007

    Current The latest, up-to-date edition.

    Assistive products for walking manipulated by one arm. Requirements and test methods Elbow crutches

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-03-2007

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
      4.1 Cuff
      4.2 Handgrip
      4.3 Leg section and tip
      4.4 Adjusting devices
      4.5 Materials
      4.6 Mechanical durability
    5 Test methods
      5.1 General
      5.2 Testing environment
      5.3 Sampling
      5.4 Forearm withdrawal test
      5.5 Separation tests
      5.6 Static loading test
      5.7 Fatigue test
      5.8 Low temperature falling test
      5.9 Final inspection
    6 Information supplied by the manufacturer
      6.1 General
      6.2 Information marked on the product
      6.3 Documentation
    7 Test report
    Annex A (informative) Recommendations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements and test methods for elbow crutches fully equipped with handgrip and tip.

    Scope - (Show below) - (Hide below)

    This part of ISO11334 specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip. The methods specify testing of separation, static load capacity, fatigue and resistance to low temperature embrittlement.

    This part of ISO11334 also gives the requirements relating to safety, ergonomics, performance, and information to be supplied by the manufacturer, including marking and labelling.

    The requirements and tests are based on every-day usage of elbow crutches when performing the through-swing gait, for a maximum user mass as specified by the manufacturer. This part of ISO11334 is applicable to elbow crutches specified for a user mass of not less than 35kg.

    Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately.

    NOTE The recommendations given in AnnexA supplement the requirements given in this part of ISO11334.

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

    Committee CH/173
    Development Note Supersedes BS 4988(1990) & 92/50478 DC. (11/2005) Supersedes 05/30093244 DC. (03/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    EN 12182:2012 Assistive products for persons with disability - General requirements and test methods
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/IEC Guide 37:2012 Instructions for use of products by consumers
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO/IEC Guide 71:2014 Guide for addressing accessibility in standards
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
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