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BS EN ISO 11334-1:2007

Current
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

03-30-2007

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

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

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.

Committee
CH/173
DevelopmentNote
Supersedes BS 4988(1990) & 92/50478 DC. (11/2005) Supersedes 05/30093244 DC. (03/2007)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current
Supersedes

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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