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I.S. 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 - PART 1: ELBOW CRUTCHES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2007

Preview

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.

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

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

DocumentType
Standard
Pages
26
PublisherName
National Standards Authority of Ireland
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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