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I.S. EN ISO 22675:2016

Current
Current

The latest, up-to-date edition.

PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

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.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces
5 Strength and related performance requirements
   and conditions of use
6 Coordinate system and test configurations
7 Test loading conditions and test loading levels
8 Values of test forces, dimensions and cycles
9 Compliance
10 Test samples
11 Responsibility for test preparation
12 Test submission document
13 Equipment
14 Accuracy
15 Test principles
16 Test procedures
17 Test laboratory/facility log
18 Test report
19 Classification and designation
20 Labelling
Annex A (informative) - Reference data for the specification
        of the test loading conditions and test loading levels
        of this International Standard
Annex B (informative) - Guidance on the application of an
        alternative static ultimate strength test
Annex C (normative) - Application of an additional test loading
        level P6, P7, and P8
Annex D (informative) - Summary of the records to be entered
        in the test laboratory/facility log
Annex E (informative) - Information on Technical Report
        ISO/TR 22676
Annex F (informative) - Reference to the essential principles
        of safety and performance of medical devices according
        to ISO/TR 16142
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC [OJ L 169] aimed to be covered

Defines a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.

DocumentType
Standard
Pages
112
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

ISO 10328:2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
ISO/TR 22676:2006 Prosthetics Testing of ankle-foot devices and foot units Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

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