EN ISO 10328:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Designations and symbols of test forces
   and moments
5 Strength and related performance
   requirements and conditions of use
6 Coordinate systems and test configurations
7 Test loading conditions and test loading levels
8 Values of test loads, 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 - Principal structural tests
17 Test procedures - Separate structural tests
18 Test laboratory/facility log
19 Test report
20 Classification and designation
21 Labelling
Annex A (informative) - Description of internal loads and
        their effects
Annex B (informative) - Reference data for the specification
        of test loading conditions and test loading levels of
        principal cyclic tests
Annex C (informative) - Guidance on the application
        of an alternative static ultimate strength test
Annex D (normative) - Guidance on the application
        of an additional test loading levels P6, P7 and P8
Annex E (informative) - Summary of the records to
        be entered in the test laboratory/facility log
Annex F (informative) - Background information on
        the loading profiles generated by test equipment
        according to 13.4.1.2 for separate cyclic tests
        for ankle-foot devices and foot units
        according to 17.2.5.1
Annex G (informative) - Reference to the essential principles
        of safety and performance of medical devices
        according to ISO/TR 16142
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
Bibliography

IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016.WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.