BS EN ISO 10328:2016

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

Describes procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced by the application of a single test force.

IMPORTANT This International Standard is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO22523:2006 (see NOTE1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO22523:2006 through submission to the relevant tests of ISO10328:2006, need not be retested to ISO22675:2016.

WARNING This International Standard 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.

This International Standard 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.

The tests described in this International Standard comprise

• principal static and cyclic tests for all components;

• a separate static test in torsion for all components;

• separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;

• a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;

• separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.

The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses (see NOTE2), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE3).

NOTE1 The tests can be performed on complete structures, on part structures or on individual components.

NOTE2 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic ankle-foot devices taken from the normal production line.

NOTE3 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip units are described in ISO15032.