ISO/TC 168/WG 3 - Testing

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.

IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units 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 this International Standard. WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees. ISO 22675:2016 primarily specifies 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. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, ISO 22675:2016 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test. The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle. The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.

ISO/TR 22676:2006 offers guidance on: the specification of the test loading conditions of ISO 22675; the design of appropriate test equipment. Most of the text of ISO/TR 22676:2006 relates to the theoretical and technical background and the design of the equipment.

ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 - 06 15 Orthoses 06 18 - 06 27 Limb prostheses It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

This International Standard specifies test methods for components and assemblies of hip disarticulation prostheses which are arranged at hip and thigh level. It does not apply to other components of lower limb prostheses for which test methods are given in ISO 10328. This International Standard specifies procedures for simplified static and cyclic strength tests in which the anteroposterior (A-P) and medio-lateral (M-L) components of loading are produced in separate tests by the application of test forces in two different test planes. The components of loading produced 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.

ISO 22675:2006 primarily specifies 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. In addition, ISO 22675:2006 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.

ISO 10328:2005 specifies 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. 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 ISO 10328:2005 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 ISO 10328:2005 apply to specific types of ankle-disarticulation prostheses, to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses.

Describes procedures for static and cyclic strength test for lower-limb prostheses. Specifies the information that shall be provided in the test report which is prepared for each test conducted in accordance with ISO 10328 and ISO 10328-4 and/or ISO 10328-5 and ISO 10328-6.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies supplementary structural tests.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the values of the test forces.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the information that must be provided on the test submision document which accompanies each item for testing.

Gives test configurations for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Defines coordinate systems, the location of a test sample and the position of the line of application of the test force.

Contains procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies methods to be used in carrying out principal static and cyclic tests, requirements for accuracy of the tests and criteria to be met in order to secure compliance with this part of ISO 10328.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies types, selection, preparation and alignment of test samples and responsibilities for test preparation.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the values of the test forces and moments for the supplementary structural tests.