Prosthetics -- Structural testing of lower-limb prostheses
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.
Prothèses -- Essais portant sur la structure des prothèses de membres inférieurs
Standards Content (sample)
- Structural testing of
lower-limb prostheses -
Loading parameters of supplementary
- Essais portant sur la structure des protheses de membres
in f&ie urs -
Partie 6: Paramgtres de charge des essais suppkmen takes de structure
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IS0 (the International Organization for Standardization) is a worldwide fed-
eration of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are cir-
culated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
International Standard IS0 10328-6 was prepared by Technical Committee
I SO/TC 168, Prosthe tics and orthotics.
IS0 10328 consists of the following parts, under the general title
Pros the tics - Structural testing of lower-limb prostheses:
- Part 1: Test configurations
- Part 2: Test samples
- Part 3: Principal structural tests
- Part 4: Loading parameters of principal structural tests
- Part 5: Supplementary structural tests
Part 6: Loading parameters of supplementary structural tests
- Part 7: Test submission document
- Part 8: Test report
0 IS0 1996
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0 IS0 IS0 10328=6:1996(E)
Throughout all parts of IS0 10328, the term prosthesis means an
externally applied device used to replace wholly, or in part, an absent or
deficient limb segment.
As a result of concern in the international community about the need to
provide prostheses that are safe in use, and also because of an awareness
that test standards would assist the development of better prostheses, a
series of meetings was held under the aegis of the International Society
for Prosthetics and Orthotics (ISPO). The final meeting was held in
Philadelphia, PA, USA in 1977, at which a preliminary consensus was
reached on methods of testing and the required load values. From 1979
onwards this work was continued by IS0 Technical Committee 168,
leading to the development of this series of International Standards. The
test procedures may not be applicable to prostheses of mechanical
characteristics different from those used in the consensus.
During use, a prosthesis is subject to a series of load actions, each varying
individually with time. The test methods specified in IS0 10328 use static
and cyclic strength tests in which, with one exception, compound loadings
are produced by the application of a single test force.
The static tests relate to the worst loads generated in any activity. The
cyclic tests relate to normal walking activities where loads occur regularly
with each step. IS0 10328 specifies fatigue testing of structural
components. The tests specified do not provide sufficient data to predict
actual service life.
The evaluation of lower-limb prostheses and their components requires
controlled field trials in addition to the laboratory tests specified in the
different parts of IS0 10328.
The laboratory tests and field trials should be repeated when sign ificant
design changes are made to a oad-bearing part of a prost hesis.
Ideally, additional laboratory tests should be carried out to deal with
function, wear and tear, new material developments, environmental
influences and user activities as part of the evaluation procedure. There
are no standards for such tests, so appropriate procedures will need to be
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INTERNATIONAL STANDARD @ IS0
Prosthetics - Structural testing of lower-limb prostheses -
Loading parameters of supplementary structural tests
IS0 10328 specifies procedures for static and cyclic strength tests of 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 ofwalking.
The tests described in IS0 10328 apply to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses.
NOTE - The tests may be performed on complete structures, on partial structures, or on individual components.This part of IS0 10328 specifies
- the values of the offsets for setting up, aligning and loading the test sample, and
- the values of the test forces and moments to be applied for static and cyclic testing
for the different supplementary structural tests specified in IS0 10328-5 at the test load levels defined inIS0 10328-3.