ISO 10328-4:1996

Prosthetics — Structural testing of lower-limb prostheses — Part 4: Loading parameters of principal 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.

Prothèses — Essais portant sur la structure des prothèses de membres inférieurs — Partie 4: Paramètres de charge des essais principaux de structure

General Information

• Status: Withdrawn
• Publication Date: 11-Dec-1996
• Withdrawal Date: 11-Dec-1996
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 168 - Prosthetics and orthotics
• Drafting Committee: ISO/TC 168/WG 3 - Testing
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 14-Sep-2006

Relations

• Revised: ISO 10328:2006 - Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL IS0
STANDARD 10328-4
First edition
1996-l 2-15
Prosthetics - Structural testing of
lower-limb prostheses -
Part 4:
Loading parameters of principal structural
tests
Protheses - Essais portant sur la structure des protheses de membres
inf&ieurs -
Partie 4: Parami,tres de charge des essais princlpaux de structure
Reference number
IS0 10328-4:1996(E)

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international Standard IS0 103284 was prepared by Technical Committee
lSO/rC 168, Prosthetics and orthotics.
IS0 10328 consists of the following parts, under the generai title
Prosthetics ~ Structural testing of lower-limb prostheses:
- Part 7: Test configurations
- Part 2: Test samples
- Part 3: Princlpai structural tests
Part 4: Loading parameters of principal structural tests
Part 6: Loading parameters of supplementary structural tests
- Part 7: Test submission document
- Part 8: Test report
Annex A of this part of IS0 10328 is for information only.
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be
reproduced or utilized in any form or by any means, electronic or mechanical, including
photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 m CH-1211 Gengve 20 e Switzerland
Printed in Switzerland

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@ IS0 IS0 10328=4:1996(E)
Introduction
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.
field trials should
The laboratory tests and be re peated when significant
design changes are made to a I oad-bearing p art 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
specified.

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INTERNATIONAL STANDARD 0 IS0 IS0 10328=4:1996(E)
Prosthetics - Structural testing of lower-limb prostheses -
Part 4:
Loading parameters of principal structural tests
1 Scope
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 of
walking.
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 to be applied for static and cyclic testing
for the different test loading conditions and test load levels in accordance with IS0 10328-3:1996, subclauses 4.32
and 4.4.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part
of IS0 10328. At the time of publication, the editions indicated were valid. All standards are subject to revision, and
parties to agreements based on this part of IS0 10328 are encouraged to investigate the possibility of applying the
most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently
valid International Standards.
IS0 8549-l : 1989, Prosthetics and orthotics - Vocabulary - Part 7: General terms for external limb prostheses and
external orthoses.
IS0 10328-3: 1996, Prosthetics - Structural testing of lower-limb prostheses - Part 3: Principal structura/ tests.

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IS0 10328-4: 1996(E)
3 Definitions
For the purposes of this part of IS0 10328, the definitions in IS0 8549-l apply.
4 General
4.1 Test load levels
Because of the significant differences in the characteristics of use of lower-limb prostheses by adults and by
children, separate series of test load levels are required.
The series A test load levels, applied to lower-limb prostheses for adults, are designated as given in table 1. Details
of each test load level are specified in tables 3 to 6.
The details of test lo
...