INTERNATIONAL

STANDARD

First edition
2000-04-1 5

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Prostheses - Structural testing of hip units

Protheses - Essais portant sur la structure des protheses de ha; :;/I.-=

TUSl L i b r a r y
Kauau a u 1 n s ) l u

Reference number
IS0 15032:2000(E)

1 5 ?ItR 2 5 4 2
1
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0 ISC 2000
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Foreword
I S 0 (the lnternational Organization for Standardization) is a worldwide federation of national standards bodies (IS0
member bodies). The work of preparing lnternational 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. lnternational organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. IS0 collaborates closely with the lnternational Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.

InternationalStandards are drafted in accordance with the rules given in the ISOIIEC Directives, Part 3.

Draft lntemational Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an lnternational Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this lnternational Standard may be the subject of
patent rights. I S 0 shall not be held responsible for identifying any or all such patent rights. •
lnternational Standard IS9 15032 was prepared by Technical Committee lSO/TC 168, Prosthetics and orthotics.

Annex A forms an integral part of this lnternational Standard. Annex 6 is given for information only.

8 I S 0 2000 - Ali rights resewed

 Introduction
Throughout this International Standard, the term prosthesis means an externally applied device used to replace
wholly, or in part, an absent or deficient limb segment.

During use a prosthesis is subject to a series of load actions each varying individually with time. The test methods
specified in this International Standard use simplified static and cyclic strength tests in which antero-posterior (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 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. This International Standard specifies fatigue testing of structural
components. The tests specified do not provide sufficient data to predict actual service life.

The evaluation of hip disarticulation prostheses and their components requires controlled field trials in addition to
@ the laboratory tests specified in this lnternational Standard.

The laboratory tests and field trials should be repeated when significant design changes are made to ,; load-
bearing part of a prosthesis.

Ideally, additional laboratory tests should be carried out to ,deal with function, wear and tear, new material
developments, environmental influences, and amputee 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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I INTERNATIONAL STANDARD ' IS0 15032:2000(E)

Prostheses - Structural testing of hip units

1 Scope
This International Standard specifies test methods for components and assemblies of hip disarticulation pr~stheses
which are arranged at hip and thigh level. It does not apply to other components of lower limb piastheses 'rrr which
test methods are given in I S 0 10328.

This lnternational Standard specifies procedures for simplified static and cyclic strength tests irtwhich iI it. antero-
posterior (A-P) and medio-lateral (M-L) components of loading are produced in separate tests bythe apphi:ation of
test forces in two different test planes. The components of loading produced in the test sample relate tr he peak
) values of the components of loading which normally occur at different instants during the stance phase of ir~nlking.

2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provis ms of
this lntemational Standard. For dated references, subsequent amendments to, or revision% of, any o; ~hese
publications do not apply. However, parties to agreements based on this lnternational Standard gre encourc;:red to
investigate the possibility of applying the most recent edit~onof the normative document indicated below For
undated references, the latest edition of the normative document referred to applies. Members of IS0 atx! IEC
maintain registers of currently valid lnternational Standards.

IS0 8549-1:1989, Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb prostheses
and external orthoses.

3 Terms and definitions

For the purposes of this lnternational Standard, the terms and definitions given in IS0 8549-1 and the following
8 apply.

3.1
brittle failure
fracture of any component without significant plastic deformation at the fracture

3.2
ductile failure
(...) fracture of any component with significant plastic deformation at the fracture

3.3
ductile failure
(...) gross plastic deformation of the test sample

3.4
test equipment
any test machine or device adapted or specifically designed to the test requirements of this lnternational Standard
and complying with the requirements on accuracy of 6.8

O IS0 20G3 - All rights reserved

4 Test configurations

4.1 General
4.1.1 For ease in interpretation, presentation and application of this International Standard, two test
configurations are specified, one for right-sided application and a mirror image for left-sided application. This
approach enables the application of uniform sign conventions for corresponding components of loading generated
in the load-bearing structures of right and left prostheses or asymmetrically designed prosthetic components.

4.1.2 Each test configuration is defined in a three-dimensional, rectangular coordinate system, containing a
geometric system of planes, lines and points (see Figures 1 and 2).

4.1.3 Each test configuration specifies reference parameters both for the position of the line of application of the
test force and for the alignment of test samples within the coordinate system.

4.2 Axes of coordinate system

4.2.1 The axes of each of the coordinate systems have an origin at ground level and are specified in 4.2.2 to
4.2.4 in relation to a prosthesis which is standing on the ground in a vertical position.

If a test sample is not in a vertical position, the axes of the coordinate system shall be rotated to correspond.

4.2.2 The u'-axis is a line extending from the origin and passing through the effective knee-joint centre (see
5.5.2.2) and the effective hip-joint centre (see 5.5.2.4). Its positive direction is upwards (in the proximal direction).

4.2.3 The 0'-axis is perpendicular to the u'-axis and parallel to the effective hip-joint centreline (see 5.5.2.3). Its
positive direction is outward (in the lateral direction), which is to the left for a left prosthesis and to the right for a
right prosthesis.

4.2.4 The f '-axis is perpendicular to both the of-axis and the u'-axis. Its positive direction is forward towards the
toe (in the anterior direction).

4.3 Reference planes

The reference planes (see Figure 1) shall be parallel planes perpendicular to the u'-axis of the coordinate system.

4.3.1 Bottom reference plane, BK

The bottom reference plane. BK, is located at a distance u' = u l s from

~ the origin. It contains the bottom load
application point PBK.

4.3.2 Knee reference plane, K

The knee reference plane, K, is located at a distance u' = from the origin. It contains the effective knee-joint
l t ' ~

centre (see 5.5.2.2).

4.3.3 Hip reference plane, H

The hip reference plane, H, is located at a distance u' = u ' from

~ the origin. It contains the effective hip-joint centre
(see 5.5.2.4).

4.3.4 Top reference plane, TH

The top reference plane, TH, is located at a distance U' = utTHfrom the origin. It contains the top load application
point PTH. ..

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 Key
& 1
2
Top reference plane, TH
Hip reference plane, H
3 Knee reference plane, K
4 Bottom reference plane, BK
a Right
b Left

Figure 1 - Coordinate system according to 4.2 with reference planes

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-.
 f' F/
a) A-P ext. test loading condition b) A-P flex. test loading condition

F'

Key
1 Effective lever arm, LH
hip joint centre
knee joint centre
4 Effective lever arm
1 5 Effective hip joint centre line
I 6 Effective knee joint centre line
7 Effective hip joint centre
8 Effective knee joint centre
c) M-L test loading condition
Figure 2 - Test configurations for A-P and M-L tests inf '-u'- and o'-u'- plane

O I S 6 2000 - All rights reserved

 4.4 Reference points

The reference points shall be the points of intersection of the load line (see 4.6) with the reference planes. The
coordinates of the reference points are as follows:

bottom load application point P B (fVBK,

~ O'BK. utBK);

knee load reference point PK ( f f K , O'K, urK);

hip load reference point PH (ffH, O'H, upH);

top load application point PTH(fPTH, O ~ H utTH).

,

NOTE In the following text the f '-and 0'-coordinates are also referred to as offsets (see also 4.7).

4.5 Test force

' The test force F shall be a single compressive load applied to the bottom and top load application points PBKand
PTH.

4.6 Load line

The load line shall be the line of application of the test force F which passes through the reference points PK and
pH.

4.7 Reference distances

4.7.1 Offsets

The offsets shall be the perpendicular distances of the reference points (see 4.3.1 and 4.4) from the o-U-planeand
the u-f-plane of the coordinate systems (see 4.1 and 4.2). They are identical with the corresponding fl-or 0'-
coordinates, respectively, of these reference points.

4.79 Effective lever arms

8 The effective lever arms shall be the perpendicular distances from the load line to the effective joint centres (see
5.5.2.2 and 5.5.2.4). where LKrepresents the knee effective lever arm and LH the hip effective lever arm.

4.7.3 Distance LBK-TH

LBK-THshall be the distance between the bottom load application point PBK (see 4.3.1 and 4.4) and the top load
application point PTH(see 4.3.4 and 4.4).

5 Test samples

5.1 Types of test sample

5.1.1 Number of types

There are two types of test sample, as described in 5.1.2 and 5.1.3.

Q IS0 2000 - P.II rights reserved

5.12 Complete structure

The complete structure shall comprise the hip unit and at least the following:

a) thigh segment or suitable attachment;

b) any special attachment at the knee; and/or

c) any parts above the hip unit including the socket.

5.1.3 Hip unit

The hip unit shall be attached to suitable attachments to give the same overall dimensions as the complete
structure.

The interface of such attachments shall have mechanical characteristics similar to those of the intended adjacent
components.

5.2 Responsibilities regarding selection, preparation and alignment of test samples

5.2.1 The manufacturer/submitter shall be responsible for the selection and assembly of the components to be
tested, and for the provision of specified parts to be replaced during the cyclic tests.

5.2.2 The manufacturerlsubmitter shall be responsible for preparing the test submission document complete w ~ t h
alignment andlor service instructions, as necessary.

5.2.3 The manufacturerlsubmitter shall apply a unique and traceable identificationto each test sample.

5.2.4 The load application levers (see 6.2.1) shall be attached by either the manufacturerlsubmitter or the test
laboratorylfacility.

5.2.5 The test laboratorylfacility shall seek the advice of the manufacturerlsubmitter if the specific design of hip
units incorporates any special characteristics.

5.2.6 The test laboratorylfacility shall be responsible for adjustment of the alignment to give the correct offsets
and effective lever arms during test.

5.3 Selection of test samples

If appropriate, the prosthetic structures selected for test shall be drawn from standard production. Details of the
e
selection shall be recorded in the test submission document. If the manufacturer1submitter supplies a certificate
stating that the test sample has been taken from the normal production, this certificate shall be included in the test
submission document, together with details of the sampling method.

5.4 Preparation of test samples

Any cosmetic components shall be omitted from the test sample, unless they contribute to the structural strength.

The test samples shall include all parts normally fitted.

NOTE During the course of the cyclic tests, specified parts are replaced when the number of cycles has reached a value at
which such replacement is indicated in accordance with the manufacturer's/submitter's service instructions and/or the test
submission document.

The test sample including any end fittings shall be assembled in accordance with the respcinsibilities regarding the
preparation of the test sample and the test submission document.

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 5.5 Alignment of test samples

5.5.1 General requirement

All test samples shall be aligned in accordance with the responsibilities regarding the alignment of the test samples
(see 5.2)and the requirements specified in 5.5.2.

5.5.2 Description of effective centres and effective centrelines

5.5.2.1 Effective knee-joint centreline

For a monocentric knee unit without a lock or stance phase control mechanism, the effective knee-joint centreline
shall coincide with the joint flexion axis.

For all other knee units, the effective knee-joint centreline shall be established from the manufacturefs/submittefs
written alignment instructions included in or submitted with the test submission document.

The effective knee-joint centreline shall lie in the 0'- u'- plane of the coordinate system parallel to the effective hip-
joint centreline.
8
5.5.2.2 Effective knee-joint centre

The effective knee-joint centre shall lie on the effective knee-joint centreline.

For symmetrical knee units, the effective knee-joint centre shall be the point on the effective knee-joint centreline
equidistant from the external boundaries of the unit.

For asymmetrical or handed knee units, the position of the effective knee-joint centre shall be established from the
manufacturer's/submitter's written alignment instructions for the knee unit included in or submitted with the test
submission document.

5.5.2.3 Effective hipjoint centreline

For a monocentic hip unit without a lock or stance phase control mechanism, the effective hip-joint centreline shall
coincide with the joint flexion axis.

For all other hip units, the effective hip-joint centreline shall be established from the manufacturerls/submitter's
written alignment instructions included in or submitted with the test submission document.

The effective hip-joint centreline shall lie in the 0'-u'-plane of the coordinate system parallel to the 0'-axis.

5.5.2.4 Effective hip-joint centre

The effective hip-joint centre shall lie on the effective hip-joint centreline.

For symmetrical hip units, the effective hip-joint centre shall be the point on the effective hip-joint centreline
equidistant from the external boundaries of the unit.

For asymmetrical or handed hip units, the position of the effective hip-joint centre shall be established from the
manufacturer's/submitter's written alignment instructions for the hip unit included in or submitted with the test
submission document.

5.5.3 Worst case alignment

The structurally worst alignment position of the test sample shall be defined by the manufacturer/submitter in the
test submission document. It shall lie within the limitations of the manufacturer's/submitter'swritten instructions for
the alignment of the limb as supplied with every component of the type.

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Where the structurally worst position cannot be defined, then the test sample shall be adjusted so that it is moved
90 % of the distance from neutral alignment to extreme alignment. The adjustment shall be directed away from the
load line so as to increase the effective lever arm.

6 Test requirements and conditions

6.1 Types of test

6.1.1 Static tests

Each static test shall consist of a single load application to a sample.

The static tests shall consist of a static proof test, a static failure test and a static torsional proof test.

6.1 2 Cyclic tests

The cyclic tests shall consist of repeated applications of a load to a test sample.

Each cyclic test shall be followed by a final static load test.

6.2 Test loading requirements

6.2.1 Test loading principle

In order to allow the test loading conditions to be applied in a uniform and reproducible manner, the position of the
load line in relation to the test sample shall be established through application of the following test loading principle:

d) for loading, the positions of the load line within the coordinate system shall be such that the test force is
applied either in the f '- (('-planeor in the or- it'-plane (see Figures 1 and 2);

e) the test sample shall be assembled to a fixed length using end attachments consisting of extension pieces as
required and the load application levers;

f) the test sample shall be set up either in the f'- u'-plane or in the 0'-14'-plane of the coordinate system with the
bottom and top load application levers adjusted so that the knee and hip offsets are correct;

g) no corrections shall be made to the load application levers if the test sample deflects under the test loading @
conditions, and this deflection alters the initial knee and hip offsets.

6.2.2 Test loading conditions

6.2.2.1 General

The test loading conditions for A-P, M-L and torsional tests are based on internal reference loads, consisting of an
axial force, bending moments and a twisting moment. These are described in annex A together with their effects.

NOTE Further reference data are given in annex B together with several sets of formulae for calculating specific values of
axial force, effective lever arms and offsets.

6.2.2.2 A-P plane test loading conditions

In the A-P plane test loading conditions shown in Figures 2 a) and 2 b), the components of loading shall be
produced by the application of a single test force in the f '- ul-plane of the coordinate system.

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 Two different A-P plane test loading conditions are specified and each shall be applied in a static proof and failure
test procedure and a cyclic test procedure (see 6.4):

a) the A-P extension test loading condition shown in Figure 2 a) shall be applied to all hip units;

b) the A-P flexion test loading condition shown in Figure 2 b) shall be applied to hip units with a stride limiter in
addition to the A-P extension test loading condition.

6.2.2.3 M-L plane test loading condition

In the M-L plane test loading condition shown in Figure 2 c), the components of loading shall be produced by the
application of a single test force in the 0'-u'- plane of the coordinate system.

The M-L plane test loading condition shall be applied in a static proof and failure test procedure and a cyclic test
procedure (see 6.4).

6.2.2.4 Torsional test loading condition

The A-P plane and M-L plane test loading conditions shall be supplemented by a separate torsional test loading
8 condition to be applied about the ul-axis in a static and a cyclic test procedure (see 6.5).

62.3 Test loading levels

The load actions to which a lower limb prosthesis is actually subjected during use vary with individual physical
parameters, locomotion characteristics of the user and other factors. For these reasons different categories of
prostheses are needed and, consequently, different test loading levels are specified.

The series A test loading levels A100, A80 and A60 shall apply to lower-limb prostheses for adults.

NOTE 1 For test loading levels A100, A80 and A60, the values for the dimensions and test loads of the A-P, M-L and
torsional test loading conditions are specified in Tables 3 and 4.

NOTE 2 Test loading levels A100, A80 and A60 correspond to the series A test loading levels specified in IS0 10328-3.

6.3 Requirements and conditions relevant to test procedures and equipment

6.3.1 General

Set the dimensions of the test pieces and attachments, and the test loads in accordance with the values specified
in clause 7. Carry out any single test in accordance with the particular requirements stated in the test submission
document submitted with each test sample.

Ensure that the test equipment has sufficient freedom of movement to permit unrestricted deformation of the test
sample.

Ensure that any attachments to the test sample do not enhance or relieve the specified test loads in the structure
under test.

Ensure that any records called for are entered in the test laboratory/facility log and copied to the test report, in
accordance with clause 9.

6.3.2 Proof test of end attachments used for A-P and M-L tests

6.3.2.1 General

Carry out a proof test of end attachments consisting of the load application levers and any extension pieces used,
and measure their stiffness in either of the manners specified in 6.3.2.2 and 6.3.2.3 (see note 1).

0 I S 0 2000 - All riykts reserved

 *
I "
,,l;J,j~i;;,!io~~U'~~Y~s"~~~~~~~~
Y

I
NOTE 1 The method of proof test specified in 6.3.2.2 can result in test configurations in which the position of the assembly of
end attachments will be inclined relative to the line of load application at a greater angle than in the relevant test situation with a
test sample. If the assembly cannot be tested in such a position, the alternative method of proof test specified in 6.3.2.3 may be
applied.

I NOTE 2 It may be necessary to apply the proof test of end attachments to different sets of end attachment, individually
designed to the requirements of the different test loading conditions.

NOTE 3 It is not necessary to repeat the proof test of end attachments if earlier test results for previously tested relevant
combinations of end attachments are available and are suitable.

1 6.322

6.32.2.1
Standard proof test of end attachments

Assemble together any nonprosthetic components used in the test sample for the application of a
I
specific test loading condition. Set both load application levers in the same direction.

I If the extension pieces used have means of adjustment, this shall be set to the worst structural condition.

If it is necessary to use additional components to allow assembly of end attachments, the stiffness oi :.!~ese
components shall not be less than the stiffness of the other nonprosthetic components when asshbled in :$Is
test
situation.

6.3.2.2.2 Within the range of adjustability required for the test loading condiiion to be applied, se; bct: ,i-ver
arms in the same direction to their maximum length.

I 6.3.2.2.3

6.3.22.4
Place the assembly in the test equipment.

Apply to the assembly the settling force Fset of the A-P and M-L test loading conditions at the :~;r;:~ant
test loading level, specified in Table 4.

I Maintain this force, FSet, for a period between 10 s and 30 s, and then remove it.

6.3.2.2.5 Apply to the assembly the stabilizing test force Fstab specified in Table 4 and maintain it until the
measurement specified below is completed.

Measure and record the distance L B K - Tas ~ L1 or the displacement 6of the moving load application point (e.g. the
cross-head) from its reference.position in the test equipment as 6 i .

6.3.2.2.6 Increase the test force smoothly at a rate between 100 Nls and 250 Nls to the proof test force Fp, of
the A-P and M-L test loading conditions at the relevant test loading level, specified in Table 4. @
Maintain this force, F,,,, until the measurement specified below is completed.

Measure and record the distance LBK-TH as L2 or the displacement 6of the moving load application point !e.g. the
cross-head) from its reference position in the test equipment as a2,

6.3.2.2.7 Decrease the test force to Fstab and maintain it until the measurement specified below is completed.

Measure and record the distance L B K - ~ as

H L3 or the displacement 6of the moving load application point (e.g. the
cross-head) from its reference position in the test equipment as S3.

6.3.2.2.8 Calculate and record the deflection Dl at Fpa, and the permanent deformation LI2 at Fstab, respectively,
between the bottom and top load application points as follows:

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 6.3.2.2.9 Do not use the end attachments if the measured values exceed the following limits:

maximum deflection at Fp, Dl = 2 mm;

maximum permanent deformation at Fstab D 2 = 1 mm.

6.3.2.2.10 Record the results of the test.

6.3.2.3 Alternative proof test of end attachments

6.3.2.3.1 Assemble together two identical sets of end attachment used either on the bottom or on the top side of
the test sample for the application of a specific test loading condition. Set both load application levers in the same
direction.

Ifthe extension pieces used have a means of adjustment, this shall be set to the worst structural condition.

If it is necessary to use additional components to allow assembly of end attachments, the stiffness of these
components shall not be less than the stiffness of the other nonprosthetic components when assembled in the test

' situation.

NOTE Each set of end attachment consists of the load application lever. the extension piece and additional components. if
necessary, to be connected to one end of the test sample. An example of an assembly of two identical sets of end attachment is
the assembly of two bottom load application levers and associated components for the M-L test.

6.3.2.3.2 Continue the test, following the instructions in 6.3.2.2.2 to 6.3.2.2.7

6.3.2.3.3 Calculate the deflection of the assembly of two identical sets of end attachment D l , w~ at Fw, and the
permanent deformation D2, at Fstab, respectively, between the bottom and the top load application points as
follows:

where index X (X = AP-E, AP-F, ML) identifies the test loading condition involved (A-P extension, A-P flexion, M-L)
and index Y (Y = 6 , T) identifies the side of application of each set of end attachment within the test sample in the
test situation (6 for bottom and T for top).

NOTE For the example given in the note of 6.3.2.3.1, the designations/symbols of the deflection and the permanent
a deformation read D l , MUB and 0 2 ,MUB, respectively.

6.3.2.3.4 Do not use the sets of end attachment if the measured value of permanent deformation at Fstab
exceeds the following limit:

maximum permanent deformation at Fstab0 2 , = 1 rnm

6.32.3.5 Repeat 6.3.2.3.1 to 6.3.2.3.3 for two identical sets of end attachment to be connected to the opposite
end of the test sample for the application of the same test loading condition.

6.3.2.3.6 Do not use the sets of end attachment if the measured value of permanent deformation at Fstab
exceeds the following limit:

maximum permanent deformation at FstabD2,X/Y = 1 rnrn

6.3.2.3.7 Calculate the mean deflection D l , w,,,, at Fp, of the combination of a bottom and a top set of end
attachment to be used in the test sample for the application of the specific test loading condition as the mean of the
values of deflection calculated in 6.3.2.3.3 and 6.3.2.3.5:

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 6.3.2.3.8 Do not use the combination of bottom and top set of end attachments in the test sample for the
application of the specific test loading condition if the calculated value of mean deflection at Fw exceeds the
following limit:
Maximum mean deflection at Fpa D l , Xlmean = 2 mm

6.3.2.3.9 Record the results of the test, giving a cross-reference if earlier results are employed.

6.4 A-P and M-L test procedures

i 6.4.1 General

6.4.1.1 Conduct all A-P and M-I- tests with the components of the test sample set in the worst case alignment
position as specified in 5.5.3.

6.4.1.2 For all tests in the A-P flexion test loading condition, adjust the stride limiter with the hip unit in the fully
extended position. If this is not possible, adjust the stride limiter to minimum stride length (minimum hip flexion).

In order to avoid a stride limiter of specific design being 'pushed out' during the cyclic test due to the load line being
behind its pivot point, it may be necessary to alter the angle of the hip attachment plate to move the load line in
front of the pivot joint. Such modifications should be agreed between the manufacturer/submitter and the test
laboratory/ facility.

Record any modification(s) performed in the test report.

6.4.1.3 Carry out all M-L tests with the hip unit in the fully extended position.
NOTE An offset in the A-P plane, not exceeding 10 mm, may be used during the M-L test to apply an extension moment in
order to maintain the test sample in full extension.

Record the value of any offset in the A-P plane used in the test report.

6.4.2 Static A-P and M-L proof tests

NOTE 1 A test sample that has successfully completed the cyclic A-P or the cyclic M-L test procedure (including the final
static load test) may be used for the static A-P or the static M-L proof test, respectively, after realignment (see note 1 of 6.7).

NOTE 2 The measurements specified in 6.4.2.1 to 6.4.2.5 and 6.4.2.8 may be carried out with the test sample mounted
either in the test equipment or in a special jig which applies the stabilizing test force Fstab.

6.4.2.1 Prepare and align the test sample in accordance with clause 5 and the test submission document.
0
At zero load set the knee and hip offsets CftK, ftH, O'K and otH) and the test sample segment lengths
(litK- U'BK,u ' -~u ' and
~ U'TH - utH) in accordance with the values for the relevant test loading condition and test
loading level, specified in 7.2.1 and Table 3.

Measure and record

a) f 'K,f 'H, O'K and O'H,and

b) u ' -~upBK,u ' -~U'K and U'TH - 1 1 ' ~

6.4.2.2 Apply to the test sample the settling force Fset of the A-P and M-L test loading conditions at the
relevant test loading level, specified in Table 4.

Maintain this force, Fset, for a period between 10 s and 30 s, and then remove it.

Allow the sample to rest at zero load for a period of at least 15 min before proceeding with 6.4.2.3.

12 O I S 0 2000 - All riyhts reserved

 6.4.2.3 Apply to the test sample the stabilizing test force Fstab
specified in Table 4.

6.4.2.4 In accordance with the values for the relevant test loading condition and test loading level, specified in
Table 3, adjust the bottom and top load application levers until the knee and hip offsets (ftK, ftH, O'K and ofH) are
correct at the stabilizing test force Fstab.

6.4.2.5 Apply and maintain the stabilizing test force Fstab until the measurements specified below are
completed.

Measure and record

a) f 'K, f 'H. O'K,and O'H,

b) LK and LH,and

c) the distance LBK--rHas L4 or the displacement 60f the moving load application point (e.g. the cross-head) from
its reference position in the test equipment as 64.

8 NOTE If the measurements of a) and b) have been carried out with the test sample placed in a special jig, the stabilizing
test force Fstab has to be removed and re-appliedby the test equipment upon transfer of the test sample from the jig to the test
equipment before proceeding with c).

6.4.2.6 Increase the test force smoothly at a rate between 100 Nls and 250 N/s to the proof test force Fsp d
the A-P and M-L test loading conditions at the relevant test loading level, specified in Table 4.

Maintain this force, Fsp,at the prescribed value for 30 s.

6.4.2.7 Decrease the test force to Fstab.

6.4.2.8 Maintain the stabilizing test force Fstab= 50 N until the measurements specified below are completed.
Complete the measurements within 15 min.

Measure and record

a) the distance LBK-TH as L5 or the displacement Sof the moving load application point (e.g. the cross-head) from
its reference position in the test equipment as 65,

' b) f 'K, f '", O'K, o ' ~ and

.

c) LKand LH.

NOTE If the measurements of b) and c) are intended to be carried out with the test sample placed in a special jig, the
- stabilizing test force Fstabhas to be removed and re-applied by the jig upon transfer of the test sample from the test equipment
to the jig after having completed a).

6.4.2.9 Calculate and record the permanent deformation, D3, between the bottom and top load application
points:

6.4.2.10 If a permanent deformation D3 exceeding 15 m m occurs, the test sample does not satisfy the
requirements of the static A-P or M-L proof test of this International Standard.

6.4.2.11 If any individual component of the test sample fails to function safely after this test, record that this
component does not satisfy the requirements of the static A-P or M-L proof test of this International Standard in the
combination of components in the test sample.

@ I S 0 2000 - fill rights resewed

6.4.2.12 If the test sample fails, record the load at failure and the nature of the failure in the test report.

6.4.3 Static A-P and M-L failure tests

NOTE 1 A test sample that has successfully completed the static A-P or the static M-L proof test may be used for the static
A-P or the static M-L failure test, respectively, after realignment.

NOTE 2 The measurements specified in 6.4.3.1 to 6.4.3.5 may be carried out with the test sample mounted either in the test
equipment or in a special jig which applies the stabilizing test force Fstab.

6.4.3.1 Prepare and align the test sample in accordance with clause 5 and the test submission'document.

At zero load, set the knee and hip offsets (ffK, f ' ~O'K, and o f H ) and the test sample segment lengths
(utK- U'BK, U'H - U'K and U'TH - u f H ) in accordance with the values for the relevant test loading condition a ~ test
d
loading level, specified in 7.2.1 and Table 3.

Measure and record

a) f ' K , f ' H , O'K and O ' H , and

b) U'K - U'BK, UtH - U'K and 1ltTH - 1 1 ' ~ .

6.4.3.2 Apply to the test sample the settling force Fsetof the A-P and M-L test loading conditions at -ne
relevant test loading level, specified in Table 4.

Maintain this force, Fset,

for a period between 10 s and 30 s, and then remove it.

Allow the sample to rest at zero load for a period of at least 15 min before proceeding with 6.4.3.3.

6.4.3.3 Apply to the test sample the stabilizing test force Fstab
specified in Table 4.

6.4.3.4 In accordance with the values for the relevant test loading condition and test loading level, specified in
Table 3, adjust the bottom and top load application levers until the knee and hip offsets ( f ' ~ , O ' K and o f H ) are
fIH,

correct at the stabilizing test force Fst,b.

6.4.3.5 Apply and maintain the stabilizing test force Fstab until the measurements specified below are
completed.

Measure and record:

a) f ' K , f ' H , O ' K , and O'H

. .

b) LK and LH.

NOTE If the measurements of a) and b) have been carried out with the test sample placed in a special jig, the stabilizing
test force Fstab has to be removed and re-applied by the test equipment upon transfer of the test sample from the jig to the test
equipment before proceeding with 6.4.3.6.

6.4.3.6 Increase the test force smoothly at a rate between 100 Nls and 250 Nls until the test sample fails or
sustains the ultimate test force for brittle failure Fsu,brittle(see 6.4.3.7).

Record the maximum value of the test force F reached during the test.

6.4.3.7 The test force F which the test sample shall withstand in order to satisfy the requirements bf the static
A-P or M-L failure test of this International Standard is dependent upon the mode of failure that may occur (for
definition of mode of failure see 3.1, 3.2 and 3.3).

O I S 0 2000 - AII rigtris reserved

I
 The test sample shall satisfy the requirements of the static A-P or M-L failure test if it sustains the ultimate test
force for brittle failure Fsu,brittle,
or if ductile failure occurs at a load exceeding the ultimate test force for ductile
failure Fsu,dudle.

The values for Fsu of the A-P and M-L test loading conditions at the relevant test loading level are specified in
Table 4.

If expressly requested by the manufacturer/submitter, or if requested in the test submission document, the static
failure test may be continued after the test sample has withstood the test force specified in Table 4 for brittle failure
until failure actually occurs. In this case the attachments used need a higher value of stiffness, i.e. the values of
their deflection and permanent deformation must keep within the limits specified in 6.3.2 at a higher proof load than
is specified in Table 4.

6.4.3.8 If failure occurs, inspect the specimen to detect the mode of failure and record the results in the test
report.

6.4.4 Cyclic A-P and M-L tests

6.4.4.1 General requirements applicable t o cyclic A-P and M-L tests

4
6.4.4.1.1 The test equipment shall generate a single pulsating test force F: as shown in Figure 3, oscillating
through the range of cyclic test force Fc with an initial force Fminto generate a maximum test force F,,,, where

6.4.4.1.2 The waveform of the pulsating test force F generated by the test equipment shall be sinusoidal (see
Figure 3). If it is certified that a sinusoidal form is not possible, then the waveform shall be smooth with no
overshoot spikes.

Key
1 Test load F, Mu.
2 Time
3 Initial test load Fmi,, Muemin
9 4 Maximum test load
Fmax, Mu,max
5 Range of cyclic test load
Fcv Mu, c 2
Figure 3 - Load cycle parameters for cyclic tests

6.4.4.1.3 The test equipment shall switch off if the cyclic test force Fc deviates by more than 10 % of the
maximum test force Fma.

The test equipment control mechanism used to generate the sinusoidal waveform may require a number of cycles
to achieve the required waveform. During this settling-in period the waveform shall be smooth with no overshoot
spikes, and the maximum force applied shall not exceed the maximum test force Fmaxby more than 10 %.

6.4.4.1.4 The test equipment shall switch off if the deflection between the bottom and top load application points
PBKand PTHat Fmax increases by more than 5 mm from its initial value of deflection at Fma.

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The initial deflection measurement shall be made when the test equipment is running at the prescribed load with
the prescribed waveform (see 6.4.4.2.8 and 6.4.4.2.9).

6.4.4.1.5 If the test frequency selected is higher than 1 Hz, then the maximum frequency shall be below the level
at which dynamic mass effects begin to affect the maximum load value or the waveform.

6.4.4.1.6 During the course of the cyclic A-P and M-L tests, specified parts shall be replaced when the number
of cycles has reached a value at which such replacement is indicated in accordance with the manufacturer's1
submitter's service instructions andlor the test submission document. All such replacements shall be recorded in
the test report.

6.4.4.1.7 All test samples that successfully complete a cyclic test shall, at the request of the submitter, be
visually examined at x 4 magnification or greater, and the presence and nature of any cracks recorded in the test
report.

6.4.4.1.8 All test samples that successfully complete a cyclic test shall be subjected to a final static test force
Ff = Fsp (see 6.4.4.2.17).

6.4.4.2 Cyclic A-P and M-L test procedure

NOTE The measurements specified in 6.4.4.2.1 to 6.4.4.2.5 may be carried out with the test sample mounted either in the
test equipment or in a special jig which applies the stabilizing test force, Fstab, andlor the maximum test force, Fmax.

6.4.4.2.1 Prepare and align the test sample in accordance with clause 5 and the test submission document.

At zero load, set the knee and hip offsets V r K f, r H , O ' K and O'H) and the test sample segment lengths
( u ' -~I ~ ' B K
u ,' -~U'Kand 1 4 ' -~ u~ ' ~ in
) accordance with the values for the relevant test loading condition and test
loading level, specified in 7.2.1 and Table 3.

Measure and record

a) f ' K , f 'H, O'K and O'H, and

- --- - - - -
b) U'K - U'BK,u ' - ~ U'TH - U ' H ,
~ u ' and

6.4.4.2.2 Apply to the test sample the settling force FSet of the A-P and M-L test loading conditions at the
relevant test loading level, specified in Table 4.

Maintain this force, Fset, for a period between 10 s and 30 s, and then remove it. *
Allow the sample to rest at zero load for a period of at least 15 min before proceeding with 6.4.4.2.3.

6.4.4.2.3 Apply to the test sample the stabilizing test force Fstab specified in Tabie 4.

6.4.4.2.4 In accordance with the values for the relevant test loading condition and test loading level, specified in
Table 3, adjust the bottom and top application levers until the knee and hip offsets ( f t Kf, o t K ,and O ' H ) are correct
IH,

at the stabilizing test force Fstab.

6.4.4.2.5 Apply and maintain the stabilizing test force Fstab until the measurements specified below are
-completed.

Measure and record

b ) LK and LH,and

O I S 0 22uO - A:! lights reserved

1
 c) the distance L B ~as-L6~or~the displacement Sof the moving load application point (e.g. the cross-head) from
its reference position in the test equipment as 66.

NOTE If the measurements of a) and b) have been carried out with the test sample placed in a special jig, the stabilizing
test force Fstabhas to be removed and re-applied by the test equipment upon transfer of the test sample from the jig to the test
equipment before proceeding with c).

6.4.4.2.6 Apply to the test sample the maximum test force Fmax
of the A-P and M-L test loading conditions at the
relevant test loading level, specified in Table 4.

Maintain this force,,,,F

, until the measurements specified below are completed.

Measure and record

a) f ' K , f ' H , O'K and O'H,

b) LK and LH, and

' c) the distance LBK-TH as L7 or the displacement Sof the moving load application point (e.g. the cross-head) from
its reference position in the test equipment as 67.

NOTE If the measurements of a) and b) have been carried out with the test sample placed in a special jig, the maximum
test force Fm, has to be removed and re-applied by the test equipment upon transfer of the test sample from the jig to the test
equipment before proceeding with c).

6.4.4.2.7 Reduce the test force to the initial test force Fminspecified in Table 4.

6.4.4.2.8 Maintain the initial test force Fmin and apply the cyclic test force Fc of the A-P and M-L test loading
conditions at the relevant test loading level, specified in Table 4, at the frequency called for in the test submission
document for a series of cycles.

Do not proceed with 6.4.4.2.9 until the test sample and test equipment have settled down and achieved the
waveform specified in 6.4.4.1.2 with Fcnot deviating by more than 10 % .of, ,F

Stop the test equipment and record the number of cycles required to settle down in the test report.

NOTE The number of cycles required for the test to settle down will be determined by the nature of the test sample and the
4 test equipment control mechanism.

6.4.4.2.9 Apply to the test sample the maximum test force. , ,F Measure and record the initial value of the
distance LBK-TH as La or the displacement 6 of the moving load application point (e.g. the cross-head) from its
reference position in the test equipment as 613.

6.4.4.2.10 Reduce the test force to the initial test force.,F

i,

6.4.4.2.11 Maintain the initial test force Fminand apply the cyclic test force Fc of the A-P and M-L test loading
conditions at the relevant test loading level, specified in Table 4, for the number of cycles specified in Table 4 and
at the frequency called for in the test submission document.

Inspect the waveform of the applied cyclic test-force Fc. Terminate the test if the waveform does not comply with
6.4.4.1.2.

Set the test equipment displacement trip to 5 mm above the value of the initial displacement S8at,,F
, determined
in 6.4.4.2.9.

6.4.4.2.12 Examine the test sample for damage if the test equipment has switched off due to excessive
displacement.

9 ISC 2000 - All rlghts ressned 17

 If the test sample has failed, record that the test sample does not satisfy the requirements of the cyclic A-P or M-L
test of this lntemational Standard.

If there is no sign of failure, restart the test from 6.4.4.2.8 and apply the specified number of cycles reduced by the
number of cycles completed before the test equipment tripped.

6.4.4.2.13 Measure and record f 'K, f 'H,O'K and O'H, LK and LH as well as LBK-THor displacement 6 at F,i, and
F,, on the following occasions:

a) if the number of cycles of load has reached a value at which the exchange of specified parts is indicated in
accordance with the manufacturer's/submitter's service instructions andlor the test submission document (see
6.4.4.1.6);

d) when the specified number of cycles has been completed.

After the exchangelreplacement of specified parts, the test may be restarted from 6.4.4.2.1, 6.4.4.2.2 or 6.4.4.2.8,
depending on the mechanical properties of these parts and the complexity of the dis- and re-assembling of the test
sample necessary for their exchangelreplacement.

6.4.42.14 Record in the test report all occurrences of switch-off, the number of cycles of load applied up to that ()
time, the duration and the reason for switch-off.

6.4.42.15 Continue the test until failure occurs or the endurance (number of cycles in the test) specified in
Table 4 has been reached. In each case record the total number of cycles of load applied in the test report.

6.4.4.2.16 If a test sample fails, record the nature of failure in the test report.

6.4.4.2.17 In accordance with 6.4.4.1.8, subject all test samples that successfully complete a cyclic test to the
final static test force Ff = Fsp of the A-P and M-L test loading conditions at the relevant test loading level, specified
in Table 4, applied at a rate between 100 Nls and 250 Nls.

To pass the test, the load shall be maintained for 30 s without failure or gross deformation.

6.4.4.3 Failure criteria for cyclic A-P and M-L tests

6.4.4.3.1 If any one sample tested at a frequency of less than 3 Hz does not achieve the minimum endurance
specified in Table 4, the component is deemed not to satisfy the requirements of the cyclic A-P or M-L test of this
lntemational Standard.

6.4.4.3.2 If a sample tested at a frequency of 3 Hz or higher fails, then at least one further sample shall be
tested at less than 3 Hz in the same test loading condition and at the same test loading level. If any further sample
*
fails, the component is deemed not to satisfy the requirements of the cyclic A-P or M-L test of this International
Standard.

6.4.4.3.3 If a sample fails to sustain the final static force Ff = Fsp for a period of 30 s, the component is deemed
not to satisfy the requirements of the cyclic A-P or M-L test of this International Standard.
i
6.5 Torsional test procedures

6.5.1 General

Carry out the test in one direction of loading only. For asymmetrical test samples apply the torque in the direction
tending to rotate the knee internally relative to the hip.
%.

A hip extension moment may be applied in addition to the applied torque if this is necessary to maintain the
structural integrity of the test sample when the torque is applied. This should, however, be agreed between the
manufacturerlsubmitter and the test laboratorylfacility.

3 ISQ 2000 -All rights rsserved

 Record the application of a hip extension moment in the test report together with its approximate value.

6.59 Static torsional proof test

6.5.2.1 The manufacturer/submitter shall assemble the test sample in accordance with the manufacturer's
instructions, taking care in the tightening of bolts which clamp components together. The tightening torques of the
bolts shall be stated in the test submission document. All adjustable components shall be set in their midpositions.

The test laboratory/facility shall attach any fixtures necessary for mounting the test sample in the test equipment.
The tightening torques of any bolts shall be recorded in the test report.

6.5.2.2 Set up the test sample with the hip unit in full extension and with the effective knee- and hip-joint
centres aligned along the u'-axis.

6.5.2.3 Fix one end of the test sample and apply a twisting moment Mu, to the other end to generate the
settling torsional moment Mu*setspecified in Table 4.

for a period between 10 s and 30 s, and then remove it.

Maintain this moment, MUrset,

@ ~ l l othe
w sample to rest at zero load for a period of at least 15 min before proceeding with 6.5.2.4.

6.5.2.4 Apply to the test sample the twisting moment Mu#to generate the stabilizing torsional moment Af:, stab
specified in Table 4, and maintain it until the markings and readings of 6.5.2.5 are completed.

6.5.2.5 Mark the initial angular positions at the junctions of all parts.

Measure and record the initial angular positions relevant to twisting about the u'-axis of the bottom and top
components of the test sample Bbl and B t l respectively.

6.5.2.6 Increase the twisting moment MI,, smoothly at a rate not exceeding 4 Nmls to generate the torsional
proof moment Mu*sp specified in Table 4. Maintain the torsional proof moment for 30 s and then decrease it to the
stabilizing torsional moment Mulstab.

Note and record the time elapsed for testing.

6.5.2.7 Maintain the stabilizing torsional moment M,,lstabuntil the measurement specified below is completed.
Complete the measurement within 15 min.
9
Measure and record the final angular positions relevant to twisting about the 14'-axis of the bottom and top
components of the test sample 0b2 and Be respectively.

Note and record the time elapsed for measuring.

6.5.2.8 Calculate and record the relative angular movement about the ul-axis between the ends of the test
sample B r l as follows:

6.5.2.9 The test sample shall satisfy the requirements of the static torsional proof test of this International
Standard if the relative angular movement between the ends of the test sample B r l does not exceed 3", and the hip
unit continues to function safely.

If appropriate, use the marking of the initial angular positions at the junctions of all parts specified in 6.5.2.5 to
establish where and what amount of slippage has occurred.

-(9 I S 0 2000 - All reserved

ri~his
 6.5.3 Cyclic torsional test

6.5.3.1 General requirements applicable to the cyclic torsional test

6.5.3.1.1 The test equipment shall generate a single pulsating twisting moment Mu?oscillating through the range
Mu., with the initial twisting moment MUlmin
to generate a maximum twisting moment Mu#,,, where

6.5.3.1.2 The waveform of the pulsating twisting moment Mu.shall be sinusoidal (see Figure 3). If it is certified
that a sinusoidal form is not possible, then the waveform shall be smooth with no overshoot spikes.

6.5.3.1.3 The test equipment shall switch off if the cyclic twisting moment Mu*,deviates by more than 10 % of the
maximum twisting moment M,~,,.

The test equipment control mechanism used to generate the sinusoidal waveform may require a number of cycles
to achieve the required waveform. During this settling-in period the waveform shall be smooth with no overshoot
spikes, and the maximum twisting moment applied shall not exceed the maximum twisting moment Mu, by rnore,
,
than 10 %.

6.5.3.1.4 The test equipment shall switch off if the relative angular movement about the u'-axis betwee!. the
ends of the test sample at Mulm, increases by more than 3" from its initial value at Mu*,,,.

The value of initial relative angular movement shall be determined when the test equipment is running a: :he
prescribed load with the prescribed waveform (see 6.5.3.2.6 to 6.5.3.2.8).
I
I
6.5.3.1.5 If the test frequency selected is higher than 1 Hz, then the maximum frequency shall be below the avel
I
at which dynamic mass effects begin to affect the maximum load value or the waveform.

6.5.3.1.6 During the course of the cyclic torsional test, specified parts shall be replaced when the number of
cycles has reached a value at which such replacement is indicated in accordance with the manufacturer's/
submitter's service instructions andlor the test submission document. All such replacements shall be recorded in
the test report.

6.5.3.1.7 All test samples that successfully complete the cyclic torsional test shall, at the request of the
submitter, be visually examined at x 4 magnification or greater, and the presence and nature of any cracks
recorded in the test report.

6.5.3.1. 8 All test samples that successfully complete the cyclic torsional test shall be subjected to a final static
twisting moment Mulf= Mulsp(see 6.5.3.2.1 6).

6.5.3.2 Cyclic torsional test procedure

*
6.5.3.2.1 The manufacturer/submitter shall assemble the test sample in accordance with the manufacturer's
instructions, taking care in the tightening of bolts which clamp components together. The tightening torques of the
bolts shall be stated in the test submission document. All adjustable components shall be set in their rnidpositions.

The test laboratory/facility shall attach any fixtures necessary for mounting the test sample in the test equipment.
The tightening torques of any bolts shall be recorded in the test report.

6.5.3.2.2 Set up the test sample with the hip unit in full extension and with the effective knee- and hip-joint
centres aligned along the u'-axis.

6.5.3.2.3 Fix one end of the test sample and apply a twisting moment Mu. to the other end to generate the
settling torsional moment Mu,setspecified in Table 4.

Maintain this moment, for a period between 10 s and 30 s, and then remove it.

Allow the test sample to rest at zero load for a period of at least 15 min before proceeding with 6.5.3.2.4.

0 is0 2000 - All rights reserved

 6.5.3.2.4 Apply to the test sample the twisting moment Mu,to generate the stabilizing torsional moment Muestab
specified in Table 4, and maintain it until the markings and readings of 6.5.3.2.5 are completed.

6.5.3.2.5 Mark the initial angular positions at the junctions of all parts.

Measure and record the initial angular positions relevant to twisting about the u'-axis of the bottom and top
components of the test sample Bb3 and Bt3 respectively.

6.5.3.2.6 Apply to the test sample the initial twisting moment MUrmin specified in Table 4 and maintain it or
maintain the stabilizing twisting moment Munstab,respectively, and then apply the cyclic twisting moment Mu.,
specified in Table 4 at the frequency called for in the test submission document for a series of cycles.

Do not proceed with 6.5.3.2.7 until the test sample and test equipment have settled down and achieved the
waveform specified in 6.5.3.1.2 with Mu#,not deviating by more than 10 % of Mu#,,.

Stop the test equipment and record the number of cycles required to settle down in the test report.

NOTE The number of cycles required for the test to settle down will be determined by the nature of the test sample and the
Qst equipment control mechanism.
6.5.3.2.7 Apply to the test sample the maximum twisting moment Mu#,, specified in Table 4 and maintain it until
the measurement specified below is completed.

Measure and record the angular positions relevant to twisting about the 11'-axis of the bottom and top components
of the test sample 0 b4 and Ot4 respectively.

6.5.3.2.8 Calculate the initial relative angular movement at M,,,,,, about the u'-axis between the ends of the tes!
sample Or2 as follows:

6.5.3.2.9 Reduce the twisting moment MI,,to the initial twisting moment Mulminand maintain it.

6.5.3.2.10 Apply the cyclic twisting moment for the specified number of cycles at the frequency called for in the
test submission document. The value of MI,,, and the number of cycles ace specified in Table 4.

Inspect the waveform of the applied cyclic twisting moment M,,,,. Terminate the test if the waveform does not
'comply with 6.5.3.1.2.

Set the test equipment displacement trip to the value corresponding to a relative angular movement about the
u'-axis between the ends of the test sample of 3" greater than the value of the initial relative angular movement OQ
at M,,tmaxdetermined in 6.5.3.2.8.

6.5.3.2.11 Examine the test sample for damage if the test equipment has switched off due to excessive relative
angular movement (see 6.5.3.1.4).

If the test sample has failed, record that the test sample does not satisfy the requirements of the cyclic torsional test
of this International Standard.

If there is no sign of failure, restart the test from 6.5.3.2.6 and apply the specified number of cycles reduced by the
number of cycles completed before the test equipment tripped.

6.5.3.2.12 Measure and record the angular positions of the bottom and top components of the test sample Obmln
and Otmin respectively at MIlpmin / MUpstab,
and Obmax and OtmaX respectively at MllamaX,
and calculate and record the
related values of relative angular movement about the 11'-axis between the ends of the test sample 0, on the
occasions identified in a) and b) as follows:

" I S 0 2000 - kll , ~ g h t sreserved 21

i a) if the number of cycles of load has reached the value at which the exchange of parts is indicated in accordance
with the manufacturer's/submitter's service instructions andlor the test submission document (see 6.5.3.1.6);
, b) when the specified number of cycles has been completed.
I

NOTE After the exchangelreplacement of specified parts, the test may be restarted from 6.5.3.2.1, using the original
markings specified in 6.5.3.2.5for resetting up the test sample, from 6.5.3.2.3or from 6.5.3.2.6,depending on the mechanical
properties of these parts and the complexity of the dis- and re-assembling of the test sample necessary for their
exchangelreplacernent.

6.5.3.2.13 Record in the test report all occurrences of switch-off, the number of cycles of load applied up to that
time, the duration and the reason for switch-off.

6.5.3.2.14 Continue the test until failure occurs or the endurance (number of cycles in the test) specified in
Table 4 has been reached. In each case record the total number of cycles of load applied in the test report.

6.5.3.2.15 If a test sample fails, record the nature of failure in the test report.

6.5.3.2.16 In accordance with 6.5.3.1.8, subject all test samples that successfully complete the cyclic torsional
test to the final static twisting moment Mulf= MUnspspecified in Table 4, applied at a rate not exceeding 4 Nm/s and
i
I
in the same direction as the cyclic load which has been applied.

To pass the test, the load shall be maintained for 30 s without failure, or slippage at interfaces between adjacent
components of the test sample producing a permanent angular displacement greater than 3".

6.5.3.3 Failure criteria for cyclic torsional test

6.5.3.3.1 If calculation of relative angular moveme'nt on the occasion of any occurrence of switch-off shows that
slippage at the interface between adjacent components of the test sample has produced a permanent angular
displacement Bp, at MU*,in/ Mulstab of more than 3", the test sample is deemed not to satisfy the requirements of
the cyclic torsional test of this International Standard.

If appropriate, use the marking of the initial angular positions at the junctions of all parts specified in 5.5.3.2.5 to
establish where and what amount of slippage has occurred.

NOTE Opy is calculated as follows:

epy= (8b)rnin - e b 3 ) - (8tymin - @t3) or epy= (ebymin - etymin) - ( @ b 3- e t 3 )

8b3 and 813 are determined in 6.5.3.2.5and @bymin and Btymin are determined in 6.5.3.2.13.

6.5.3.3.2 If any one sample tested at a frequency of less than 3 Hz does not achieve the minimum endurance
specified in Table 4, the component is deemed not to satisfy the requirements of the cyclic torsional test of this
lnternational Standard.

6.5.3.3.3 If a sample tested at a frequency of 3 Hz or higher fails, then at least one further sample shall be
tested at less than 3 Hz. If any further sample fails, the component is deemed not to satisfy the requirements of the
cyclic torsional test of this International Standard.

6.5.3.3.4 If a sample fails to sustain the final static twisting moment M,,,f = Muvsp for a period of 30 s, the
component is deemed not to satisfy the requirements of the cyclic torsional test of this lnternational Standard.

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6.6 Number of tests required

The minimum number of tests required in order to claim compliance with this International Standard shall be as
shown in Table 1. All A-P and M-L tests shall be conducted in the worst case alignment position (see 5.5.3).

Table 1 - Required tests

Minimum number of tests required
Type of test Tests required for all hip units Supplementary tests required for
hip units with a stride limiter
Static proof test 1 test in A-P extension 1 test in A-P flexion
and
1 test in M-L

Static failure test 1 test in A-P extension 1 test in A-P flexion

and
1 test in M-L

Cyclic test 1 test in A-P extension 1 test in A-P flexion

and
1 test in M-L

Static torsion test 1 test

Cyclic torsion test 1 test

6.7 Restrictions on multiple use of test samples

Test samples that have been subjected to A-P test loading conditions shall not be subjected to M-L iest loading
conditions or vice versa.

Test samples which have been subjected to the static proof test or the static failure test shall not be used for the
cyclic test (but see note 1).

NOTE 1 Test samples which have successfully completed the cyclic test procedure (including the final static load test) may
be used for the static proof test or the static failure test after realignment.
8
NOTE 2 For hip units with a stride limiter, a test sample which has satisfied the requirements for the A-P extension test may
be used for the A-P flexion test.

6.8 Accuracy

6.8.1 The test equipment (see 3.4) and any jig used for alignment andlor measurement shall be calibrated at
least annually and records of the calibration maintained.

6.8.2 The test equipment and any jig used for alignment andlor measurement under load shall measure the
highest load to be applied to an accuracy of within 1 Oh.+
6.8.3 The test equipment and any jig used for alignment and/or measurement shall measure linear and/or
angular dimensions to an accuracy of within ? 0,l mm or ? 0 , l 0 ,respectively.

6.8.4 For the cyclic tests, the test equipment shall control the frequency of test to an accuracy of within + 10 %.
6.8.5 Linear dimensions shall be set with a tolerance of * 1 mm.
6.8.6 Angular dimensions shall be set with a tolerance of k 1"

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O rights reserved
7 Test loading parameters

7.1 Test loads and references

All relevant test loads are listed in Table 2 together with references to the specific subclauses and tables of this
International Standard.

Table 2 -Test loads and references

References
Test load
Subclause Table
Stabilizing test force 6.3.2; 6.4.2; 6.4.3; 6.4.4.2 4
Fstab = 50 N
Settling test force 6.3.2; 6.4.2; 6.4.3; 6.4.4.2 4
Fset = 0,8 x Fc
Static proof test force of proof test of end 6.3.2 4
attachments
Fpa = 1~2 Fsu,brittle
Static proof test force 6.4.2; 6.4.4.1; 6.4.4.2; 6.4.4.3 4
Fsp = 1.75 x Fc
Static failure test force 6.4.3 4
- ductile: Fs, = 1,5 x Fsp
- brittle: Fsu = 2,O x Fsp
Initial test force 6.4.4.1 ; 6.4.4.2 4
Fmin = 50 N
Cyclic test force 6.4.4.1; 6.4.4.2 4
Fc
Maximum cyclic test force 6.4.4.1; 6.4.4.2 4
Fmax = Fmin + Fc
Stabilizing twisting moment 6.5.2; 6.5.3.2 4
Munstab = 1 Nm
Settling twisting moment 6.5.2; 6.5.3.2 4
Mufset = 3 Nm
Static proof twisting moment 6.5.2; 6.5.3.1; 6.5.3.2; 6.5.3.3 4
Mu1sp
Initial twisting moment 6.5.3.1; 6.5.3.2 4
MUlmin= 1 Nm
-
Cyclic twisting moment 6.5.3.1 ; 6.5.3.2 4
Mu-,
Maximum cyclic twisting moment 6.5.3.1 ; 6.5.3.2 4
Mu~rnax= Muernin + Mupc

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1
 7.2 Details of loading

7.2.1 Length of test sample

The length of the test samples is determined by the following relationships:

NOTE For the different u'-levels, see clause 4 and Figure 1.

7.2.2 Load reference points, offsets and effective lever arms

The f '- and 0'-coordinates (offsets) of the load reference points on the bottom, knee, hip and top refere~ceplanes
and the effective lever arms for the A-P and M-L test loading conditions at the different test loading I e w i s shall be
*n accordance with Table 3.

9 I S 0 2000 - WI rights reserved

 Table 3 - Configurations for A-P and M-L tests
Type of test Reference Reference off sets2) Effective
plane centre lever arms'). 2)
mm mm

A-P extension Bottom PBK f 'BK = 1 0 4 3, O*BK = 0 3)

Knee PK f ' K = 67 ovK=0 LK= 63

o Hip PH f ' H =-83 OIH =O LH= 78

z TOP PTH f 'TH = -1 59 3) O ~ =H0 3)
a
- 3) O'BK = 0 3)
A-P flexion Bottom PBK f 'BK = -7
>
-
w Knee PK f'~=0 O'K = 0 &=O
WJ
c
Hip PH f ' H = 29 ofH= 0 LH= 29
=E
Q 3) = 0 3)
-
o
c.
TOP PTH f 'TH = 43 O'TH

M-L f 1 B K = o 3, o r B K = -37 3)
e ~ottom
Knee
PBK
PK ftK=O OIK = -47 LK= 47
Hip PH f'~=0 OIH = -86 LH= 86
~ ' T=
H0 3, OITH = -1 06 3)
TOP PTH
A-P extension Bottom PBK f t ~ ~ = 1 13)5 o l g=
~ 0 3)
Knee PK f ' K = 75 otK= 0 LK= 70

0
Hip PH f IH = -84 O'H = 0 I L~=78
00
TOP PTH f 'TH = -1 63 3) OITH = 0 3)
a
- A-P flexion Bottom f IeK =-9 3) o V B K = o 3,
9a,
-
PBK
Knee PK f r ~ = O OIK =O LK= 0
m
C
5 Hip PH f ' H = 35 ofH= 0 LH= 35
-
(II
0
M .
TOP PTH f l T H = 53 3, o r T H =o 3)

z f l B K = o 3,
V)
M-L ~ottom PBK oeBK =-49 3)
Knee PK fl~=O orK = -57 LK= 57
Hip h i . f f ~ = O =-91
O ~ H LH= 90
TOP PTH ~ ' T=H 0 3, O ~ T H= -1 08 3)
A-P extension Bottom PBK f f ~ ~ = 1 13)6 OIBK = 0 3)
Knee PK frK=77 ofK =o LK= 72
Hip PH f ' H = -76 ofH= 0 LH= 7 1
0
(D
f 'TH = -1 53 3) O'TH = 0 3)
- -
a TOP PTH
a,
> A-P flexion Bottom PBK f ' B K = -1 0 3) O'BK = 0 3)
-
a
Knee PK f l ~ = O O'K =0 LK=O
0
.-C f ' H = 41 =0 LH= 4 1
u Hip PH OIH
Q
-
0
C
TOP PTH f 'TH = 62 3) O'TH = 0 3)

z
U)
M-L Bottom PBK f IBK = 0 3, O'BK = -63 3)
Knee PK fIK=O O'K = -67 LK= 67
Hip PH f l ~ = O O'H = -83 LH= 83
TOP PTH ~ ' T= H 0 3, O'TH = -92 3)
1) For 'offset' and 'effective lever arm' see 4.7.1 and 4.7.2.
The given values are rounded to the integer mm - values nearest to the exact values calculated from the relevant
components of loading acting on the effectiveknee and hip joint centre (see also Annex 8).
3) Offsets in the bottom and top reference planes are only for guidance in aligning test samples.

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-.
7.2.3 Test loads and endurance

The test loads and endurance for the A-P, M-L and torsional test loading conditions at the different test loading
levels shall be in accordance with Table 4.

Table 4 - Test loads and endurance

Test load

Type of test Symbol Value for

level level level

A1 00 A 80 A 60

A-P and M-L loading condition

Proof test of end attachments F ~ a 5 376 N 4410 N 3 780 N

All tests Fstab 50 N 50 N 50 N

Fset 1 024 N 840 N 720 N

Static tests 2 240 N 1 838 N 1 575 N

FSP
3 360 N 2 756 N 2 363 N
Fsu,ductile
4 480 N 3 675 N 3 150 N
Fsu,brittle

Cyclic test 50 N 50 N 50 N
Fmin 1 280 N 1 050 N 900 N
Number of cycles: 2 r 1o6
Fc 1 330 N 1 100 N 950 N
Fmax

Torsional loading condition

All tests Mu'stab 1 Nm

Mu'set 3 Nm

Static torsional test Mulsp 50 Nm

Cyclic torsional test 1 Nm

M,,~rnl"
Number of cycles: 2 x lo6 30 Nm
MUec
31 Nm
Mu-rnax

8 Test submission document

8.1 Document need

The test submission document shall accompany each item submitted for testing in accordance with clauses 5, 6
and 7. It shall provide the information specified in 8.2 to 8.4.

8.2 General requirements

8.2.1 The rnanufacturer/subrnitter shall prepare the test submission document with any associated information
and shall provide at least one copy with every item submitted for test.

-
ccj I S 0 2000 - All rights reserved
8.2.2 The manufacturer/submitter shall clearly indicate a name and address for communication purposes. If
appropriate, the identity of the original equipment manufacturer shall be provided.

8.2.3 A unique and traceable identification for the test submission document shall be provided by the
manufacturer/submitter who shall maintain a record of such identification. This identification shall also be applied to
the test sample.

8.2.4 The test laboratory/facility required to conduct the test shall be clearly indicated.

8.2.5 The date of submission or dispatch to the test laboratoryffacility shall be clearly indicated.

8.3 lnformation required for test samples

8.3.1 All test samples

The following information, attributable to a fully traceable identification for each test sample, shall be included in the
test submission document:

a) manufacturer's name or other means of identification (for each compcnent if a test sample consists of part?
from different manufacturers);

b) manufacturer's model identification name andlor number (for each component if a test sample consists of parts
from different manufacturers);

c) type of test sample in accordance with 5.1;

d) if appropriate, any certifications from the manufacturer which states that the test sample has been taken from
normal production and which gives details of the method of selection in accordance with 5.3;

e) identification of effective centrelines and effective centres in accordance with 5.2.2 and 5.5.2;

f) record of any load application levers and their static alignment in accordance with 5.2.4;

g) any special alignment instructions for the test sample and/or attachments in accordance with 5.2.5;

h) tightening torque settings for connecting bolts (particularly applicable to test samples for torsional tests in
accordance with 6.5.2.1 and 6.5.3.2.1 ).

8.3.2 Test samples for all A-P and M-L tests 4b

Identification of the worst-case alignment position in accordance with 5.5.3.

8.4 lnformation required for tests

8.4.1 General

For each test sample, the information specified in 8.4.2 to 8.4.6 shall be included in the test submission document.

8.4.2 For all tests

Specify

a) the particular test requested, with reference to the relevant subclauses of clauses 6 and 7;

b) the particular set-up dimensions and the loads to be applied during the test in accordance with 6.3.1 and
clause 7.

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8.4.3 For all A-P and M-L tests

Specify the worst-case alignment position in accordance with 6.4.1.I.

8.4.4 For all torsional tests

Specify identification of the midpositions of all adjustable components in accordance with 6.5.2.1.

8.4.5 For all cyclic tests

Specify

a) replacement intervals of specified parts in accordance with 6.4.4.1.6and 6.5.3.1.6;

b) if appropriate, request for visual examination of the test sample after successful completion of the cyclic test in
accordance with 6.4.4.1.7and 6.5.3.1.7;

c) the test frequency called for in accordance with 6.4.4.2.1

1 and 6.5.3.2.1
1

64.6 For A-P and M-L static failure tests

If appropriate, request for continuation of the test until failure actually occurs in accordance with the last paragraph
of 6.4.3.7.This request shall include instructions concerning the documentation of test results.

9 Test report

9.1 General requirements

9.1.1 The test laboratorylfacility shall prepare a test report for each test conducted and shall provide at least one
copy to the submitter of the test sample.

9.1.2 The test laboratorylfacility shall clearly indicate a name and address for communication purposes.

9.1.3 The test laboratorylfacility shall provide a unique and traceable identification for the test report (such as
serial number) including identification of each page, and information of total number of pages of the report. The test
laboratorylfacility shall maintain a record of such identification.

3.1.4 The submitter of the test sample and the test laboratorylfacility identification shall be clearly indicated.

9.1.5 The test report shall be signed on behalf of the test laboratorylfacility by a designated person.

9.1.6 The date(s) of receipt of test samples and the date(s) of preparation of the test report shall be clearly
indicated.

9.1.7 All records called for in the relevant subclauses of clause 6 shall be copied into the test report.

9.2 Records required for all test samples

The following information for each test sample shall be included in the test report:

a) fully traceable identification for each sample tested. If the sample has no permanent identification mark, the
test laboratory/facilityshall affix one after the testltests haslhave been completed;

b) the type of sample in accordance with 5.1 ;

c) the load application levers used in accordance with 5.2.4;

"' ;SO29CO - All rights reserved

d) the alignment of the sample in accordance with 5.2.4, 5.2.6 and 5.5;

e) tightening torque settings for connecting bolts (particularly applicable to test samples for torsional tests in
accordance with 6.5.2.1 and 6.5.3.2.1).

9.3 Records required for all tests

The following informationfor each test sample shall be included in the test report:

a) the particular test carried out in accordance with the relevant subclauses of clauses 6 and 7. In special cases
reference to the test submission document will be necessary;

b) the particular set-up dimensions and the loads applied during the test in accordance with 6.3.1 and clause 7;

C) proof test of attachments (if required) in accordance with 6.3.2;

d) any particular arrangement in accordance with the second paragraph of 6.4.1.2 and the notes tcilowing
6.4.1.3. 6.4.4.2.8 andlor 6.5.3.2.6;

e) accuracy of test equipment and individual measurements in accordance with 6.8. a

9.4 Records required for results of A-P and M-L tests

9.4.1 General

For each test sample, the informaiion specified in 9.4.2 to 9.4.4 shall be included in the test report.

9.4.2 Results of static A-P and M-L proof tests

Include records of

a) measurements of offsets, effective lever arms, and lengths or displacements in accordance with 6.4.2.1,
6.4.2.5 and 6.4.2.8 and calculation of deformation in accordance with 6.4.2.9;

b) examinationhnspectionof function in accordance with 6.4.2.1 1;

c) load at, and nature of, any failure in accordance with 6.4.2.1 2.

9.4.3 Results of static A-P and M-L failure tests

Include records of

a) measurements of offsets and effective lever arms in accordance with 6.4.3.1 and 6.4.3.5;

b) the ultimate test force Fsu in accordance with 6.4.3.6 and 6.4.3.7;

c) at the request of the manufacturer/subminer-results of the continuation of test until failure actually occurs in
accordance with the last paragraph of 6.4.3.7;
. .-.
d) the mode of failure in accordance w~th6.4.3.8. i

9.4.4 Results of cyclic A-P and M-L tests

I
lnclude records of

a) measurements of offsets, effective lever arms, and lengths or displacements in accordance with 6.4.4.2.1.
6.4.4.2.5, 6.4.4.2.6,6.4.4.2.9 and 6.4.4.2.13;

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A '
 b) the number of cycles for the test to settle down in accordance with 6.4.4.2.8.
c) the test frequency in accordance with 6.4.4.2.1 1;
d) the details of all switch-off occurrences in accordance with 6.4.4.2.14;
e) the replacement parts in accordance with 6.4.4.1.6;
f) the number of cycles at failure or the endurance in accordance with 6.4.4.2.15;
g) the nature of any failure in accordance with 6.4.4.2.16;
h) at the request of the manufacturer/submitter, the presence and nature of any cracks detected by visual
examination in accordance with 6.4.4.1.7;

i) results of the final static test to proof loading level in accordance with 6.4.4.1.8 and 6.4.4.2.17.

9.5 Records required for results of torsional tests

9.5.1 Inclusion of records

fie following information for each test sample shall be included in the test report.
. -
9.5.2 Results of static torsional test

Include records of

a) the tightening torque of any joint-clamping bolts in accordance with 6.5.2.1;

b) measurements of the initial and final angular positions of the bottom and top components of the test sample in
accordance with 6.5.2.5 or 6.5.2.7, respectively;

c) the time elapsed tor testing and for measuring the final angular positions of the bottom and top components of
the test sample in accordance with 6.5.2.6 and 6.5.2.7;

d) calculation of the relative angular movement between the ends of the test sample in accordance with 6.5.2.8.

9.5.3 Results of cyclic torsional test

Include records of

the tightening torque of any joint-clamping bolts in accordance with 6.5.2.1;

v
b) measurements of angular positions of the bottom and top components of the test sample in accordance with
6.5.3.2.5, 6.5.3.2.7 and 6.5.3.2.12;

c) calculation of the relative angular movement between the ends of the test sample in accordance with 6.5.3.2.8
and 6.5.3.2.12;

d) the number of cycles for the test to settle down in accordance with 6.5.3.2.6;
e) the test frequency in accordance with 6.5.3.2.10;
f) the details of all switch-off occurrences in accordance with 6.5.3.2.1 3;

g) the replacement of specified parts in accordance with 6.5.3.1.6;

h) the number of cycles at failure or the endurance in accordance with 6.5.3.2.14;

i) the nature of any failure in accordance with 6.5.3.2.15;

1) at the request of the manufacturer/submitter, the presence and nature of any cracks detected by visual
examination in accordance with 6.5.3.1.7;
k) results of the final static test to proof loading level in accordance with 6.5.3.1.8 and 6.5.3.2.1 6.

(rJ ISG 2000 - All rights reserved

 Annex A
(normative)

Description of internal loads and their effects

A1 General
The test loading conditions specified in this International Standard are based on internal reference loads consisting
of an axial force (axial compression), bending moments and a twisting moment described in A.3.
The reference forces and moments act respectively along and about reference lines. The moment reference lines
are specified in A.2.

A.2 Moment reference lines

A2.1 General

The moment reference lines are those lines about which the moments specified in A.3 act. They are specified as
follows using the elements of the geometric system described in clause 4.

A.2.2 Knee moment reference lines

A.2.2.1 The knee moment reference line Kf is the line of intersection of the knee reference plane (K) with the
f '-ur-plane.

A.2.2.2 The knee moment ref&ence line KO#is the line of intersection of the knee reference plane (K) with the
0'-u'-plane.

A.2.3 Hip moment reference lines

A.2.3.1 . The hip moment reference line Hfl is the line of intersection of the hip reference plane (H) with the
f '+'-plane.

A.2.3.2 The hip moment reference line Ho1 is the line of intersection of the hip reference plane (H) with the
0

A.3 Internal loads

A3.1 General - --- - - - - --

The internal forces and moments are indicated in the following subclauses, together with anatomical descriptions of
their effects. Table A . l contains a list of these, together with alternative descriptions for the movements which
positive forces and-moments tend to cause.

For a left-sided application, the axial force, all bending moments and the twisting moment M,,. are positive as
illustrated in Figure A.1.

For a right-sided application, the mirror image applies (see 4.1 and Figure 1). As a consequence the bending
moments MKf,,MH and the twisting moment Mu.are positive in the opposite direction (see Figure A.l).

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- ._-
Key
1 Top reference plane, TH
2 Hip reference plane, H
3 Knee reference plane, K
4 Bottom reference plane, BK
Hip moment reference line
6 Effective hip joint centre
7 Effective knee joint centre
8 Knee moment reference line
a Right
b Left

Figure A.l - Coordinate system according to 4.2, illustrating positive directions of internal (reaction)
loads, comprising axial force F,,, and bending moments MK,,*,MK ,, MHoland MHf generated in the upper
I,

(proximal) part of the test piece by the lower (distal) part through the load actions applied in the bottom
reference plane

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L
A3.2 Axial force F,. (axial compression)
The axial force F,I is the force component along the u'-axis of the coordinate system according to 4.2. Positive F,,,
tends to compress the thigh segment of the hip disarticulation prosthesis in its longitudinal direction.

113.3 Moments
A.3.3.1 Knee bending moment, MK,.
The knee bending moment MKn*is the moment about the knee moment reference line KO..Positive MK,* tends to
cause extension at the knee joint.

A.3.3.2 Knee bending moment, MK 1

The knee bending moment MK is the moment about the knee moment reference line K
1 1. Positive MK tends to
cause a lateral movement of the knee relative to the hip.

A.3.3.3 Hip bending moment, MH,,

The hip bending moment MH,l is the moment about the hip moment reference line H,,l. Positive MH,. tends to caua
flexion at the hip joint.

A.3.3.4 Hip bending moment, MH 1

The hip bending moment MHf~ is the moment about the hip moment reference line Hfe. Positive MH f r tends to
cause adduction at the hip joint.

A.3.3.5 Twisting moment (torque), Mul

The twisting moment M,,, is the moment about the u'-axis of the coordinate system according to 4.2. Positive Mu.
tends to cause internal rotation of the distal end of the thigh segment of the hip disarticulation prosthesis relative to
the proximal end.

Table A.l - Positive internal force and moments with descriptions of their effects
Internal load Anatomical description Alternative description

Positive load tends t o .

Axial force Fur compress the thigh in its longitudinal direction

Knee moment MK~, cause extension at the knee joint straighten the knee
Knee moment MK~, cause a lateral movement at the move the knee in an outward
knee relative to the hip direction relative to the hip
Hip moment M H ~ cause flexion at the hip joint move the thigh in a forward
direction
Hip moment MH~' cause adduction at the hip joint move the thigh in an inward
direction
Twisting moment Mu, cause internal rotation of the distal twist the thigh to turn the front side
end of the thigh relative to the of the knee inwards
proximal end

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 Annex B
(informative)

Reference data for the specification of the A-P, M-L and torsional test
loading conditions at different test loading levels

B.l Background statement on test loading levels

Since the start of the work by IS0 Technical Committee ISOfrC 168, some countries have esta6iished an sdverse
event reporting system. At the time of publication, this has shown a low field failure rate assdated w,tk. Test~ng,
based on the data of all users, to a single test loading level.

The test loading level A100 according to the categorization of 6.2.3 is based on this single test%ading It-vel and,
dditionally, on a statistical analysis of data included in the final report of a recent internati~nat~st~ay
cclcerned
6 th the acquisition of loads exerted on hip disarticulation prostheses by amputees during daily-use J-I ir - :nr and
outdoor environment (see the Bibliography).

Test loading levels A80 and A60 according to the categorization of 6.2.3 are based on a statistical anal: : 5 ~f the
data referred to in the foregoing paragraph and require validation by field experience.

B.2 Specification of the A-P, M-L and torsional test loading conditions
The data referred to in clause B.l establishes the basis from which to specify the parameters and values fcr the
A-P, M-L and torsional test loading conditions at the different test loading levels according to the categorization of
6.2.3.

Table B.l contains the values of the knee and hip bending moments M K and MH as specified in annex A and the
test force F for the A-P and M-L test loading conditions.

Table.B.2 contains the values of the twisting moment M,,,.

able B.3 gives formulae for calculating the axial force Fulas specified in annex A from given values of test force F,
6 ee and hip bending moments M K and MH and distance u ' -~ u ' ~ .

Table B.4 gives formulae for calculating effective lever arms and offsets from given values of test force F, axial
and knee and hip bending moments M K and M H .
force Fue

Table B.5 gives formulae for calculating offsets at any height (see Table 3).

@ I S 0 2000 - All rights resered

L___
 - -
n,n - H,n aaueas!p pue Hjq pue XW saualuolu 6u!puaq
d!y pue aauy 'J aaloj Jsaa l osanleA u a ~ ! 6luo.t4 and amol le!xe aqa 6u!aelnsle3 JOJ aelnunoj -g.9 q q e l
SL 0 0 09 V
96 0 0 08 V
01 L 0 0 001 V UN ./HW luaurow 6u!puaq d ! ~
09 0 0 09 V
09 0 0 08 V
09 0 0 001 V UN 'JYW iuauour 6u!puaq aauy
0 LE t9- 09 V
0 LE Z8- 08 V
0 LE 00 L- 001 V w~ dOHw guauour Gu!puaq d ! ~
0 0 S9 09 V
0 0 EL 08 V
0 0 08 001 V w~ a " + v luaurow Bu!puaq aauy
006 006 006 09 V
OSO 1 OSO 1 OSO 1 08 V
08Z 1 082 1 082 1 001 V N d a3104 pal
uo!xalj uo!suasxa
1-W d-V d-V
(anal
I
P ~ Oasal pe01asal
suo!a!puoa 6u!peol asal
suo!a!puoa 6u!peol
ssaa 1-yy pue d-v lo) d a a ~ oasaj
j pue Hw pue sgualuow 6u!puaq d!y pue aauy 40 sanleA - 1-8alqel
0~1
( 3 ) 0 0 0 ~ : ~ &OSI
 Table 8.4 - Formulae for calculating effective lever arms and offsets from given values of test force F,
axial force Funand knee and hip bending moments MKand MH

Level A-P test loading conditions M-L test loading conditions

effective lever arms offsets effective lever arms offsets

mm mm mm mm

Knee LK=-M K ~ f t MK, M K ~ ~ &=-MKf'

K -
F Fun LK= F I$#

Hip L H = -M H ~ ' f,i =-Mtio' MH/'

LH=- 4 =-MHfl
F Fu* F Fu,

Table B.5 - Formulae for calculating offsets at any height, u,

IA-P extension test loading condition

IA-P flexion test loading condition

I M-L test loading condition

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L,
 Bibliography

I S 0 10328-1:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 1: Test configurations.

I S 0 10328-2:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 2: Test samples.

I S 0 10328-3:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 3: Test methods of

principal structural tests.

I S 0 10328-4:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 4: Test loading

parameters of principal structural tests.

I S 0 10328-51996, Prosthetics - Structural testing of lower-limb prostheses - Part 5: Test methods of

supplementary structural tests.

I S 0 10328-6:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 6: Test loading

parameters of supplementary structural tests.
0
I S 0 10328-7:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 7: Test submission
document.

I S 0 10328-8:1996, Prosthetics - Structural testing of lower-limb prostheses - Part 8: Test report.

Nietert, M. et a/.: International study on the acquisition of loads in hip disarticulation prostheses - Final
report on item P2 of the mandated programme of laboratory tests in support of the European Standard
EN 12523 "External limb prostheses and external orthoses - Requirements and test methods"; Giessen,
March 1997 - (Prof. Dr.-lng. Manfred Nietert, Fachhochschule Giessen-Friedberg, Biomechanik-Labor,
Wiesenstrasse 14, D-35390 GiessenIGermany)

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- -4ld