INTERNATIONAL ISO

STANDARD 1 42 42 -2

Second edition
2016-09-15

Implants for surgery — Wear of total

hip-j oint prostheses —

Part 2:
Methods of measurement

Implants chirurgicaux — Usure des prothèses totales de l’articulation

de la hanche —

Partie 2: Méthodes de mesure

Reference number
ISO 14242-2:2016(E)

© ISO 2016
ISO 1 42 42 -2 : 2 01 6(E)

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ii © ISO 2016 – All rights reserved

 ISO 1 42 42 -2 : 2 01 6(E)

Contents Page

Foreword ........................................................................................................................................................................................................................................ iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative reference ......................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Gravimetric method .......................................................................................................................................................................................... 1
4.1 Principle ........................................................................................................................................................................................................ 1
4.2 Reagents and materials ................................................................................................................................................................... 1
4.3 Apparatus .................................................................................................................................................................................................... 2
4.4 Preparation of test specimen for gravimetric measurements ....................................................................... 2
4.5 Procedure for gravimetric measurement......................................................................................................................... 3
5 Dimensional change method ................................................................................................................................................................... 3
5.1 Principle ........................................................................................................................................................................................................ 3
5.2 Apparatus .................................................................................................................................................................................................... 3
5.3 Procedure for dimensional change measurement ................................................................................................... 4
6 Test report ................................................................................................................................................................................................................... 4

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ISO 1 42 42 -2 : 2 01 6(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work o f preparing International Standards is normally carried out
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assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary in formation
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.

This second edition cancels and replaces the first edition (ISO 14242-2:2000), o f which it constitutes a
minor revision.
ISO 14242 consists of the following parts, under the general title Implants for surgery — Wear of total
hip-joint prostheses:

— Part 1 : Loading and displacement parameters for wear-testing machines and corresponding
environmental condition s for test

— Part 2: Methods of measurement

— Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and
corresponding environmental condition s for test

iv © ISO 2016 – All rights reserved

INTERNATIONAL STANDARD ISO 1 42 42 -2 : 2 01 6(E)

Implants for surgery — Wear of total hip-j oint

prostheses —

Part 2 :
Methods of measurement

1 Scope

This part o f ISO 14242 specifies methods o f assessment o f wear o f the acetabular component o f total
hip-joint prostheses using gravimetric techniques and changes in dimensional form o f components
tes ted in accordance with I SO 142 42 -1 or I SO 142 42 -3 as appropriate.

NO TE S ome i nves tigators have exp erienced problem s with organic dep o s its affec ti ng the res u lts of

measurements, especially with hard/hard combinations. No specific precautions are included in this part o f
I S O 142 42 , but cle ani ng tech n iques adop te d i s intended to b e s uitable for the s oi l s pro duced .

2 Normative reference

The following documents, in whole or in part, are normatively re ferenced in this document and are
indispensable for its application. For dated re ferences, only the edition cited applies. For undated
re ferences, the latest edition o f the re ferenced document (including any amendments) applies.
I S O 142 42 -1 , Implants for surgery — Wear of total hip-joint prostheses — Part 1 : Loading and displacement
parameters for wear-testing machines and corresponding environmental condition s for test

I S O 142 42 -3 , Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement
parameters for orbital bearing type wear testing machines and corresponding environmental condition s
for test

3 Terms and definitions

For the purposes o f this document, the following terms and definitions apply.
3 .1
wear
material loss from components o f the prosthetic joint due to combined movement and loading

4 Gravimetric method

4.1 Principle

The test specimen is soaked in a lubricant. It is repeatedly removed from the lubricant, cleaned, dried and
weighed until a steady rate o f fluid sorption is established. The test specimen is assessed subsequently
for wear by testing for loss in mass in a knee-hip simulator. A loaded, non-articulating control specimen
is intended to allow for fluid sorption and undergoes the same procedure for re ference purposes.

4.2 Reagents and materials

4.2 .1 Fluid test medium , in accordance with I SO 1 42 42 -1 or I SO 1 42 42 -3 as ap prop riate.

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ISO 1 42 42 -2 : 2 01 6(E)

4.2 .2 Control specimen , in accordance with ISO 14242-1 or ISO 14242-3 as appropriate.
4.2 .3 Propan-2 -ol .
4.3 Apparatus

4.3 .1 Balance , with an accuracy o f ±0,1 mg, o f sufficient capacity for the mass o f the test specimen.

4.3 .2 Ultrasonic cleaner.

4.3 .3 Vacuum drying system , capable of achieving a vacuum of at least 13,33 Pa.
4.3 .4 Filtered inert-gas j et , e.g. nitrogen.
4.4 Preparation of test specimen for gravimetric measurements

4.4.1 Soak the test specimen and control specimen in the fluid test medium (4.2.1 ) for 48 h ± 4 h.

4.4.2 Remove the test specimen and control specimen from the fluid test medium (4.2.1) and clean in
the ultrasonic cleaner (4.3.2).
A typical cleaning regime in the ultrasonic cleaner is as follows:
a) vibrate for 10 min in deionized water;
b) rinse in deionized water;
c) vibrate for 10 min in a mixture of ultrasonic cleaning detergent in deionized water at the
concentration recommended by the detergent manu facturer;
d) rinse in deionized water;
e) vibrate for 10 min in deionized water;
f) rinse in deionized water;
g) vibrate for 3 min in deionized water;
h) rinse in deionized water;
i) dry in a vacuum drying chamber (4.3.3).
Care should be taken to avoid abrasion in the ultrasonic cleaner which could lead to change in mass.
4.4.3 Dry the test specimen and control specimen with a jet o f filtered inert gas (4.3.4).

4.4.4 Soak the test specimen and control specimen in propan-2-ol (4.2.3 ) for 5 min ± 15 s.
4.4.5 Dry the test specimen and control specimen with a jet o f filtered inert gas (4.3.4 ), then dry further
in a vacuum o f better than 13,3 Pa ± 0,13 Pa for at least 30 min.

4.4.6 Weigh the test specimen and control specimen on the balance twice in rotation within 90 min
of removal from the vacuum. If the two readings per specimen are not identical within 0,1 mg, continue
taking readings in rotation until at least two readings per specimen are identical within 0,1 mg. Store the
test specimen and control specimen in a sealed dust-free container between weighings.

2 © ISO 2016 – All rights reserved

 ISO 1 42 42 -2 : 2 01 6(E)

4.4.7 Repeat 4.4.2 to 4.4.6 at intervals until the incremental mass change of the specimen over 2 4 h is

less than 1 0 % of the previous cumulative mass change.

4.4.8 Record the average increase in mass S of the control specimen.

4.5 Procedure for gravimetric measurement

4.5 .1 M ount the test pieces in the testing machine and conduct the wear test in accordance with

I SO 1 42 42 -1 or I SO 1 42 42 -3 as ap prop riate.

4.5 .2 Record the mass of the sp ecimens.

4.5 .3 O n each occasion when the test specimen and control specimen are removed from the wear-

testing machine, rep eat the procedures 4.4.2 to 4. 4. 6, 4.5 .1 and 4.5 .2 .

4.5 .4 C alculate the gravimetric wear as shown in Formula (1 ) :

Wn = Wa n + Sn (1)

where

Wn is the net mas s los s after n c ycle s o f lo ad i ng;

Wa n is the average uncorrec ted mas s los s;

Sn is the average increase in mas s of the control s p ecimen over the s ame p eriod.

4.5 .5 C alculate the average wear rate a G using Formula (2 ) fo r the leas t s quares linear fit relatio ns hip

between Wn and the numb er o f lo ading cycles n :

Wn = a G × n + b (2 )

where Wn is the net los s in mas s after n c ycle s a nd b is a cons tant.

T he zero time p oint shal l not b e used in this calcu lation .

5 Dimensional change method

5 .1 Principle

A co ordinate meas uring machine is used to map the ar ticulating s urface of a total hip pros thes is relative

to a reference p os ition, direc tion and plane prior to the s tar t of the wear tes t and at s uitable inter vals

during the tes t. From these data, the volumetric change b etween meas urements is determ ined. Lo aded

non- ar tic u lati ng control s are i ntende d to a l low the e ffe c ts o f pl as tic flow, ma i n ly o cc u rri ng i n the fi rs t

5 × 10 5 c ycle s , to b e s ep arate d from materi a l lo s s .

5 .2 Apparatus

5 .2 .1 Three-dimensional coordinate measuring machine , with maximum axial-position error of

measurement D , in micrometres, of:

D = 4 + 4 l × 10 – 6 (3 )

where l is the numerical value of the dimens ion, expres sed in metres .

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ISO 1 42 42 -2 : 2 01 6(E)

5 .2 .2 Ultrasonic cleaner .
5 .3 Procedure for dimensional change measurement

5 .3 .1 Select a point of reference, an origin and a plane on the test specimen. Maintain this reference
sys tem thro ugho ut the p ro cedure.

5 .3 .2 Clean the specimens.

5 .3 .3 To ens ure dimens io nal s tab ility, retain the tes t s p ecimen at the meas urement temp erature ± 2 °C

(meas ured at the no rmal p o ints o f the metro lo gy lab o rato ry) fo r at leas t 48 h.

5 .3 .4 At the beginning of a series of tests, check that relocation of the test specimen does not affect the
meas ured vo lume by mo re than 0 , 0 5 % .

T h i s may b e ach ieve d b y the u s e o f fi x turi ng or the re co gnition o f fe atu re s i n s o ftware, for exa mple .

5 .3 .5 Start the measurement machine and produce a full three-dimensional contour mesh of the
articulating surface of the test specimen. Ensure the mesh spacing is no greater than 1 mm in the
ho rizo ntal p lane o r alo ng any arc.

5 .3 .6Calculate the volume Vn o f the acetab ular cavity, where n is the numb er o f wear cycles which

have been applied.

5 .3 .7 Express the wear as the volume change after n lo ading cycles , Δ Vn , as shown in Formula (4):
Δ Vn = Vn – Vo (4)
where Vo is the original volume.
5 .3 .8 I ns ert the tes t s p ecimen and any co ntro l s p ecimen in the tes ting machine and co nduct the tes ts

in accordance with ISO 14242-1 or ISO 14242-3 as appropriate.

On each occasion when the test specimen and the control specimen are removed from the testing
5 .3 .9
machine, repeat procedures 5.3.2 to 5.3.7.
5 .3 .1 0 Calculate the wear rate, aV, using Formula (5) for the least squares linear relationship between
Δ Vn and n as:
ΔVn = a V × n + b (5)
where b i s a con s tant, u s i ng a le as t s quare s fit.

When controls are provided, the slope of the line, representing the rate of creep, should be calculated
including the zero time point. The zero time point shall not be used in the slope calculation for the wear
rate aV.
6 Test report

The test report shall include the following information:

a) a reference to this part of ISO 14242, i.e. ISO 14242-2;
b) the identity o f the te s t s p e ci men s , as s tate d by the p ar ty s ubm itti ng the s p e c i men for te s t;

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 ISO 1 42 42 -2 : 2 01 6(E)

c) the metho d of wear meas urement (i. e. gravimetric or dimens ional change) ;

d) the value Wn for e ach me a s u rement u s i ng the gravi me tric me tho d, or the va lue Vn
Δ for each

meas urement us ing the dimens ional change metho d;

e) the wear rate, a G or a V (gravimetric or dimens ional change metho d) ;

f) a reference to the wear tes t metho d used from I S O 142 42 -1 or I SO 142 42 -3 as appropriate.

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ISO 1 42 42 -2 : 2 01 6(E)

ICS 1 1 .040.40
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