BRITISH STANDARD BS 7251-13:

1995
ISO 7206-9:
1994

Orthopaedic joint
prostheses —
Part 13: Method for determination of
resistance to torque of head fixation of
stemmed femoral components
BS 7251-13:1995

Committees responsible for this

British Standard

The preparation of this British Standard was entrusted to Technical

Committee CH/25, Orthopaedic joint prostheses, upon which the following
bodies were represented:

Association of British Healthcare Industries

British Institute of Surgical Technologists
British Orthopaedic Association
British Steel Industry
British Surgical Trades Association
Department of Health
Department of Trade and Industry (National Engineering Laboratory)
Royal College of Surgeons of England
Scottish Office

This British Standard, having

been prepared under the
direction of the Health and
Environment Sector Board,
was published under the
authority of the Standards
Board and comes
into effect on
15 October 1995 Amendments issued since publication

© BSI 09-1999 Amd. No. Date Comments

The following BSI references

relate to the work on this
standard:
Committee reference CH/25
Draft for comment 93/500963 DC

ISBN 0 580 24837 2

 BS 7251-13:1995

Contents

Page
Committees responsible Inside front cover
National foreword ii
Introduction 1
1 Scope 1
2 Normative references 1
3 Definitions 1
4 Principle 1
5 Reagent 1
6 Apparatus 1
7 Procedure 2
8 Test report 3
9 Disposal of test specimens 3
Figure 1 — Example of equipment for determination
of resistance to torque of head/neck assembly 2
List of references Inside back cover

© BSI 09-1999 i
BS 7251-13:1995

National foreword

This Part of BS 7251 has been prepared by Technical Committee CH/25. It is

identical with ISO 7206-9:1994 Implants for surgery — Partial and total hip joint
prostheses — Part 9: Determination of resistance to torque of head fixation of
stemmed femoral components, published by the International Organization for
Standardization (ISO).
Textual error. When adopting the text of the International Standard, the
textual error given below was discovered. It has been marked in the text and has
been reported to the International Organization for Standardization (ISO) in a
proposal to amend the text of the International Standard.
In clause 1, paragraph 1, line 7 “head and arm” should be “head and neck”.
Cross-reference
International Standard Corresponding British Standard
ISO 3696:1987 BS 3978:1987 Specification for water for laboratory
use
The Technical Committee has reviewed the provisions of ISO 7206-1 to which
normative reference is made in the text and has decided that they are acceptable
for use in conjunction with this standard. A related British Standard to
ISO 7206-1 is BS 7251-3:1990 Orthopaedic joint prostheses —
Part 3: Specification for classification, designation of dimensions and
requirements for hip joint prostheses.
A British Standard does not purport to include all the necessary provisions of a
contract. Users of British Standards are responsible for their correct application.

Compliance with a British Standard does not of itself confer immunity

from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, pages i and ii,
pages 1 to 4, an inside back cover and a back cover.
This standard has been updated (see copyright date) and may have had
amendments incorporated. This will be indicated in the amendment table on the
inside front cover.

ii © BSI 09-1999

Introduction
Some designs of stemmed femoral components of
total hip joint prostheses comprise a stem/neck
component and a bearing head component, which is
commonly in the form of a partial sphere
incorporating a female fixation feature for
attachment to the neck of the stem. Such heads are
generally produced in metal or in ceramic material.
It is important that after assembly, whether by the
manufacturer or by the surgeon in the operating
theatre, the head subsequently remains immobile
on the neck, because movement of the ceramic
component on the metal component will cause the
metal component to wear, whilst metal-on-metal
movement may lead to severe fretting corrosion. It
is essential, therefore, that the strength of the
fixation between the head and the neck is sufficient
to withstand the torque likely to be transmitted
through the prosthesis in use. It should be noted
that the test conditions described in this part of
ISO 7206 do not exactly reproduce all the factors in
the clinical situation.
1 Scope
This part of ISO 7206 describes a method of
determining the torque required, under specified
laboratory conditions, to loosen the fixation of the
head of hip joint prostheses in which the head is not
intended to rotate relative to the neck. It applies to
the femoral component of total or partial hip joint
replacements in which the head and arm1) are
secured together by a locking conical taper or any
other means and in which the head and neck are
separate components, and which are made of
metallic and non-metallic materials.
This part of ISO 7206 does not cover methods of
examining the test specimens; these should be
agreed between the test laboratory and the party
submitting the specimen for test.
2 Normative references
The following standards contain provisions which,
through reference in this text, constitute provisions
of this part of ISO 7206. At the time of publication,
the editions indicated were valid. All standards are
subject to revision, and parties to agreements based
on this part of ISO 7206 are encouraged to
investigate the possibility of applying the most
recent editions of the standards indicated below.
Members of IEC and ISO maintain registers of
currently valid International Standards.
ISO 3696:1987, Water for analytical laboratory
use — Specification and test methods.
1) See national foreword for details of textual error
2) To be published. (Revision of ISO 7206-1:1985)
© BSI 09-1999
BS 7251-13:1995
ISO 7206-1:—, Implants for surgery — Partial and
total hip joint prostheses — Part 1: Classification
and designation of dimensions2).
3 Definitions
For the purposes of this part of ISO 7206, the
definitions given in ISO 7206-1 apply.
4 Principle
Mounting of the head on a firmly fixed neck unit.
Immersion of the assembly in liquid at a controlled
temperature. Application of an axial load to the
assembly. Application of a torque to the head and
the measurement of the torque required to initiate
rotation of the head on the neck.
5 Reagent
Fluid test medium, comprising either:
a) distilled or deionized water of Grade 3 in
accordance with ISO 3696; or
b) liquid of a composition stated by the party
submitting the specimen for test.
6 Apparatus
See Figure 1 for an example of test apparatus.
6.1 Specimen holder, of a corrosion-resistant
material, and having a construction and dimensions
to suit the testing machine and test specimen.
6.2 Testing machine, capable of applying an axial
load through the axis of the head/neck assembly,
with accuracy of 1 % of full scale reading, and of
applying a torque to the head in a plane at right
angles to the axial load, with an accuracy of 1 % of
full scale reading.
6.3 Means of transmitting the axial load, e.g. an
acetabular cup of ultra-high-molecular-weight
polyethylene.
6.4 Means of maintaining the temperature of the
fluid test medium at 37 °C ± 1 °C.
6.5 Means of continuously aerating the fluid test
medium, e.g. a small air pump of the type used for
aquaria.
6.6 Means of measuring the torque applied to the
head of the assembly, with an accuracy of 1 %.
1
BS 7251-13:1995
Figure 1 — Example of equipment for determination of resistance to torque of
head/neck assembly
6.7 Neck unit, comprising a neck/stem of the type to
which the head is to be fitted in service, or a dummy
neck having the same dimensions and being made of
the same material, by the same manufacturing
process and to the same specification.
NOTE 1 The use of a dummy neck is convenient and economical
compared with fully finished femoral components: however in
cases of dispute the test should be performed using the complete
stemmed femoral component.
7 Procedure
7.1 If the head is not in place on the stem, mount the
head to be tested on the neck unit (6.7) in the
manner recommended by the manufacturer, and
mount the assembly in the specimen holder (6.1). If
the head is in place on the stem, mount the
assembly in the specimen holder.
7.2 Mount the specimen holder and assembly in the
testing machine (6.2).
2 © BSI 09-1999
7.3 Apply and maintain a load of 1 000 N axially to
the head through the loading device (6.3).
7.4 Circulate heated fluid test medium through the
specimen holder until the temperature of the holder
and contents stabilizes at 37 °C ± 1 °C. Maintain
this temperature and maintain aeration of the fluid
test medium (6.4 and 6.5). Allow all electronic
amplifiers, recorders, etc. that form part of the test
equipment to reach a stable operating temperature.
7.5 Apply (6.2) an incrementally increasing torque
to the head until the head begins to rotate on the
neck, continuously recording the torque applied.
Note the maximum torque applied before rotation
commences. Record or calculate from the recording
the rate of application of torque.
If fixation is achieved by the use of a screw thread
the torque should be applied in the loosening
direction.
 BS 7251-13:1995

NOTE 2 Depending on the means used for gripping the head, it 9 Disposal of test specimens
may be necessary to grind small flats on the surface of the head,
especially in the case of hard materials such as ceramics. No part of the prosthesis shall be used for clinical
7.6 Remove the head/neck assembly from the purposes after testing.
testing machine and specimen holder. This test normally results in the transfer of material
7.7 Examine the test specimens, using the methods from one component to the other and changes the
requested by the party that submitted the specimen nature of both mating surfaces. Care should be
for testing. exercised in the use of the specimen for further
mechanical tests because the loading regime may
8 Test report have altered the mechanical properties. In
particular, it is recommended that neither the
The test report shall include the following
neck/stem components nor the head are used for
information:
further testing by the method given in this part of
a) a reference to this part of ISO 7206; ISO 7206.
b) the identity of the test specimen, as stated by
the party submitting the specimen for test;
c) the maximum torque applied before the head
commenced to rotate on the neck;
d) the torque application rate;
e) the results of the examination requested by the
party submitting the specimen for test.

© BSI 09-1999 3
4 blank
 BS 7251-13:1995

List of references

See national foreword.

© BSI 09-1999
BS 7251-13:
1995
ISO 7206-9: BSI — British Standards Institution
1994
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