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
 BS 7251-13:1995

Introduction ISO 7206-1:—, Implants for surgery — Partial and

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

2 © BSI 09-1999
 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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