BRITISH STANDARD BS 7251-12:

1995
ISO 7206-8:
1995

Orthopaedic joint
prostheses —
Part 12: Specification for endurance of
stemmed femoral components with
application of torsion
BS 7251-12:1995

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 Amendments issued since publication
15 October 1995

© BSI 07-1999 Amd. No. Date Comments

The following BSI references

relate to the work on this
standard:
Committee reference CH/25
Draft for comment 93/505052 DC

ISBN 0 580 24838 0

 BS 7251-12:1995

Contents

Page
Committees responsible Inside front cover
National foreword ii
Introduction 1
1 Scope 1
2 Normative reference 1
3 Test conditions 1
4 Endurance performance 1
List of references Inside back cover

© BSI 07-1999 i
BS 7251-12:1995

National foreword

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

identical with ISO 7206-8:1995 Implants for surgery — Partial and total hip joint
prostheses — Part 8: Endurance performance of stemmed femoral components
with application of torsion, published by the International Organization for
Standardization (ISO).
Cross-reference
International standard Corresponding British Standard
ISO 7206-4:1989 BS 7251 Orthopaedic joint prostheses
Part 5:1990 Method for determination of endurance
properties of stemmed femoral components of hip joint
prostheses with application of torsion
(Technically equivalent)
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 and 2, 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 07-1999

Introduction
Fatigue properties are important attributes of in
vivo performance of orthopaedic implants.
Part 4 of this International Standard provides a
means of evaluating designs of femoral components
of partial or total hip joint replacements but more
data on different stem designs for the smallest stem
sizes needs to be obtained to establish minimum
loading values using this test method for sizes
smaller than those intended for the average size
patient (in Europe). More data is also required to
establish correlation of the results from this test
method in relation to specific designs and materials,
and to reflect developing clinical experience.
1 Scope
This part of ISO 7206 specifies the endurance
performance of stemmed femoral components of
total hip joint prostheses and stemmed femoral
components used alone in partial hip joint
replacement as determined under specified
laboratory conditions by a method that includes
the application of torsion.
This part of ISO 7206 does not apply to the
following:
a) prostheses for special clinical cases;
b) prostheses for which the centreline of the stem
is three-dimensionally curved and does not lie in
any plane in which the axis of the neck lies.
© BSI 07-1999
ISO 7206-8:1995(E)
2 Normative reference
The following standard contains provisions which,
through reference in this text, constitute provisions
of this part of ISO 7206. At the time of publication,
the edition indicated was 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 edition of the standard indicated below.
Members of IEC and ISO maintain registers of
currently valid International Standards.
ISO 7206-4:1989, Implants for surgery —
Partial and total hip joint prostheses —
Part 4: Determination of endurance properties of
stemmed femoral components with application of
torsion.
3 Test conditions
The femoral component shall be tested in its
ready-for-use condition.
4 Endurance performance
When tested as described in ISO 7206-4, the femoral
component shall not fracture during 5 × 106 cycles
of application of a cyclic load of 2 kN with a
minimum load of 300 N and a maximum load
of 2,3 kN. Neither shall the tests have been
terminated before completion of the loading regime
(see ISO 7206-4:1989, subclause 7.8) for reasons
other than loosening of the specimen in the
embedding medium.
1
2 blank
 BS 7251-12:1995

List of references

See national foreword.

© BSI 07-1999
BS 7251-12:
1995
ISO 7206-8: BSI — British Standards Institution
1995
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