INTERNATIONAL

STANDARD 7206-2
Second edition
1996-06-0 1

Implants for surgery - Partial and total hip

joint prostheses -
Part 2:
Articulating surfaces made of metallic, ceramic
and plastics materials

Implan ts chirurgicaux - Pro theses partielles et totales de I’artkula tion de Ia

hanche -

Partie 2: Surfaces artkulakes cons titu6es de ma tkriaux m6 talliques,

Mamiques et plastiques

Reference number
ISO 7206-2:1996(E)
Licensed to ORTOPRO A.S./SELIM AYAN
ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
 15507206-2: 1996(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide
federation of national Standards bodies (ISO member bodies). The work of
preparing International Standards is normally carried out through ISO
. technical committees. Esch member body interested in a subject for which
a technical committee has been established has the right to be rep-
resented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.

Draft International Standards adopted by the technical committees are

circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.

International Standard ISO 7206-2 was prepared by Technical Committee

lSO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint
replacemen ts.

This second edition cancels and replaces the first edition

(ISO 7206~2:1987), which has been technically revised.

ISO 7206 consists of the following Parts, under the general title Implants
for surgety - Partial and total hip join t pros theses:
- Part 1: Classification and designation of dimensions
- Part 2: Articulating surfaces made of metallic, ceramic and plastics
ma terials
- Part 3: Determination of endurante properties of stemmed femora
componen ts without applica tion of torsion
- Part 4: Determination of endurante properties of stemmed femora
componen ts with applica tion of torsion
- Part 5: Determination of resis tance to s tatic load of and neck
region of s temmed fernoral componen ts
- Part 6: Determination of endurante properties of head and neck
region of stemmed fernoral components

0 ISO 1996
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronie or mechanical, including photocopying and
microfilm, without Permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland

Licensed to ORTOPRO A.S./SELIM AYAN

ii ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
 @ ISO ISO 7206-2: 1996(E)

- Part 7: Endurante Performance of stemmed fernoral components

without application of torsion
- Part 8: Endurante Performance of stemmed fernoral components
with application of torsion
- Part 9: Determination of resis tance to torque of head fixa tion of
stemmed fernoral componen ts

Annex A forms an integral part of this part of ISO 7206.

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
 This page intentionally left blank

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
INTERNATIONAL STANDARD 0 ISO ISO 7206-2: 1996(E)

Implants for surgery - Partial and total hip joint prostheses -

Part 2:
Articulating surfaces made of metallic, ceramic and plastics materials

1 Scope part of ISO 7206 are encouraged to investigate the

possibility of applying the most recent editions of the
This part of ISO 7206 specifies requirements for the Standards indicated below. Members of IEC and ISO
articulating surfaces of those types of total and partial maintain registers of currently valid International
hip joint prostheses that provide a joint replacement Standards.
of ball and socket configuration, as follows:
ISO 468:1982, Surface roughness - Parameters,
a) sphericity and surface finish requirements for their values and general wies for specifying require-
metallic and ceramic fernoral prostheses for par- men ts.
tial hip joint replacement that are in accordance
with classification a) of ISO 7206-1; ISO 7206-1: 1995, Implants for surgery - Partial and
total hip joint prostheses - Part 1: Classification and
b) sphericity and surface finish requirements for designa tion of dimensions.
bipolar heads with plastics inner surfaces which
articulate on fernoral components that are in ac-
cordante with classification a) of ISO 7206-1 and
with metallic or ceramic outer surfaces which ar- 3 Definitions
ticulate on the biological acetabulum;
For the purposes of this part of ISO 7206, the defi-
c) sphericity and surface finish requirements and nitions given in ISO 7206-1 apply.
dimensional tolerantes for plastics acetabular
components that are in accordance with classifi-
cation b) of ISO 7206-1;
4 Requirements
d) sphericity and surface finish requirements and
dimensional tolerantes for metallic or ceramic
fernoral components of total hip joint prostheses 4.1 Fernoral components of total hip joint
that are in accordance with classification c) of prostheses
ISO 7206-1, designed to articulate on plastics
acetabular components.
NOTE 1 This subclause refers to spherical articulating
surfaces of fernoral components of total joint hip pros-
theses in accordance with classification c) of ISO 7206-1.
2 Normative references
4.1.1 Sphericity
The following Standards contain provisions which,
through reference in this text, constitute provisions of When measured in accordance with the method given
this part of ISO 7206. At the time of publication, the in A.l, the departure from sphericity of the spherical
editions indicated were valid. All Standards are subject articulating surface of a fernoral component shall have
to revision, and Parties to agreements based on this a radial Separation value not greater than 10 um.
Licensed to ORTOPRO A.S./SELIM AYAN
ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
ISO 7206-2: 1996(E) @ ISO

4.1.2 Sutface finish to + 0,3 mm at a temperature of 20 “C + 2 “C (i.e. it

shall be oversized within the given tolerante).
When measured in accordance with the principles
given in ISO 468, the spherical articulating surfaces of
4.3 Fernoral prostheses for partial joint
metallic and ceramic components shall have R, values
not greater than 0,05 um and 0,02 um respectively, replacements
using a cutoff value of 0,08 mm.
NOTE 3 This subclause refers to spherical articulating
The following details should be reported: surfaces of fernoral prostheses for partial joint replace-
ments in accordance with classification a) of ISO 7206-1.
a) stylus tip radius;
4.3.1 Sphericity
b) Position of measurement on specimen.
When measured in accordance with the method given
When examined by normal or corrected Vision, the in A.1, the departure from sphericity of the spherical
articulating surface shall be free from embedded articulating surface shall have a radial Separation value
particles and from scratches and Score marks other no greater than 100 um.
than those arising from the finishing process.
4.3.2 Surface finish
4.1.3 Dimensional tolerantes
When measured in accordance with the principles
The spherical head shall have a diameter equal to the given in ISO 468, the spherical articulating surface of
nominal diameter within a tolerante of - 0,2 mm to the implant shall have an R, value not greater than
0 mm. 0,5 um, using a cutoff value of 0,08 mm.

The following details should be reported:

4.2 Plastics acetabular components
a) stylus tip radius;
NOTE 2 This subclause refers to plastics acetabular com-
ponents for total hip joint replacements in accordance with b) Position of measurement on specimen.
classification b) of ISO 7206-1.
When examined by normal or corrected Vision, the
4.2.1 Sp hericity articulating surface shall be free from embedded
particles and from scratches a Id Score ma rks other
When measured in accordance with the method giver than those arising from the finis iing process.
in A.2, the departure from sphericity shall have a radial
Separation value no greater than 100 um. 4.3.3 Dimensional tolerantes

4.2.2 Surface finish The tolerante for the spherical h ead shall be +0,5 mm
on the nominal diameter-.
When measured in accordance with the principles
given in ISO 468, the spherical articulating surface of
the implant shall have an R, value not greater than 4.4 Bipolar heads
2 um, using a cutoff value of 0,08 mm.
NOTE 4 This subclause refers to bipolar heads for fernoral
The following details should be reported: prostheses consisting of a concave (inner) spherical surface
in a plastics component intended to articulate with a
a) stylus tip radius; fernoral component of a partial or total hip joint. The bipolar
head has also a convex (outer) spherical surface which is
b) Position of measurement on specimen. intended to articulate with the biological acetabulum.

When examined by normal or corrected Vision, the 4.4.1 Inner articulating surface
articulating surface shall be free from embedded
particles and from scratches and Score marks other The inner articulating surface of the plastics part of a
than those arising from the finishing process. bipolar head shall comply with 4.2.

4.2.3 Dimensional tolerantes 4.4.2 Outer articulating surface

The spherical socket shall have a diameter equal to The outer articulating surface of a bipolar head shall
the nominal diameter within a tolerante of + 0,l mm comply with 4.3.

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
2 Single user licence only, copying and networking prohibited
 ISO 7206-2: 1996(E)

Annex A
(normative)
Determination of radial Separation value

A.l Fernoral ball A.2 Acetabular cup

Using a three-dimensional measuring machine with a Using a three-dimensional measuring machine with a
measuring stylus which will allow contact with any measuring stylus which will allow contact with any
Point on the articulating surface to be tested, measure Point on the articulating surface to be tested, measure
the coordinates of 25 Points P’ on the articulating the coordinates of 25 Points P’ of the articulating
surface, 8 spaced equally round the circumference in surface, 8 spaced equally round the circumference in
each of the planes AA, BB and CC, and 1 Point at the each of the planes AA, BB and CC, and 1 Point at the
pole (P) (see figure A.l). pole (P) (see figure A.2).

The pole is the intersection of the axis of the neck Plane AA shall be a diametral plane or, if the articulat-
with the articulating surface. Planes AA, BB and CC ing surface extends to less than half of a circumfer-
shall be perpendicular to the axis of the neck. If the ence, it shall intersect the articulating surface within
articulating surface extends to half of the circumfer- 1 mm of its border. The pole shall lie on the perpen-
ence or to more than half, AA shall be a diametral dicular drawn from the centre of the plane AA.
plane, otherwise it shall intersect the articulating
surface within 1 mm of its border. Angles a, b and c define the positions of the planes
AA, BB and CC relative to the axis through the pole
Angles a, b and c define the positions of the planes and shall meet the following requirements:
AA, BB and CC relative to the neck axis and shall
meet the following requirements: c = a/3
c = aJ3
b = 2a/3
b = 2af3
NOTE 6 If AA is a diametral plane, a = 90°, b = 60” and
NOTE 5 If AA is a diametral plane, a = 90°, b = 60” and c = 30”.
c = 30”.
Determine, using the least squares method, the
Determine, using the least squares method, the average diameter D and the coordinates of the centre
average diameter D and the coordinates of the centre 0 of the sphere of average diameter.
0 of the sphere of average diameter.
Calculate, for each of the 25 measurement Points P’,
Calculate, for each of the 25 measurement Points P’, the radial Separation value R,, using the equation:
the radial Separation value R,, using the equation:

Rs = distance OP’ - 0,5D R, = distance OP’ - 0,5D

The radial Separation value referred to in 4.1 .l shall be The radial Separation value referred to in 4.2.1 shall be
the greatest of these calculated values. the greatest of these calculated values.

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
ISO 7206-2: 1996(E) @ ISO

Dimensions in millimetres

Articulating surfac

articulating surface ,

Figure A.1 - Location of points to be measured on the spherical head

Dimensions in millimetres

End of
articulating surface

Figure A.2 - Location of Points to be measured on the acetabulum

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
4 Single user licence only, copying and networking prohibited
 This page intentionally left blank

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
 This page intentionally left blank

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
 This page intentionally left blank

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited
ISO 7206-2: 1996(E) @ ISO

ICS 11.040.40
Descriptors: medical equipment, surgical implants, orthopaedic implants, hips, joints (articulation), prosthetic devices, specifications.

Price based on 4 pages

Licensed to ORTOPRO A.S./SELIM AYAN

ISO Store order #: 559551/Downloaded: 2003-09-16
Single user licence only, copying and networking prohibited