ISO 5834-2:1998

INTERNATIONAL ISO
STANDARD 5834-2
Second edition
1998-08-01
Implants for surgery — Ultra-high molecular
weight polyethylene —
Part 2:
Moulded forms
Implants chirurgicaux — Polyéthylène à très haute masse moléculaire —
Partie 2: Produits sous forme moulée
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Reference number
Contents Page
1  Scope . 1
2  Normative references . 1
3  Definitions . 2
4  Classification. 2
5  Material . 2
6  Manufacturing requirements . 2
7  Requirements. 2
8  Test methods. 2
9  Identification marking . 4
10 Test certificate. 4
11 Labelling . 4
©  ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
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ISO ISO 5834-2:1998(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. Each member body interested in a subject for which a technical committee has been established has
the right to be represented 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 5834-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery,
Subcommittee SC 1, Materials.
This second edition cancels and replaces the first edition (ISO 5834-2:1985), which has been technically revised.
ISO 5834 consists of the following parts, under the general title Implants for surgery — Ultra-high molecular weight
polyethylene:
 Part 1: Powder form
 Part 2: Moulded forms
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INTERNATIONAL STANDARD  ISO ISO 5834-2:1998(E)
Implants for surgery — Ultra-high molecular weight
polyethylene —
Part 2:
Moulded forms
1  Scope
This part of ISO 5834 specifies the requirements and corresponding test methods for moulded forms made from
ultra-high molecular weight polyethylene (PE-UHMW) for use in the manufacture of surgical implants.
It does not apply to direct-moulded or finished products.
2  Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part of
ISO 5834. At the time of publication, the editions indicated were valid. All the standards are subject to revision, and
the parties to agreements based on this part of ISO 5834 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 Standard.
ISO 527:1976, Plastics — Determination of tensile properties.
ISO 1183:1987, Plastics — Methods for determining the density and relative density of non-cellular plastics.
ISO 3451-1:1997, Plastics — Determination of ash — Part 1: General methods.
ISO 5834-1:1998, Implants for surgery — Ultra-high molecular weight polyethylene — Part 1: Powder form.
ISO 11542-1:1994, Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion
materials — Part 1: Designation systems and basis for specifications.
1)
ISO 11542-2:— , Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion
materials — Part 2: Preparation of test specimens and determination of properties.
ASTM F 648, Standard specification for ultra-high molecular weight polyethylene powder and fabricated form for
surgical implants.
1) To be published.
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3  Definitions
For the purposes of this part of ISO 5834, the definitions given in ISO 11542-1 and ISO 11542-2 apply.
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