ISO 5834-2:2025

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

This document specifies the requirements and corresponding test methods for moulded forms (e.g. sheets, rods and near net shape bars) made from ultra-high-molecular-weight polyethylene (UHMWPE) powder for use in the manufacture of surgical implants. This document is not applicable to moulded forms that were intentionally irradiated, that were made from UHMWPE blended with additives or UHMWPE blended with different forms of polyethylene, and the packaged and sterilized finished implant.

Implants chirurgicaux — Polyéthylène à très haute masse moléculaire — Partie 2: Produits sous forme moulée

General Information

• Status: Published
• Publication Date: 03-Jul-2025
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 1 - Materials
• Drafting Committee: ISO/TC 150/SC 1 - Materials
• Current Stage: 6060 - International Standard published
• Start Date: 04-Jul-2025
• Due Date: 05-Dec-2025
• Completion Date: 04-Jul-2025

Relations

• Revises: ISO 5834-2:2019 - Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms
• Effective Date: 23-Dec-2023

Standards Content (Sample)

International
Standard
ISO 5834-2
Sixth edition
Implants for surgery — Ultra-high-
2025-07
molecular-weight polyethylene —
Part 2:
Moulded forms
Implants chirurgicaux — Polyéthylène à très haute masse
moléculaire —
Partie 2: Produits sous forme moulée
Reference number
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification, designation and coding . 2
5 Material. 2
6 Manufacturing requirements . 2
7 Requirements . 2
7.1 Physical properties .2
7.2 Particulate matter .2
8 Test methods . 3
8.1 Test conditions .3
8.2 Density .3
8.3 Tensile testing .3
8.3.1 General .3
8.3.2 Tensile stress at yield .3
8.3.3 Tensile stress at break .3
8.3.4 Elongation at break .3
8.4 Notched impact strength . .3
8.5 Sample area for particulate matter . .3
9 Identification marking . 3
10 Test certificate . 4
11 Labelling . 4

iii
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
This sixth edition cancels and replaces the fifth edition (ISO 5834-2:2019), which has been technically
revised.
The main changes are as follows:
— the normative references have been updated;
— updates have been made to harmonize this document with ASTM F648-21;
— req
...

International
Standard
ISO 5834-2
Sixth edition
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
PROOF/ÉPREUVE
Reference number
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
PROOF/ÉPREUVE
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification, designation and coding . 2
5 Material. 2
6 Manufacturing requirements . 2
7 Requirements . 2
7.1 Physical properties .2
7.2 Particulate matter .2
8 Test methods . 3
8.1 Test conditions .3
8.2 Density .3
8.3 Tensile testing .3
8.3.1 General .3
8.3.2 Tensile stress at yield .3
8.3.3 Tensile stress at break .3
8.3.4 Elongation at break .3
8.4 Notched impact strength . .3
8.5 Sample area for particulate matter . .3
9 Identification marking . 3
10 Test certificate . 4
11 Labelling . 4
PROOF/ÉPREUVE
iii
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
This sixth edition cancels and replaces the fifth edition (ISO 5834-2:2019), which has been technically
revised.
The main changes are as follows:
— the normative references have been updated;
— updates to harmonize with ASTM F648-21;
— requirements have been added to Clause 11.
A l
...

ISO/PRF 5834-2:2025(en)
ISO TC150/SC1/WG5/TC 150/SC 1
Secretariat: DIN
Date: 2025-05-09
Implants for surgery — Ultra-high-molecular-weight polyethylene
— —
Part 2:
Moulded forms
Sixth edition
Date: 2025-01-08
Implants chirurgicaux — Polyéthylène à très haute masse moléculaire —
Partie 2: Produits sous forme moulée
PROOF
ISO/PRF 5834-2:2025(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/PRF 5834-2:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification, designation and coding . 1
5 Material . 2
6 Manufacturing requirements . 2
7 Requirements . 2
7.1 Physical properties . 2
7.2 Particulate matter . 2
8 Test methods . 3
8.1 Test conditions . 3
8.2 Density . 3
8.3 Tensile testing . 3
8.4 Notched impact strength . 3
8.5 Sample area for particulate matter . 3
9 Identification marking . 3
10 Test certificate . 4
11 Labelling . 4

iii
ISO/PRF 5834-2:2025(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
This sixth edition cancels and replaces the fifth edition (ISO 5834-2:2019), which has been technically revised.
The main changes are as follows:
— — updates to the normative references have been updated;
— — updates to harmonize with ASTM F648-21;
— Addition of requirements have been added to 11in clause 11 Labelling.
A list of all parts in the ISO 5834 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/PRF 5834-2:2025(en)
Introduction
While no known surgical implant material has ever been shown to cause absolutely no adverse reactions in
the human body, long-term clinical experience with the material referred to in this document has shown that
an acceptable level of biological response can be expected when the material is used in appropriate
applications. However, this document covers the raw material and not finished medical devices, where the
design and fabrication of the device can impact biological response.
v
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