ISO 5834-1:2025

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form

This document specifies the requirements and corresponding test methods for ultra-high-molecular-weight polyethylene (UHMWPE) powder moulding materials for use in the manufacturing of moulded forms that are subsequently used in the manufacturing of surgical implants. This document is not applicable to UHMWPE moulding materials that were blended with any additives or different forms of polyethylene.

Implants chirurgicaux — Polyéthylène à très haute masse moléculaire — Partie 1: Produits sous forme de poudre

Le présent document spécifie les exigences et les méthodes d'essai correspondantes pour les produits à mouler sous forme de poudre de polyéthylène à très haute masse moléculaire (PE-UHMW), utilisés dans la fabrication d'implants chirurgicaux. Il ne s'applique pas aux produits finis.

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/WG 5 - Plastics
• Current Stage: 6060 - International Standard published
• Start Date: 04-Jul-2025
• Due Date: 05-Dec-2025
• Completion Date: 04-Jul-2025

Relations

• Revises: ISO 5834-1:2019 - Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
• Effective Date: 09-Dec-2023

Standards Content (Sample)

International
Standard
ISO 5834-1
Fifth edition
Implants for surgery — Ultra-high-
2025-07
molecular-weight polyethylene —
Part 1:
Powder form
Implants chirurgicaux — Polyéthylène à très haute masse
moléculaire —
Partie 1: Produits sous forme de poudre
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 Manufacturing requirements . 2
6 Flow properties . 2
7 Limits of contamination . 2
7.1 Ash and trace elements .2
7.2 Particulate matter .2
8 Test methods . 3
8.1 Elongational stress .3
8.2 Viscosity number .3
8.3 Ash content .3
8.4 Trace elements .3
8.5 Particulate matter procedure .3
9 Test certificate . 3
10 Labelling . 3
Bibliography . 5

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 fifth edition cancels and replaces the fourth edition (ISO 5834-1:2019), which has been technically
revised.
The ma
...

International
Standard
ISO 5834-1
Fifth edition
Implants for surgery — Ultra-high-
molecular-weight polyethylene —
Part 1:
Powder form
Implants chirurgicaux — Polyéthylène à très haute masse
moléculaire —
Partie 1: Produits sous forme de poudre
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 Manufacturing requirements . 2
6 Flow properties . 2
7 Limits of contamination . 2
7.1 Ash and trace elements .2
7.2 Particulate matter .2
8 Test methods . 3
8.1 Elongational stress .3
8.2 Viscosity number .3
8.3 Ash content .3
8.4 Trace elements .3
8.5 Particulate matter procedure .3
9 Test certificate . 3
10 Labelling . 3
Bibliography . 5
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 fifth edition cancels and replaces the fourth edition (ISO 5834-1:2019), which has been technically
revised.
The main changes are as follows:
— the normativ
...

ISO/PRF 5834-1:2025(en)
ISO/TC 150/SC 1
Secretariat: DIN
Date: 2025-05-09
Implants for surgery — Ultra-high-molecular-weight polyethylene
— —
Part 1:
Powder form
Fifth edition
Date: 2025-01-08
Implants chirurgicaux — Polyéthylène à très haute masse moléculaire —
Partie 1: Produits sous forme de poudre
PROOF
ISO/PRF 5834-1:2025(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 5834-1:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification, designation and coding . 2
5 Manufacturing requirements . 2
6 Flow properties . 2
7 Limits of contamination . 2
7.1 Ash and trace elements . 2
7.2 Particulate matter . 2
8 Test methods . 3
8.1 Elongational stress . 3
8.2 Viscosity number . 3
8.3 Ash content . 3
8.4 Trace elements . 3
8.5 Particulate matter procedure . 3
9 Test certificate . 3
10 Labelling . 4
Bibliography . 5

iii
ISO/PRF 5834-1:2025(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/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 fifth edition cancels and replaces the fourth edition (ISO 5834-1:2019), which has been technically
revised.
The main changes are as follows:
— — updates to the normative references have been updated;
— — updates to the properties in Table 1Table 1 have been updated to harmonize with ASTM F648-21.
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 5834-1:2025(en)
Introduction
While no known surgical implant material has ever been shown to cause a
...