ISO 5834-3:2025

International
Standard
ISO 5834-3
Third edition
Implants for surgery — Ultra-high-
2025-07
molecular-weight polyethylene —
Part 3:
Accelerated ageing methods after
gamma irradiation in air
Reference number
© ISO 2025
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Published in Switzerland
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Material. 2
5 Apparatus and test specimens . 2
6 Validation of apparatus . 2
7 Conditioning . 2
8 Significance and use . 2
9 Accelerated ageing procedure . 3
10 Reporting . 3
10.1 General .3
10.2 Test specimen preparation .3
10.3 Chronology .3
10.4 Test specimen storage conditions .3
10.5 Ageing method .3
Bibliography . 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
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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
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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
This third edition cancels and replaces the second edition (ISO 5834-3:2019), 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 F2003-02.
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
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 unfinished medical devices, where the
design and fabrication of the device can impact biological response.

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