National foreword

This British Standard is the UK implementation of ISO 5834‑4:2025. It supersedes BS ISO 5834‑4:2019, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2025.

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.

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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 5834‑4:2019), 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 F2102‑17.

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.

Introduction

This document describes a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical implants. The material is analysed by infrared spectroscopy. The intensity of the carbonyl absorptions (>C=O) centred near 1 720 cm⁻¹ is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (R₁OR₂, R₁OOR₂, ROH, etc.) are not detected by this method.

Although this method provides the investigator with a means to compare the relative extent of carbonyl oxidation present in various UHMWPE specimens, it is recognized that other forms of chemically bound oxygen can be important contributors to characteristics of these materials.

The applicability of the infrared method has been demonstrated by many literature reports. This particular method, using the intensity (area) of the C-H absorption centred near 1 370 cm⁻¹ to normalize for the specimen’s thickness, has been validated by an interlaboratory study (ILS).

1 Scope

This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms or forms fabricated for use in the manufacture of surgical implants.

2 Normative references

3 Terms and definitions

4 Materials and apparatus

4.1 Materials

4.2 Apparatus

5 Significance and use

6 Procedure

6.1 Preparation of test specimens

6.2 Configuration of test specimen in the spectrometer

6.3 Preparation of the infrared spectrometer

7 Calculations

7.1 General

7.2 Oxidation peak area

7.3 Normalization peak area

7.4 Oxidation index

7.5 Depth locator

7.6 Specimen's surface oxidation index

7.7 Specimen's bulk oxidation index

7.8 Specimen's oxidation index profile

8 Reports

8.1 General

8.2 Information concerning the material

8.3 Specimen information

8.4 IR spectrometer parameters

8.5 Calculation methods

8.6 Specimen's calculated surface oxidation index

8.7 Specimen's calculated bulk oxidation index

8.8 Specimen's calculated oxidation index profile

Bibliography

BS ISO 5834-4:2025

Implants for surgery. Ultra-high-molecular-weight polyethylene - Oxidation index measurement method

Current

Published:

31 Jul 2025