National foreword

This British Standard is the UK implementation of ISO 5833:2026. It supersedes BS ISO 5833:2002, which is withdrawn.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 October 2026.

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 third edition cancels and replaces the second edition (ISO 5833:2002), which has been technically revised.

The main changes are as follows:

the scope has been amended to specify that the requirements in this document do not apply to acrylic resin cements for other applications;
ASTM F451‑21 has been added as a normative reference;
terms and definitions of ASTM F451 have been cited in Clause 3;
subclause 5.4 on initiator agent concentration has been added, which includes a requirement for the measuring the concentration of the initiator agent;
Clauses 6 and 7 have been revised and a new Clause 8 has been added which include the requirements for liquid-powder mixture intended for syringe usage, use in dough state, and dual usage (both syringe and dough state usage), respectively.
a requirement to perform an extrusion viscosity test has been added to 6.2;
a clarification for when to perform an intrusion test has been added to 7.2;
a clarification for when to perform both an intrusion and extrusion test has been added to 8.2;
subclause 9.2 on monitoring leachable monomer from set and polymerized cement has been added to provide a requirement to measure leaching monomer from set and polymerized cement over time;
a new Clause 12 has been added on biocompatibility;
the reporting sections in all Annexes have been revised;
bibliographical references have been added.

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.

1 Scope

This document specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly (methacrylic acid esters). This document applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.

All requirements in this document apply to, and all test methods are intended to be performed on, a sterile product.

The requirements in this document are not intended to apply to acrylic resin cements for other applications, such as stabilization of spinal fractures, fixation of bone screws, bone anchors or augments, etc., although the test methods described can be applicable.

This document does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.

2 Normative references

3 Terms and definitions

4 Liquid component

4.1 Appearance

4.2 Stability

4.3 Accuracy of contents

5 Powder component

5.1 General

5.2 Appearance

5.3 Accuracy of contents

5.4 Initiator agent concentration

6 Liquid-powder mixture intended for syringe usage

6.1 Setting properties, test methods and requirements

6.2 Extrusion

7 Liquid-powder mixture intended for use in dough state

7.1 Setting properties, test methods and requirements

7.2 Intrusion

8 Liquid-powder mixture intended for dual usage (both syringe and dough state usage)

8.1 Setting properties, test methods and requirements

8.2 Intrusion and extrusion

9 Set and polymerized cement

9.1 General

9.2 Monitoring leachable monomer from set and polymerized cement

10 Packaging

10.1

10.2

10.3

11 Labelling

11.1 Unit package

11.2 Accompanying documentation

12 Biocompatibility

12.1 General

Bibliography