ISO 5833

• Abstract:

  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). It 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. 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. All requirements apply to, and all tests are intended to be performed on, the sterile product.

• Status: Not Published
• 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: 6000 - International Standard under publication
• Start Date: 04-Sep-2026
• Completion Date: 26-Sep-2026

• Revises: ISO 5833:2002 - Implants for surgery — Acrylic resin cements
• Effective Date: 09-Dec-2023

Overview

ISO 5833: Implants for surgery - Acrylic resin cements is an international standard developed by ISO for specifying requirements and test methods for acrylic resin cements used in surgical implants. This standard covers the physical and mechanical properties, as well as packaging and labeling, for both radio-opaque and non-radio-opaque polymerizing cements based on poly(methacrylic acid esters). These cements are commonly used for the fixation of internal orthopaedic prostheses and are supplied as pre-measured, sterile powder and liquid components suitable for mixing at the point of care.

Adherence to ISO 5833 helps manufacturers and healthcare professionals ensure the quality, safety, and efficacy of acrylic bone cements used during orthopaedic and surgical implant procedures.

Key Topics

• Product Types: The standard applies to two primary forms of acrylic resin cements-those designed for syringe application and those intended for dough state usage.
• Sterility Requirements: All requirements and test methods are stipulated for the sterile final product, focusing on minimizing contamination risks.
• Physical and Mechanical Properties:
  • Setting properties, including doughing time and setting time
  • Temperature characteristics during polymerization
  • Compressive strength, bending modulus, and bending strength of the set material
• Intrinsic Composition:
  • Evaluation and measurement of powder and liquid components, initiator agent concentration, and radio-opacity
  • Monitoring of leachable monomer post-curing
• Packaging and Labelling:
  • Requirements for double-layer sterilized packaging
  • Clear and comprehensive labeling with batch identification, expiry dates, storage conditions, and handling precautions
• Biocompatibility: Recommendations for evaluation based on ISO 10993 series for medical device biocompatibility assessment on final, set cement material

Applications

Acrylic resin cements standardized under ISO 5833 are widely used in:

• Orthopaedic Implant Fixation: Secure anchoring of prosthetic devices such as hip and knee replacements to bone.
• Surgical Procedures: Where intraoperative mixing and immediate application of bone cement is required for optimal fit and fixation.
• Medical Device Manufacturing: Guiding the design, quality assurance, and validation of sterile, pre-measured bone cement kits for hospital and clinical environments.
• Regulatory Compliance: Demonstrating conformity with recognized international standards to support registration, commercialization, and procurement of acrylic bone cements globally.

Adopting ISO 5833 enhances product reliability and patient safety, ensuring consistent performance across clinical settings.

Related Standards

For a comprehensive quality and regulatory framework, the following standards are closely associated with ISO 5833:

• ASTM F451: Specification for acrylic bone cement, referenced within ISO 5833 for additional technical and testing definitions.
• ISO 10993 Series: Biological evaluation of medical devices, essential for assessing the biocompatibility of implant materials.
• ISO 14644: Cleanroom and contamination control standards, relevant for the preparation and packaging of sterile cements.
• ISO 13485: Quality management systems for medical devices, applicable to manufacturers of surgical implant materials.

Practical Value

Complying with ISO 5833 ensures high standards in the manufacture and clinical use of acrylic resin cements for surgical implants. It provides clear, measurable criteria for product performance, sterility, labeling, and mechanical properties, supporting healthcare providers in delivering safe and effective orthopaedic care. Manufacturers benefit from clear guidance on testing protocols, packaging, and documentation, facilitating regulatory approval and international market access for bone cements used in surgical applications.

By implementing ISO 5833, organizations demonstrate commitment to product quality, patient safety, and regulatory excellence in the field of surgical implant materials.

FINAL DRAFT
International
Standard
ISO/FDIS 5833
ISO/TC 150/SC 1
Implants for surgery — Acrylic resin
Secretariat: DIN
cements
Voting begins on:
Implants chirurgicaux — Ciments à base de résine acrylique 2026-07-09
Voting terminates on:
2026-09-03
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 5833:2026(en) © ISO 2026

FINAL DRAFT
ISO/FDIS 5833:2026(en)
International
Standard
ISO/FDIS 5833
ISO/TC 150/SC 1
Implants for surgery — Acrylic resin
Secretariat: DIN
cements
Voting begins on:
Implants chirurgicaux — Ciments à base de résine acrylique
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 5833:2026(en) © ISO 2026

ii
ISO/FDIS 5833:2026(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Liquid component . 1
4.1 Appearance .1
4.2 Stability .2
4.3 Accuracy of contents .2
5 Powder component . 2
5.1 General .2
5.2 Appearance .2
5.3 Accuracy of contents .2
5.4 Initiator agent concentration . .2
6 Liquid-powder mixture intended for syringe usage . 2
6.1 Setting properties, test methods and requirements .2
6.2 Extrusion .3
7 Liquid-powder mixture intended for use in dough state. 3
7.1 Setting properties, test methods and requirements .3
7.2 Intrusion.3
8 Liquid-powder mixture intended for dual usage (both syringe and dough state usage) . 3
8.1 Setting properties, test methods and requirements .3
8.2 Intrusion and extrusion .3
9 Set and polymerized cement . 4
9.1 General .4
9.2 Monitoring leachable monomer from set and polymerized cement .4
10 Packaging. 4
11 Labelling . 4
11.1 Unit package .4
11.2 Accompanying documentation .5
12 Biocompatibility . 5
12.1 General .5
Annex A (normative) Determination of stability of liquid component . 6
Annex B (normative) Determination of doughing time of liquid-powder mixture of cement
intended for dough usage . 8
Annex C (normative) Determination of maximum temperature and setting time of liquid-
powder mixture . 10
Annex D (normative) Determination of intrusion of liquid-powder mixture of cement intended
for dough usage . 14
Annex E (normative) Determination of compressive strength of polymerized cement . 17
Annex F (normative) Determination of bending modulus and bending strength of polymerized
cement .21
Bibliography .25

iii
ISO/FDIS 5833:2026(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 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;

iv
ISO/FDIS 5833:2026(en)
— 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.

v
FINAL DRAFT International Standard ISO/FDIS 5833:2026(en)
Implants for surgery — Acrylic resin cements
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
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ASTM F451-21, Standard specification for acrylic bone cement
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ASTM F451 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
unit of cement
package containing one pouch or vial of sterile premeasured powder component and one pouch or vial of
sterile premeasured liquid component
Note 1 to entry: For cements in which the radio-opaque agent is supplied separately, the unit of cement includes the
vial or package of premeasured radio-opaque powder component.
4 Liquid component
4.1 Appearance
When inspected by normal or corrected vision, the liquid component shall be free from particles and other
contaminants.
ISO/FDIS 5833:2026(en)
4.2 Stability
The stability test shall be performed as described in Annex A. The flow time of the samples of liquid
component shall not increase by more than 10 %.
4.3 Accuracy of contents
When measured to an accuracy of ±0,1 ml, the volume of the liquid component of each of five units shall be
within 5 % of that stated on the package [see 10.1 b)].
5 Powder component
5.1 General
The powder component includes the polymer particles, initiator agents and, if applicable, the radio-opaque
agent. In some cases, the radio-opaque agent is supplied separately.
5.2 Appearance
When inspected by normal or corrected vision, the powder shall be free from agglomerates and extraneous
material.
5.3 Accuracy of contents
When weighed to an accuracy of ±0,1 g, the mass of the powder component of each of five units shall be
within 5 % of that stated on the package [see 10.1 b)].
The components used for the determinations specified in 4.3 and 5.3 may be used subsequently for other
tests described in this document, with the condition that there is no loss of mass or volume for each cement
component produced and all the requirements of Clause 4 and Clause 5 are met.
5.4 Initiator agent concentration
The concentration of the initiator agent shall be measured. If benzoyl peroxide is used as an initiator, the
amount of dibenzoyl peroxide (BPO) in the powder portion can be determined using the protocol described
in ASTM F451-21, Clause A.1, Clause A.2 or equivalent.
6 Liquid-powder mixture intended for syringe usage
6.1 Setting properties, test methods and requirements
When determined by the methods given in Annexes B, C, E and F, the setting properties and the properties of
the set and polymerized cement shall conform with the values given in Tables 1 and 2.

ISO/FDIS 5833:2026(en)
Table 1 — Requirements and test methods for setting properties of liquid-powder mixtures
Doughing time Setting time Maximum temperature
Maximum Maximum
Test Test Test
Mixture Average deviation Average Average deviation from
method method method
from average average
min min min °C °C
Syringe usage
— — — 6,5 to 15 Annex C 90 °C ±5 Annex C
(see Clause 6)
Dough state
usage (see ≤ 5 1,5 Annex B 3 to 15 Annex C 90 °C ±5 Annex C
Clause 7)
Table 2 — Requirements and test methods for set and polymerized cement
Test Requirement Test method
Compressive strength ≥ 70 MPa Annex E
Bending modulus ≥ 1 800 MPa Annex F
Bending strength ≥ 50 MPa Annex F
6.2 Extrusion
The manufacturer shall evaluate the viscosity profile of the cement during its curing process using the test
method(s) described in ASTM F451-21, 7.9.1 (extrusion, capillary viscosity) or 7.9.2 (extrusion, rotational
shear viscosity), or both.
7 Liquid-powder mixture intended for use in dough state
7.1 Setting properties, test methods and requirements
When determined by the methods given in Annexes B, C, D, E and F, the setting properties and the properties
of the set and polymerized cement shall conform with the values given in Tables 1 and 2.
7.2 Intrusion
The intrusion test shall by performed as described in Annex D. The average intrusion of at least one sample
shall be not less than 2 mm.
8 Liquid-powder mixture intended for dual usage (both syringe and dough state
usage)
8.1 Setting properties, test methods and requirements
When determined by the methods given in Annexes B, C, D, E and F, the setting properties and the properties
of the set and polymerized cement shall conform with the values given in Tables 1 and 2.
8.2 Intrusion and extrusion
If the mixture is to be used as a dual usage cement, then both intrusion and extrusion tests shall be
performed and shall conform to the requirements in 6.2 and 7.2.

ISO/FDIS 5833:2026(en)
9 Set and polymerized cement
9.1 General
Table 2 presents the requirements and test methods for set and polymerized cement, which is also known as
cured cement.
9.2 Monitoring leachable monomer from set and polymerized cement
Leaching monomer from set and polymerized cement shall be measured and monitored in accordance with
ASTM F451-21, Clause A.5.
10 Packaging
10.1 Each component of the cement shall be packaged and sterilized separately using a suitable method.
The liquid component shall be sterilized by ultrafiltration prior to being filled into an aseptic container. Each
component shall be packaged in a double-layer sealed container. The components of a single unit of cement
shall be further packaged in a container that shall contain the accompanying documentation as described in
11.2 and shall present the information as described in 11.1.
Each component of the cement shall be packaged and sterilized in a double-layer sealed container and then
packaged in an outer container which shall contain the accompanying documentation.
10.2 In the case of cement being sold with two cement units per container, the requirements of 10.1 shall
apply.
10.3 The materials of the package should not contaminate or permit contamination of the contents. The
packaging should prevent damage to, or leakage of, the contents during transit and storage and should be
designed so that it is easy to open and facilitates aseptic presentation of the contents.
11 Labelling
11.1 Unit package
At least the following information shall appear on the unit package of each cement unit:
a) a reference to this document, i.e. ISO/FDIS 5833:2026;
b) a description of the contents, including the mass of the powder component and the mass or volume of
the liquid component, and the generic names of the constituents;
c) the name and address of the manufacturer, and the supplier if different from the manufacturer;
d) a warning that the package contains flammable liquid;
e) a statement that the contents are sterile and a warning against the use of an opened or damaged
package;
f) an instruction to store the package at a temperature below 25 °C and away from strong light;
g) the batch or lot numbers of the liquid and the powder component and the expiry date of the material;
ensure that all individual components of cement are clearly identified and with an expiry date in
addition to the entire package.
NOTE Legal requirements for labelling can apply in some countries.

ISO/FDIS 5833:2026(en)
11.2 Accompanying documentation
The following information in a) to h) shall at least appear on the accompanying documentation (see Clause 9)
[the information in i) is recommended only]:
a) instructions for handling the components and preparing the cement for use, including details of the
equipment needed and an instruction to mix the entire contents of the cement component packages (i.e.
the powder and liquid components in a unit of cement shall be used together and not used separately);
the instructions shall emphasize the importance of minimizing the entrapment of air;
b) instructions and recommendations for using the cement, including necessary precautions, and drawing
attention to the expiry date marked on the package;
c) a statement drawing attention to the toxic, hazardous and irritant properties associated with the
handling and use of the components and the cement;
d) a statement that high ambient or component temperatures will decrease, and low ambient or component
temperatures will increase, the doughing, working and setting times of the cement;
e) whether the cement is intended for use with a syringe or in the dough state, or both (dual usage);
f) the relative proportions of the powder and liquid components, expressed as a percent mass or volume
fraction;
g) a warning against re-sterilization of either the powder or liquid components;
h) a statement that, once opened, any pack should be completely used or discarded and not retained for use
on a later occasion;
i) in addition, it is recommended to include a graphical or tabular representation of the effect of
temperature on the length of the phases in cement curing, prepared from experimental data on the
particular brand and type of cement.
12 Biocompatibility
12.1 General
[1],[2]
The biocompatibility of acrylic bone cement has been reported in the literature . While no known
surgical implant material has ever been shown to cause absolutely no adverse reactions in the human
body, long-term clinical experience and laboratory studies 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. When new applic
...

ISO/FDIS 5833:2026(en)
ISO/TC 150/SC 1/WG 4
Secretariat: DIN
Date: 2026-06-24
Implants for surgery — Acrylic resin cements
Date: 2026-04-20
Implants chirurgicaux — Ciments à base de résine acrylique
FDIS stage
DRAFT International Standard ISO/DIS 5833:2026(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
Fax: [phone]
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ISO/DISFDIS 5833:2026(en)
Contents
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Liquid component . 1
4.1 Appearance . 1
4.2 Stability . 2
4.3 Accuracy of contents . 2
5 Powder component . 2
5.1 General . 2
5.2 Appearance . 2
5.3 Accuracy of contents . 2
5.4 Initiator agent concentration . 2
6 Liquid-powder mixture intended for syringe usage . 2
6.1 Setting properties, test methods and requirements . 2
6.2 Extrusion . 3
7 Liquid-powder mixture intended for use in dough state . 3
7.1 Setting properties, test methods and requirements . 3
7.2 Intrusion . 3
8 Liquid-powder mixture intended for dual usage (both syringe and dough state usage) . 3
8.1 Setting properties, test methods and requirements . 3
8.2 Intrusion and extrusion . 4
9 Set and polymerized cement . 4
9.1 General . 4
9.2 Monitoring leachable monomer from set and polymerized cement . 4
10 Packaging . 4
11 Labelling . 4
11.1 Unit package . 4
11.2 Accompanying documentation . 5
12 Biocompatibility . 5
12.1 General . 5
Annex A (normative) Determination of stability of liquid component . 6
Annex B (normative) Determination of doughing time of liquid-powder mixture of cement
intended for dough usage . 8
Annex C (normative) Determination of maximum temperature and setting time of liquid-
powder mixture . 10
Annex D (normative) Determination of intrusion of liquid-powder mixture of cement intended
for dough usage . 15
Annex E (normative) Determination of compressive strength of polymerized cement . 19
Annex F (normative) Determination of bending modulus and bending strength of polymerized
cement . 24
Bibliography . 29

iii
ISO/FDIS 5833:2026(en)
Inhalt
iv
ISO/DISFDIS 5833:2026(en)
v
ISO/FDIS 5833:2026(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 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;
— — the terms and definitions of ASTM F451 hashave been cited in Clause 3Clause 3;;
— subclause 5.4— 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— Clauses 6 and 77 have been revised and a new Clause 8Clause 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 6.2Clause 6.2;;
— — a clarification for when to perform an intrusion test has been added to 7.2Clause 7.2;;
— — a clarification for when to perform both an intrusion and extrusion test has been added to 8.28.2;;
vi
ISO/DISFDIS 5833:2026(en)
— subclause 9.2— 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 12Clause 12 was has been added on biocompatibility;
— — the reporting sections in all Annexes werehave been revised;
— — bibliographical references have been added bibliography.
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.
Field Code Changed
vii
ISO/FDIS 5833:2026(en)
Implants for surgery — Acrylic resin cements
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 teststest methods are intended to be performed on, thea
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
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ASTM F451-21, Standard Specificationspecification for Acrylic Bone Cementacrylic bone cement
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ASTM F451 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/
3.1 3.1
unit of cement
package containing one pouch or vial of sterile premeasured powder component and one pouch or vial of
sterile premeasured liquid component
Note 1 to entry: For cements in which the radio-opaque agent is supplied separately, the unit of cement includes the vial
or package of premeasured radio-opaque powder component.
4 Liquid component
4.1 Appearance
When inspected by normal or corrected vision, the liquid component shall be free from particles and other
contaminants.
ISO/FDIS 5833:2026(en)
4.2 Stability
The stability test shall be performed as described in Annex AAnnex A. The flow time of the samples of liquid
component shall not increase by more than 10 %.
4.3 Accuracy of contents
When measured to an accuracy of ±0,1 ml, the volume of the liquid component of each of five units shall be
within 5 % of that stated on the package [see 10.110.1 b)].
5 Powder component
5.1 General
The powder component includes the polymer particles, initiator agents and, if applicable, the radio-opaque
agent. In some cases, the radio-opaque agent is supplied separately.
5.2 Appearance
When inspected by normal or corrected vision, the powder shall be free from agglomerates and extraneous
material.
5.3 Accuracy of contents
When weighed to an accuracy of ±0,1 g, the mass of the powder component of each of five units shall be within
5 % of that stated on the package [see 10.110.1 b)].
The components used for the determinations specified in 4.34.3 and 5.35.3 may be used subsequently for
other tests described in this document, with the condition that there is no loss of mass or volume for each
cement component produced, and all the requirements of Clause 4Clause 4 and Clause 5Clause 5 are
satisfiedmet.
5.4 Initiator agent concentration
The concentration of the initiator agent shall be measured. If benzoyl peroxide is used as an initiator, the
amount of dibenzoyl peroxide (BPO) in the powder portion can be determined using the protocol described
in ASTM F451-21, Clause A.1, Clause A.2 or equivalent.
6 Liquid-powder mixture intended for syringe usage
6.1 Setting properties, test methods and requirements
When determined by the methods given in Annexes B, CAnnexes B, C, E, E and FF,, the setting properties and
the properties of the set and polymerized cement shall conform with the values given in Tables 1Tables 1 and
22.
ISO/FDIS 5833:2026(en)
Table 1 — Requirements and test methods for setting properties of liquid-powder mixtures
Doughing time Setting time Maximum temperature
Maximum Maximum
deviation Test Test deviation Test
Mixture Average Average Average
from method method from method
average average
min min  min  °C °C
Syringe usage
(see Annex C Annex C
— — — 6,5 to 15 90 °C ±5
Clause 6Claus Annex C Annex C
e 6))
Dough state
usage (see Annex BA Annex C Annex C
≤ 5 1,5 3 to 15 90 °C ±5
Clause 7Claus nnex B Annex C Annex C
e 7))
Table 2 — Requirements and test methods for set and polymerized cement
Test Requirement Test method
Compressive strength ≥ 70 MPa Annex EAnnex E
Bending modulus ≥ 1 800 MPa Annex FAnnex F
Bending strength ≥ 50 MPa Annex FAnnex F
6.2 Extrusion
The manufacturer shall evaluate the viscosity profile of the cement during its curing process using the ASTM
F451-21 test method(s) described in eitherASTM F451-21, 7.9.1 (Extrusionextrusion, capillary viscosity) or
7.9.2 (Extrusionextrusion, rotational shear viscosity), or both.
7 Liquid-powder mixture intended for use in dough state
7.1 Setting properties, test methods and requirements
When determined by the methods given in Annexes B, C, DAnnexes B, C, D, E, E and FF,, the setting properties
and the properties of the set and polymerized cement shall conform with the values given in Tables 1Tables 1
and 22.
7.2 Intrusion
The intrusion test shall by performed as described in Annex DAnnex D. The average intrusion of at least one
sample shall be not less than 2 mm.
8 Liquid-powder mixture intended for dual usage (both syringe and dough state
usage)
8.1 Setting properties, test methods and requirements
When determined by the methods given in Annexes B, C, DAnnexes B, C, D, E, E and FF,, the setting properties
and the properties of the set and polymerized cement shall conform with the values given in Tables 1Tables 1
and 22.
ISO/FDIS 5833:2026(en)
8.2 Intrusion and extrusion
If the mixture is to be used as a dual usage cement, then both intrusion and extrusion tests shall be performed
and shall conform to the requirements in 6.2Clauses 6.2 and 7.27.2.
9 Set and polymerized cement
9.1 General
Table 2Table 2 presents the requirements and test methods for set and polymerized cement, which is also
known as cured cement.
9.2 Monitoring leachable monomer from set and polymerized cement
Leaching monomer from set and polymerized cement shall be measured and monitored in accordance with
ASTM F451-21, Clause A.5.
10 Packaging
10.1 10.1 Each component of the cement shall be packaged and sterilized separately using a suitable
method. The liquid component shall be sterilized by ultrafiltration prior to being filled into an aseptic
container. Each component shall be packaged in a double-layer sealed container. The components of a single
unit of cement shall be further packaged in a container that shall contain the accompanying documentation as
described in 11.211.2 and shall present the information as described in 11.111.1.
Each component of the cement shall be packaged and sterilized in a double-layer sealed container and then
packaged in an outer container which shall contain the accompanying documentation.
10.2 10.2 In the case of cement being sold with two cement units per container, the requirements of
10.110.1 shall apply.
10.3 10.3 The materials of the package should not contaminate or permit contamination of the contents.
The packaging should prevent damage to, or leakage of, the contents during transit and storage and should be
designed so that it is easy to open and facilitates aseptic presentation of the contents.
11 Labelling
11.1 Unit package
At least the following information shall appear on the unit package of each cement unit:
a) a reference to this document, i.e. ISO/FDIS 5833:2026;
b) a description of the contents, including the mass of the powder component and the mass or volume of the
liquid component, and the generic names of the constituents;
c) the name and address of the manufacturer, and the supplier if different from the manufacturer;
d) a warning that the package contains flammable liquid;
e) a statement that the contents are sterile and a warning against the use of an opened or damaged package;
f) an instruction to store the package at a temperature below 25 °C and away from strong light;
ISO/FDIS 5833:2026(en)
g) the batch or lot numbers of the liquid and the powder component and the expiry date of the material.
Ensure; ensure that all individual components of cement are clearly identified and with an expiry date in
addition to the entire package.
NOTE Legal requirements for labelling can apply in some countries.
11.2 Accompanying documentation
At least theThe following information in a) to h) shall at least appear on the accompanying documentation
(see Clause 9Clause 9):) [the information in i) is recommended only]:
a) instructions for handling the components and preparing the cement for use, including details of the
equipment needed and an instruction to mix the entire contents of the cement component packages (i.e.,.
the powder and liquid components in a unit of cement shall be used together and not used separately);
the instructions shall emphasize the importance of minimizing the entrapment of air;
b) instructions and recommendations for using the cement, including necessary precautions, and drawing
attention to the expiry date marked on the package;
c) a statement drawing attention to the toxic, hazardous and irritant properties associated with the handling
and use of the components and the cement;
d) a statement that high ambient or component temperatures will decrease, and low ambient or component
temperatures will increase, the doughing, working and setting times of the cement;
e) whether the cement is intended for use with a syringe or in the dough state, or both (dual usage);
f) the relative proportions of the powder and liquid components, expressed as a percent mass or volume
fraction;
g) a warning against re-sterilization of either the powder or liquid components;
h) a statement that, once opened, any pack should be completely used or discarded and not retained for use
on a later occasion.;
i) Inin addition, it is recommended to include a graphical or tabular representation of the effect of
temperature on the length of the phases in cement curing, prepared from experimental data on the
particular brand and type of cement.

12 12. Biocompatibility
12.1 12.1 General
[1]],[[2]
The biocompatibility of acrylic bone cement has been reported in the literature (1, 2). While no known
surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body,
long-term clinical experience and laboratory studies 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. When new applications of the material, or significant modification to the material or its physical
forms are being considered, an evaluation in accordance with the applicable biocompatibility standards from
the ISO 10993 series should be performed. Any biocompatibility testing should be conducted on the final,
finished device (that is, the set and polymerized cement in accordance withaccording to the instructions for
use).
ISO/FDIS 5833:2026(en)
Annex A
(normative)
Determination of stability of liquid component
A.1 Principle
The flow time (viscosity) of the liquid component is determined before and after accelerated ageing by heating,
and the increase in flow time after heating is calculated. Two units of the liquid component are tested.
A.2 Apparatus
A.2.1 A.2.1 Clean glass U-tube viscometer.
A.2.2 A.2.2 Timing device, with an accuracy of ±0,1 s.
A.2.3 A.2.3 Means of heating test specimens.
A.3 Test conditions
Condition the viscometer and the test specimens at (23 ± 1) °C for at least 1 h before beginning the test.
Perform the viscosity measurements at (23 ± 1) °C.
A.4 Procedure
A.4.1 A.4.1 Fill the viscometer in the usual way with the liquid component.
A.4.2 A.4.2 Record the flow time taken for the meniscus to fall to the equilibrium level (time t ).
a
A.4.3 A.4.3 Heat an aliquot of the liquid component at (60 ± 2) °C for (48 ± 2) h in the dark in a closed
container, allow it to cool to (23 ± 1) °C and to remain at this temperature for at least 1 h.
A.4.4 A.4.4 Repeat A.4.1A.4.1 and A.4.2A.4.2 and record the flow time (time t ).
b
A.4.5 A.4.5 Repeat A.4.1A.4.1 to A.4.4A.4.4 on a second unit of liquid component.
A.5 Calculation and expression of results
Calculate the percentage change in flow time, Δt, for each unit of liquid component using
Formula (A.1)Formula (A.1)::
𝑡𝑡−𝑡𝑡
b a
Δ𝑡𝑡 = ×100 % (A.1)
𝑡𝑡
a
where
Δt is the change of flow time in percent;
ta is the flow time for the meniscus to fall to the equilibrium level at time = = 0;
t is the flow time for the meniscus to fall to the equilibrium level after procedural step in A.4.3A.4.3 (t is to be
b b
recorded in A.4.4A.4.4).).
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