ISO/FDIS 10873
(Main)Dentistry — Denture adhesives
Dentistry — Denture adhesives
This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Le présent document classe les adhésifs pour prothèses dentaires utilisés par les porteurs de prothèses amovibles et spécifie leurs exigences et méthodes d'essai. Il spécifie également les exigences par rapport aux instructions devant être fournies pour l'utilisation de ces produits. Le présent document s’applique aux adhésifs pour prothèses dentaires amovibles destinés à être utilisés par le consommateur et exclut les produits pour intrados de prothèse spécifiés ou appliqués par les professionnels dentaires. Pour l’évaluation des éventuels risques biologiques, il est recommandé de se reporter à l’ISO 7405 et à l’ISO 10993‑1.
General Information
- Status
- Not Published
- Technical Committee
- ISO/TC 106/SC 7 - Oral care products
- Drafting Committee
- ISO/TC 106/SC 7/WG 9 - Dentures adhesives
- Current Stage
- 5000 - FDIS registered for formal approval
- Start Date
- 12-Dec-2025
- Completion Date
- 09-Oct-2025
Relations
- Effective Date
- 16-Mar-2024
- Effective Date
- 14-Oct-2023
Overview
ISO/FDIS 10873:2025 is an international standard established by the International Organization for Standardization (ISO) that addresses denture adhesives used by consumers who wear removable dentures. This standard classifies denture adhesives, specifies essential requirements and test methods, and defines the necessary user instructions for these products. ISO 10873 focuses exclusively on consumer-use denture adhesives, distinctly excluding dental lining materials prescribed or applied by dental professionals. The third edition of the standard refines previous versions by updating requirements and removing the pH value specification to reflect current best practices.
Denture adhesives play a vital role in improving the retention and stability of removable dentures on soft supporting tissues. ISO/FDIS 10873 ensures that adhesives meet reliable safety, quality, and performance parameters, contributing to improved user confidence and comfort.
Key Topics
Classification: The standard classifies denture adhesives into two main types:
- Glue type: Powder, cream, sheet, or tape form with water-soluble polymers as the adhesive base.
- Liner type: Non-aqueous denture adhesives.
Requirements: It defines rigorous requirements related to physical and chemical properties essential for the adhesives’ effectiveness and safety.
Test Methods: Comprehensive testing protocols include:
- Stability and aging procedures to assess durability.
- Washability tests for glue-type adhesives.
- Multiple adhesion strength tests tailored to adhesive type.
- Peeling and consistency tests specifically for liner-type adhesives.
Sampling: Guidelines on representative sampling are included to ensure product uniformity.
Packaging and Labelling: Measures ensure that denture adhesives are packaged securely and labelled clearly, facilitating safe and effective consumer use.
Instructions for Use: Detailed instructions must accompany products, guiding consumers on correct application and usage.
Applications
ISO/FDIS 10873:2025 serves as a critical reference for:
Manufacturers and Suppliers: Ensuring denture adhesives comply with international quality and performance standards to meet consumer needs.
Regulatory Bodies: Facilitating product assessment and market surveillance with standardized test methods and classifications.
Retailers and Distributors: Verifying product compliance and accurate labelling to inform customers effectively.
Consumers: Providing confidence in the safety and efficacy of over-the-counter denture adhesives, enabling proper usage for improved denture retention.
This standard ultimately enhances the reliability and user experience of removable denture adhesives by promoting harmonized global minimum requirements and testing protocols.
Related Standards
- ISO 1942: Dentistry - Vocabulary: Defines terminology relevant to dental products including denture adhesives.
- ISO 7405: Evaluation of biocompatibility of medical devices used in dentistry: Assesses biological safety considerations relevant to dental materials.
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: Guides biological risk assessment, recommended for complementary review alongside ISO 10873 when evaluating possible hazards.
- ISO 3696: Water for analytical laboratory use - Specification and test methods: Specifies water quality for use in testing protocols.
- ISO 7823-2: Plastics - Poly(methyl methacrylate) sheets: Related to denture base materials, affecting adhesive compatibility.
- ISO 8601-1: Date and time - Representations for information interchange - Part 1: Basic rules: Applies to date formatting on labelling for traceability.
By adhering to ISO/FDIS 10873, stakeholders in the dental products market can ensure denture adhesives are developed, tested, and supplied to deliver safe, consistent, and effective solutions tailored for removable denture wearers worldwide.
Frequently Asked Questions
ISO/FDIS 10873 is a draft published by the International Organization for Standardization (ISO). Its full title is "Dentistry — Denture adhesives". This standard covers: This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.
This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.
ISO/FDIS 10873 is classified under the following ICS (International Classification for Standards) categories: 71.100.70 - Cosmetics. Toiletries. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/FDIS 10873 has the following relationships with other standards: It is inter standard links to ISO 12571:2021, ISO 10873:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO/FDIS 10873 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/TC 106/SC 7
Dentistry — Denture adhesives
Secretariat: JISC
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Voting begins on:
2026-01-29
Voting terminates on:
2026-03-26
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
ISO/CEN PARALLEL PROCESSING 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
FINAL DRAFT
International
Standard
ISO/TC 106/SC 7
Dentistry — Denture adhesives
Secretariat: JISC
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Voting begins on:
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
ISO/CEN PARALLEL PROCESSING
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 General .2
4.2 Types and classes .2
5 Requirements . 2
5.1 General .2
5.1.1 Biocompatibility .2
5.1.2 Microbiology .2
5.1.3 Stability .2
5.2 Specific requirements for Type 1 adhesives .2
5.2.1 Washability.2
5.2.2 Strength of the adhesion to the prosthesis .2
5.3 Specific requirements for Type 2 adhesives .2
5.3.1 Adhesion strength .2
5.3.2 Peeling property .3
5.3.3 Consistency .3
6 Sampling . 3
7 Measurements and test methods . 3
7.1 Test conditions .3
7.2 Determination of stability — Aging procedure .3
7.3 Test of washability (for Type 1 adhesives) .3
7.3.1 Apparatus and materials .3
7.3.2 Reagent .3
7.3.3 Procedure .3
7.4 Adhesion strength test I (for Type 1 adhesives) .3
7.4.1 General .3
7.4.2 Apparatus .4
7.4.3 Procedure .5
7.5 Adhesion strength test II (for Type 1 adhesives) .7
7.5.1 General .7
7.5.2 Apparatus .7
7.5.3 Procedure .7
7.6 Adhesion strength test (for Type 2 adhesives) .8
7.6.1 Apparatus .8
7.6.2 Procedure .9
7.7 Peeling test (for Type 2 adhesives) .9
7.7.1 Apparatus and materials .9
7.7.2 Reagent .10
7.7.3 Procedure .10
7.8 Consistency test (for Type 2 adhesives) .10
7.8.1 Apparatus .10
7.8.2 Procedure . 12
7.9 Assessment . 12
8 Packaging.12
9 Accompanying information .12
9.1 Information to be included in the instructions for use . 12
9.2 Labelling on the package . 13
iii
Bibliography . 14
iv
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 documents 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 106, Dentistry, Subcommittee SC 7, Oral care
products, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 10873:2021), which has been technically
revised.
The main changes are as follows:
— the requirement for pH value (5.1.2) has been deleted;
— pH value measurement (7.2) has been deleted.
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
Introduction
Denture adhesives are used to improve the retention stability of removable dentures to soft supporting
tissues temporarily. This document is intended to determine the physical and chemical properties of denture
adhesives.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included
in this document. It is recommended that, in assessing possible biological hazards, reference be made to
ISO 7405 and ISO 10993-1.
vi
FINAL DRAFT International Standard ISO/FDIS 10873:2026(en)
Dentistry — Denture adhesives
1 Scope
This document classifies denture adhesives used by wearers of removable dentures. It also specifies
requirements, test methods and instructions to be supplied for the use of such products.
This document is applicable to denture adhesives for use by the consumer and excludes the dental lining
materials prescribed or applied by dental professionals.
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.
ISO 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7823-2, Plastics — Poly(methyl methacrylate) sheets — Types, dimensions and characteristics — Part 2:
Extruded sheets
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 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
denture adhesive
dental product placed on the intaglio surface of a removable denture to temporarily improve its retention to
soft supporting tissues
Note 1 to entry: The intaglio surface is also known as the fitting surface.
[SOURCE: ISO 1942:2020, 3.3.1.23, modified — Note 1 to entry has been added.]
3.2
glue type
denture adhesive (3.1) in powder, cream, sheet or tape form with a water-soluble polymer as the adhesive
constituent
3.3
liner type
denture adhesive (3.1) in non-aqueous form
4 Classification
4.1 General
For the purposes of this document, denture adhesives are categorized as one of the following types:
4.2 Types and classes
a) Type 1: glue type:
— Class 1: powder form;
— Class 2: cream form;
— Class 3: sheet or tape form.
b) Type 2: liner type.
5 Requirements
5.1 General
5.1.1 Biocompatibility
Particular attention should be given to assessing the effects on biocompatibility from the release of metallic
ions from the denture adhesive.
5.1.2 Microbiology
Some information concerning the testing for microbiological contamination can be found in ISO 16212,
ISO 18415, ISO 18416, ISO 21148, ISO 21149, ISO 21150, ISO 22717, ISO 22718, ISO 29621 and References [12]
to [15].
5.1.3 Stability
The denture adhesive shall show no signs of deterioration which can affect conformity with this document
after being subjected to one of the aging procedures specified in 7.2.
5.2 Specific requirements for Type 1 adhesives
5.2.1 Washability
There shall be no residual lump on the poly (methyl methacrylate) (PMMA) plate surface when tested in
accordance with 7.3.
5.2.2 Strength of the adhesion to the prosthesis
Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.4 and 7.5.
5.3 Specific requirements for Type 2 adhesives
5.3.1 Adhesion strength
Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.6.
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Dentistry — Denture adhesives
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ISO/FDIS 10873 (Ed.3:2026(en)
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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, Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers
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'sISO’s member body in the country of the requester.
ISO Copyright Office copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Formatted: zzCopyright address, Adjust space between Latin
Phone: + 41 22 749 01 11
and Asian text, Adjust space between Asian text and
numbers
Email: copyright@iso.org
Formatted: French (Switzerland)
E-mail: copyright@iso.org Formatted: French (Switzerland)
Website: www.iso.org www.iso.org
Formatted: Italian (Italy)
Formatted: Italian (Italy)
Published in Switzerland.
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and Asian text, Adjust space between Asian text and
numbers
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Line spacing: single, Tab stops: Not at 17.2 cm
ii © ISO 2023 – All rights reserved
ii
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Contents
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Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification. 2
5 Requirements . 2
6 Sampling . 3
7 Measurements and test methods . 3
8 Packaging . 23
9 Accompanying information . 23
Bibliography . 25
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification. 2
4.1 General. 2
4.2 Types and classes . 2
5 Requirements . 2
5.1 General. 2
5.2 Specific requirements for Type 1 adhesives . 2
5.3 Specific requirements for Type 2 adhesives . 3
6 Sampling . 3
7 Measurements and test methods . 3
7.1 Test conditions . 3
7.2 Determination of stability — Aging procedure . 4
7.3 Test of washability (for Type 1 adhesives) . 4
7.4 Adhesion strength test I (for Type 1 adhesives) . 5
7.5 Adhesion strength test II (for Type 1 adhesives) . 9
7.6 Adhesion strength test (for Type 2 adhesives) . 11
7.7 Peeling test (for Type 2 adhesives) . 12
7.8 Consistency test (for Type 2 adhesives) . 13
7.9 Assessment . 15
8 Packaging . 16 Formatted: Font: 11 pt
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9 Accompanying information . 16
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iii
ISO/FDIS 10873 (Ed.3:2026(en)
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9.1 Information to be included in the instructions for use . 16
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9.2 Labelling on the package . 17
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Bibliography . 18
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iv © ISO 2023 – All rights reserved
iv
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Foreword
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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 documents 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)
Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers
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 106, Dentistry, Subcommittee SC 7, Oral care
products, in collaboration with the European Committee for Standardization (CEN) Technical Committee Formatted: Font: Not Italic
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
Formatted: Font: Not Italic
(Vienna Agreement).
Formatted: Font: Not Italic
This third edition cancels and replaces the second edition (ISO 10873:2021), which has been technically
Formatted: Default Paragraph Font
revised. The main changes compared to the previous edition are as follows:
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
— The main changes are as follows:
— the requirement for pH value (5.1.2) has been deleted, and;
Formatted: English (United Kingdom)
— pH value measurement (7.2) has been deleted.
Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers, Tab stops:
Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
Any feedback or questions on this document should be directed to the user’s national standards body. A
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
complete listing of these bodies can be found at www.iso.org/members.html.
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Formatted: English (United Kingdom)
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v
ISO/FDIS 10873 (Ed.3:2026(en)
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Formatted: Font: Bold
Formatted: Font: Bold
Introduction
Formatted: HeaderCentered, Line spacing: single, Tab stops:
Not at 11.11 cm
Denture adhesives are used forto improve the improvement in retention stability of removable
denturedentures to soft supporting tissues temporarily. This document is intended to determine the physical
and chemical properties of denture adhesives.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
document. It is recommended that, in assessing possible biological hazards, reference be made to ISO 7405 Formatted: Default Paragraph Font
and ISO 10993-1.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
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Formatted: Tab stops: Not at 2.71 cm
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vi © ISO 2023 – All rights reserved
vi
INTERNATIONAL STANDARD FDIS 10873 (Ed.3)
Formatted: Font: (Asian) Japanese
Dentistry — Denture adhesives
Formatted: Font: (Asian) Japanese
1 Scope
Formatted: Main Title 1, Adjust space between Latin and
Asian text, Adjust space between Asian text and numbers
This document classifies denture adhesives used by wearers of removable dentures; it. It also specifies
Formatted: Default Paragraph Font
requirements, test methods and instructions to be supplied for the use of such products.
Formatted: Default Paragraph Font
This document is applicable to denture adhesives for use by the consumer and excludes the dental lining
Formatted: Default Paragraph Font
materials prescribed or applied by dental professionals.
Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers, Tab stops:
2 Normative references
Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
The following documents are referred to in the text in such a way that some or all of their content constitutes
Formatted: Default Paragraph Font
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.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO 1942, Dentistry — Vocabulary
Formatted: Default Paragraph Font
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO 7823-2, Plastics — Poly (methyl methacrylate) sheets — Types, dimensions and characteristics — Part 2:
Extruded sheets
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
Formatted: Default Paragraph Font
3 Terms and definitions
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
Formatted: Default Paragraph Font
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
Formatted: Default Paragraph Font
Formatted: Adjust space between Latin and Asian text,
— — ISO Online browsing platform: available at https://www.iso.org/obp
Adjust space between Asian text and numbers
— IEC Electropedia: available at https://www.electropedia.org/ Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
3.1
Formatted: TermNum2, Adjust space between Latin and
denture adhesive
Asian text, Adjust space between Asian text and numbers
dental product placed on the intaglio surface of a removable denture to temporarily improve its retention to
soft supporting tissues
Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers, Tab stops:
Note 1 to entry: The intaglio surface is also known as the fitting surface. Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
[SOURCE: ISO 1942:2020, 3.3.1.23, modified — Note 1 to entry has been added.]
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3.2
glue type
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denture adhesive (3.1) in powder, cream, sheet or tape form with a water-soluble polymer as the adhesive
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constituent
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ISO/FDIS 10873 (Ed.3:2026(en)
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3.3 3.3
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liner type
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denture adhesive (3.1) in non-aqueous form
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4 Classification
4.1 General
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For the purposes of this document, denture adhesives are categorized as one of the following types:
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4.2 Types and classes
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a) Type 1: glue type:
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— Class 1: powder form;
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— Class 2: cream form; … + Start at: 1 + Alignment: Left + Aligned at: 0 cm + Indent
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— Class 3: sheet or tape form.
0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2 cm + 4.9
cm + 5.6 cm + 6.3 cm + 7 cm
b) Type 2: liner type.
5 Requirements Formatted: Adjust space between Latin and Asian text,
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5.1 General
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5.1.1 Biocompatibility
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Particular attention should be given to assessing the effects on biocompatibility from the release of metallic
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ions from the denture adhesive.
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5.1.2 Microbiology
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Some information concerning the testing for microbiological contamination can be found in ISO 16212, ISO
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18415, ISO 18416, ISO 21148, ISO 21149, ISO 21150, ISO 22717, ISO 22718, ISO 29621 and References [12]
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to [15].
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5.1.3 Stability
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The denture adhesive shall show no signs of deterioration which maycan affect conformity with this document
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after being subjected to one of the aging procedures specified in 7.2.
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5.2 Specific requirements for Type 1 adhesives
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5.2.1 Washability
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There shall be no residual lump on the poly (methyl methacrylate) (PMMA) plate surface when tested in Formatted
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accordance with 7.3.
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5.2.2 Strength of the adhesion to the prosthesis
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Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.4 and 7.5.
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2 © ISO 2023 – All rights reserved
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5.3 Specific requirements for Type 2 adhesives
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5.3.1 Adhesion strength
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Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.6. Formatted
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5.3.2 Peeling property
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There shall be no residual lump on the PMMA plate surface when tested in accordance with 7.7.
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5.3.3 Consistency .
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Consistency shall not be less than 15 mm when tested in accordance with 7.8.
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6 Sampling
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The sample shall be taken from one lot and shall be sufficient to complete all tests specified in Clause 7.
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7 Measurements and test methods
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7.1 Test conditions
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All tests shall be conducted at a temperature of (23 ± 3) °C.
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7.2 Determination of stability — Aging procedure
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Store the denture adhesives in their original containers at (40 ± 2) °C at (75 ± 5) % relative humidity for
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3 months or at such conditions of time and temperature as will simulate storage at room temperature for
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[16] .
30 months .
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7.3 Test of washability (for Type 1 adhesives)
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7.3.1 Apparatus and materials
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7.3.1.1 Water bath, capable of being maintained at a temperature of (37 ± 2) °C.
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7.3.1.2 Poly (methyl methacrylate) (PMMA) plate, approximately 50 mm × 50 mm, shall be in
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accordance with ISO 7823-2.
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7.3.2 Reagent
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7.3.2.1 Water, shall be of grade 3 in accordance with ISO 3696:1987.
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7.3.3 Procedure
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Apply the denture adhesive on the PMMA plate (7.3.1.2) evenly following the manufacturer's instructions for
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use and immerse the plate in water for 1 h in the water bath (7.3.1.1) maintained at (37 ± 2) °C.
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Wash the PMMA plate following the manufacturer's instructions for use and inspect the PMMA plate surface
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with the naked eye, without magnification, for residual denture adhesives. Repeat the tests to obtain five test
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results.
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ISO/FDIS 10873 (Ed.3:2026(en)
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7.4 Adhesion strength test I (for Type 1 adhesives)
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7.4.1 General
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Conduct the adhesion strength test within 3 min after removal from the water bath.
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7.4.2 Apparatus
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7.4.2.1 Adhesion test instrument, having a sample stand, of capacity up to 10 N (for both frame and load
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cell), with a cross-head speed up to 5 mm/min. See Figure 1.
numbers
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7.4.2.2 Sample holder I, having a hole with a diameter of (22 ± 1) mm, depth of (0,5 ± 0,1) mm and a
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surface roughness of 2,0 μm and below, made of poly (methyl methacrylate)PMMA conforming with
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ISO 7823-2. See Figure 2 a).
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After testing, detergent solution is recommended to remove the denture adhesive left on the sample holder
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surface.
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numbers, Tab stops: Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8
7.4.2.3 Sample holder II, having a raised circular part with a diameter of (22 ± 1) mm, a height of
cm + 3.5 cm + 4.2 cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
(5,0 ± 0,1) mm and a surface roughness of 2,0 μm and below, made of poly (methyl methacrylate)PMMA
conforming with ISO 7823-2. See Figure 2 b).
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After testing, detergent solution is recommended to remove the denture adhesive left on the sample holder
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surface.
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7.4.2.4 Pressure sensitive shaft, having a circular base with a diameter of (20,0 ± 0,5) mm, made of poly
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(methyl methacrylate)PMMA conforming with ISO 7823-2. See Figure 3.
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Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
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4 © ISO 2023 – All rights reserved
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ISO/FDIS 10873 (Ed.3:2026(en)
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Key
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1 load detecting part Adjust space between Asian text and numbers, Tab stops:
Not at 0.7 cm + 1.4 cm + 2.1 cm + 2.8 cm + 3.5 cm + 4.2
2 pressure sensitive shaft
cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
3 denture adhesive
4 sample holder
5 sample stand
1 load detecting part
2 pressure sensitive shaft
3 denture adhesive
4 sample holder
5 sample stand
Figure 1 — Adhesion test instrument
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6 © ISO 2023 – All rights reserved
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Dimensions in millimetres
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cm + 4.9 cm + 5.6 cm + 6.3 cm + 7 cm
Formatted Table
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numbers
a) Sample holder I b) Sample holder II
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Figure 2 — Sample holders
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7.4.3 Procedure
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7.4.3.1 Class 1 denture adhesive
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Add water (7.3.2.1) to a Class 1 denture adhesive powder in 1one part classClass 1 denture adhesive with
4four parts water and mix them homogeneously. Leave the mixture in a sealed container for 5 min before
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using it as a specimen. and Asian text, Adjust space between Asian text and
numbers
Slightly overfill the hole of holder I (7.4.2.2) with the specimen, level the surface, and then immerse the
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sample/sample holder I assembly in (300 ± 10) ml of water (7.3.2.1) for 1 min in the water bath (7.3.1.1)
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maintained at (37 ± 2) °C. Take out the sample/sample holder I assembly from the water bath and shake it
once to remove water from the surface. Set the sample/sample holder I assembly on the sample stand of the
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adhesion test instrument (7.4.2.1) so that the load is applied to the centre of the sample. spacing: single, Tab stops: Not at 17.2 cm
ISO/FDIS 10873 (Ed.3:2026(en)
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Apply a load up to (10,0 ± 0,2) N at cross-head speed of 5 mm/min by the pressure sensitive shaft (7.4.2.4) to
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the sample, maintain the load in the position for 30 s and pull it toward the opposite direction at cross-head
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speed of 5 mm/min. Record the maximum force measured by the pressure sensitive shaft and calculate the
force per unit area as the adhesion strength. See Figure 3 a). Repeat the test four times to obtain five results.
7.4.3.2 Class 2 denture adhesive
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Slightly overfill the hole of the sample holder I (7.4.2.2) with a Class 2 denture adhesive, level the surface, and
then immerse the sample/sample holder I assembly in (300 ± 10) ml of water (7.3.2.1) for 1 min in the water
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bath (7.3.1.1) maintained at (37 ± 2) °C. Take out the sample/sample holder I assembly and shake it once to
and Asian text, Adjust space between Asian text and
remove water from the surface. Set the sample/sample holder I assembly on the sample stand of the adhesion
numbers
test instrument (7.4.2.1) so that the load is applied to the centre of the sample.
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Apply a load up to (10,0 ± 0,2) N at cross-head speed of 5 mm/min by the pressure sensitive shaft (7.4.2.4) to
the sample, maintain the load in the position for 30 s and pull it toward the opp
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