SIST EN ISO 10873:2026
(Main)Dentistry - Denture adhesives (ISO 10873:2026)
- Abstract
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.
- Status
- Published
- Public Enquiry End Date
- 27-May-2025
- Publication Date
- 13-Jul-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 09-Jul-2026
- Due Date
- 13-Sep-2026
- Completion Date
- 14-Jul-2026
SIST EN ISO 10873:2026 specifies a classification, requirements, test methods and user information for denture adhesives used by wearers of removable dentures. It is the Slovenian adoption of EN ISO 10873:2026, identical to ISO 10873:2026, and it applies to consumer denture adhesives while excluding dental lining materials prescribed or applied by dental professionals. In practice, it tells manufacturers, test laboratories and buyers how to describe, test and label these products.
What does SIST EN ISO 10873:2026 specify?
SIST EN ISO 10873:2026 covers denture adhesives for consumer use and sets out how to classify them, what performance they must meet, how to test them, and what instructions and label information must accompany them. The scope is limited to adhesives used on removable dentures.
The document is organized into the following main parts:
- Clause 1 - Scope
- Clause 2 - Normative references
- Clause 3 - Terms and definitions
- Clause 4 - Classification
- Clause 5 - Requirements
- Clause 6 - Sampling
- Clause 7 - Measurements and test methods
- Clause 8 - Packaging
- Clause 9 - Accompanying information
Clause 4 divides products into Type 1 glue type and Type 2 liner type, and Clause 4 further splits Type 1 into powder, cream, and sheet or tape classes. That structure matters because the test methods and product description depend on the type and class claimed.
What are the key requirements of SIST EN ISO 10873:2026?
SIST EN ISO 10873:2026 is built around product classification, stability, performance testing and user information. The main requirements are the ones manufacturers and laboratories need to prove before a product can be described and assessed against the standard.
Product classification drives the test route
Clause 4 classifies denture adhesives as Type 1 glue type or Type 2 liner type. Type 1 includes powder, cream, and sheet or tape classes, while Type 2 is a non-aqueous liner type.
This matters in practice because the class determines which sample preparation, test method and acceptance criterion apply. A producer must state the product category correctly before testing can begin.
General quality expectations apply to all products
Clause 5.1.1 asks for particular attention to biocompatibility, especially the release of metallic ions. Clause 5.1.3 requires the product to show no deterioration after the aging procedure in 7.2.
For users and buyers, this means the adhesive has to remain acceptable after storage and should be considered from both a performance and biological-safety viewpoint.
Type 1 adhesives must wash off and hold the denture
Clause 5.2.1 requires no residual lump on a PMMA plate after the washability test in 7.3. Clause 5.2.2 requires adhesion strength of at least 5 kPa, measured by the Type 1 adhesion tests in 7.4 and 7.5.
In practice, Type 1 products have to do two things at once - stay attached during use and still clean away without leaving visible residue on the denture surface.
Type 2 adhesives must grip, peel cleanly and have workable consistency
Clause 5.3.1 requires adhesion strength of at least 5 kPa in the Type 2 adhesion test in 7.6. Clause 5.3.2 requires no residual lump after the peeling test in 7.7. Clause 5.3.3 requires a consistency of at least 15 mm in 7.8.
This matters because Type 2 products are judged not only on holding power, but also on how cleanly they separate and how their body or spreadability behaves under load.
Sampling and test conditions are controlled
Clause 6 says the sample shall come from one lot and be sufficient for all tests in Clause 7. Clause 7.1 sets the test temperature at (23 ± 3) °C.
That gives a consistent basis for comparison between batches and between laboratories. It also means the sample has to be large enough to cover the whole test program.
Stability is checked by accelerated aging
Clause 7.2 stores the product in its original container at (40 ± 2) °C and (75 ± 5) % relative humidity for 3 months, or under equivalent conditions that simulate room-temperature storage for 30 months.
In practice, this is the document’s way of checking whether the adhesive remains fit for use over storage time without waiting for the full shelf life.
Test results are judged by a fixed pass/fail rule
Clause 7.9 says that if four or more of five test results conform, the product passes. If three or more of five do not conform, it fails. If only three of five conform, the standard allows an additional five samples for that test, and all of those must conform.
This matters for batch release and product qualification because the decision rule is stated in advance and does not depend on local interpretation.
Packaging and user information are part of conformity
Clause 8 requires packaging that does not contaminate, and does not allow contamination, of the adhesive. Clause 9 requires instructions for use and package labelling with application, removal, ingredients, cautions, safety notes, storage information, manufacturer or distributor details, trade name, product description by classification, lot number, net contents, and tracking code when the shelf life is less than 30 months.
That means conformity is not just about test results - it also depends on how the product is supplied and identified in the market.
What terms does SIST EN ISO 10873:2026 define?
SIST EN ISO 10873:2026 uses a small set of key terms that help separate product types and test materials.
- Denture adhesive - a dental product placed on the intaglio surface of a removable denture to temporarily improve retention to soft supporting tissues.
- Intaglio surface - the fitting surface of a removable denture.
- Glue type - a denture adhesive in powder, cream, sheet or tape form with a water-soluble polymer as the adhesive constituent.
- Liner type - a denture adhesive in non-aqueous form.
- Type 1 adhesive - the document’s term for glue type products, which are further divided into powder, cream, and sheet or tape classes.
- Type 2 adhesive - the document’s term for liner type products, which are tested differently from Type 1 products.
- PMMA - poly(methyl methacrylate), the plastic used for the plates and holders in the test methods.
Who uses SIST EN ISO 10873:2026?
SIST EN ISO 10873:2026 is used by denture adhesive manufacturers, contract test laboratories, quality managers, and buyers who need a technical basis for product specification and acceptance. It is also useful for packaging and regulatory teams because Clause 9 sets the required instructions and label content.
In the dental consumer products industry, the standard helps compare powder, cream, sheet/tape and liner products on a common basis. Laboratories use it to run the washability, adhesion, peeling and consistency tests under defined conditions.
What changed in SIST EN ISO 10873:2026 from the previous edition?
SIST EN ISO 10873:2026 replaces SIST EN ISO 10873:2021, and it is stated to be technically revised. The changes named in the document are:
- the requirement for pH value in 5.1.2 was deleted
- pH value measurement in 7.2 was deleted
Which standards are used with SIST EN ISO 10873:2026?
SIST EN ISO 10873:2026 refers to several standards that support its vocabulary, test materials, safety review and labelling.
- ISO 1942 - provides dental vocabulary and the source definition for denture adhesive.
- ISO 3696:1987 - specifies the grade 3 water used in the test methods.
- ISO 7823-2 - specifies the PMMA sheets used for plates and holders in the tests.
- ISO 8601-1 - gives the date representation used in the tracking code on the package.
- ISO 7405 - is recommended for assessing biocompatibility of dental medical devices.
- ISO 10993-1 - is recommended for biological evaluation within a risk management process.
- ISO 16212, ISO 18415, ISO 18416, ISO 21148, ISO 21149, ISO 21150, ISO 22717, ISO 22718, ISO 29621 - are cited as sources for microbiological contamination testing and risk assessment.
What does the SIST EN ISO 10873:2026 document contain?
SIST EN ISO 10873:2026 contains detailed laboratory procedures for washability, adhesion strength, peeling and consistency, together with the apparatus and materials needed for each method. Clause 7 also includes figures showing the test instruments, sample holders, layouts and sample preparation steps.
Table 1 ties each test method to the requirement it supports and states the pass/fail logic used in assessment. Clauses 8 and 9 provide the packaging and accompanying-information requirements that support safe use and traceability.
Relations
- Effective Date
- 01-Sep-2026
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Frequently Asked Questions
SIST EN ISO 10873:2026 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Denture adhesives (ISO 10873:2026)". 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.
SIST EN ISO 10873:2026 is classified under the following ICS (International Classification for Standards) categories: 11.060.01 - Dentistry in general; 71.100.70 - Cosmetics. Toiletries; 97.170 - Body care equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 10873:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10873:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 10873:2026 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)
SLOVENSKI STANDARD
01-september-2026
Nadomešča:
SIST EN ISO 10873:2021
Zobozdravstvo - Lepila za zobne proteze (ISO 10873:2026)
Dentistry - Denture adhesives (ISO 10873:2026)
Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2026)
Médecine bucco-dentaire - Adhésifs pour prothèses dentaires (ISO 10873:2026)
Ta slovenski standard je istoveten z: EN ISO 10873:2026
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10873
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2026
EUROPÄISCHE NORM
ICS 71.100.70 Supersedes EN ISO 10873:2021
English Version
Dentistry - Denture adhesives (ISO 10873:2026)
Médecine bucco-dentaire - Adhésifs pour prothèses Zahnheilkunde - Prothesenhaftmittel (ISO
dentaires (ISO 10873:2026) 10873:2026)
This European Standard was approved by CEN on 27 April 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10873:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10873:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2027, and conflicting national standards shall
be withdrawn at the latest by January 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10873:2021.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10873:2026 has been approved by CEN as EN ISO 10873:2026 without any modification.
International
Standard
ISO 10873
Third edition
Dentistry — Denture adhesives
2026-06
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Reference number
ISO 10873:2026(en) © ISO 2026
ISO 10873:2026(en)
© ISO 2026
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.
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
ISO 10873:2026(en)
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
ISO 10873:2026(en)
Bibliography . 14
iv
ISO 10873:2026(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 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
ISO 10873:2026(en)
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
International Standard ISO 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
c
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