FprEN ISO 10873

SLOVENSKI STANDARD
oSIST prEN ISO 10873:2025
01-maj-2025
Zobozdravstvo - Lepila za zobne proteze (ISO/DIS 10873:2025)
Dentistry - Denture adhesives (ISO/DIS 10873:2025)
Zahnheilkunde - Prothesenhaftmittel (ISO/DIS 10873:2025)
Médecine bucco-dentaire - Adhésifs pour prothèses dentaires (ISO/DIS 10873:2025)
Ta slovenski standard je istoveten z: prEN ISO 10873
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST prEN ISO 10873:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 10873:2025
oSIST prEN ISO 10873:2025
DRAFT
International
Standard
ISO/DIS 10873
ISO/TC 106/SC 7
Dentistry — Denture adhesives
Secretariat: JISC
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Voting begins on:
2025-03-05
ICS: 71.100.70
Voting terminates on:
2025-05-28
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 10873:2025(en)
oSIST prEN ISO 10873:2025
DRAFT
ISO/DIS 10873:2025(en)
International
Standard
ISO/DIS 10873
ISO/TC 106/SC 7
Dentistry — Denture adhesives
Secretariat: JISC
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Voting begins on:
ICS: 71.100.70
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10873:2025(en)
ii
oSIST prEN ISO 10873:2025
ISO/DIS 10873:2025(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 .2
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 .3
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 A ssessment . 12
8 Packaging.13
9 Accompanying information .13
9.1 Information to be included in the instructions for use . 13
9.2 Labelling on the package . 13

iii
oSIST prEN ISO 10873:2025
ISO/DIS 10873:2025(en)
Bibliography . 14

iv
oSIST prEN ISO 10873:2025
ISO/DIS 10873:2025(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 compared to the previous edition are as follows:
— the requirement for pH value (5.1.2) has been deleted, and
— 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.

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oSIST prEN ISO 10873:2025
ISO/DIS 10873:2025(en)
Introduction
Denture adhesives are used for the improvement in retention stability of removable denture 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.
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oSIST prEN ISO 10873:2025
DRAFT International Standard ISO/DIS 10873:2025(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

oSIST prEN ISO 10873:2025
ISO/DIS 10873:2025(en)
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
Testing for microbiological contamination shall be carried out according to appropriate methods such as
those listed in References [3] to [15].
5.1.3 Stability
The denture adhesive shall show no signs of deterioration which may affect compliance with this document
after being subjected to one of the ag
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