SIST EN ISO 10873:2021
(Main)Dentistry - Denture adhesives (ISO 10873:2021)
Dentistry - Denture adhesives (ISO 10873:2021)
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.
Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2021)
Dieses Dokument klassifiziert Prothesenhaftmittel, die von Prothesenträgern verwendet werden; es legt auch Anforderungen, Prüfverfahren und die Gebrauchsanweisung, die mit diesen Produkten ausgeliefert wird, fest.
Dieses Dokument ist anzuwenden für Prothesenhaftmittel, die vom Verbraucher angewendet werden, und schließt dentale Unterfütterungsmaterialien, die durch den Zahnarzt verordnet oder angewendet werden, aus.
Médecine bucco-dentaire - Adhésifs pour prothèses dentaires (ISO 10873:2021)
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.
Zobozdravstvo - Lepila za zobne proteze (ISO 10873:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10873:2021
01-september-2021
Nadomešča:
SIST EN ISO 10873:2010
Zobozdravstvo - Lepila za zobne proteze (ISO 10873:2021)
Dentistry - Denture adhesives (ISO 10873:2021)
Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2021)
Médecine bucco-dentaire - Adhésifs pour prothèses dentaires (ISO 10873:2021)
Ta slovenski standard je istoveten z: EN ISO 10873:2021
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST EN ISO 10873:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10873:2021
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SIST EN ISO 10873:2021
EN ISO 10873
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 10873:2010
English Version
Dentistry - Denture adhesives (ISO 10873:2021)
Médecine bucco-dentaire - Adhésifs pour prothèses Zahnheilkunde - Prothesenhaftmittel (ISO
dentaires (ISO 10873:2021) 10873:2021)
This European Standard was approved by CEN on 6 May 2021.
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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10873:2021 E
worldwide for CEN national Members.
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SIST EN ISO 10873:2021
EN ISO 10873:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10873:2021
EN ISO 10873:2021 (E)
European foreword
This document (EN ISO 10873:2021) 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 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
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 10873:2010.
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 websites.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10873:2021 has been approved by CEN as EN ISO 10873:2021 without any modification.
3
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SIST EN ISO 10873:2021
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SIST EN ISO 10873:2021
INTERNATIONAL ISO
STANDARD 10873
Second edition
2021-07
Dentistry — Denture adhesives
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Reference number
ISO 10873:2021(E)
©
ISO 2021
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
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 pH value . 2
5.1.3 Microbiology . 2
5.1.4 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 . 3
5.3.1 Adhesion strength . . 3
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 pH value measurement . 3
7.2.1 Apparatus and material . 3
7.2.2 Reagents . 3
7.2.3 Procedure . 4
7.3 Determination of stability — Aging procedure . 4
7.4 Test of washability (for Type 1 adhesives) . 4
7.4.1 Apparatus and materials . 4
7.4.2 Reagent . . 5
7.4.3 Procedure . 5
7.5 Adhesion strength test I (for Type 1 adhesives) . 5
7.5.1 General. 5
7.5.2 Apparatus . 5
7.5.3 Procedure . 7
7.6 Adhesion strength test II (for Type 1 adhesives) . 9
7.6.1 General. 9
7.6.2 Apparatus . 9
7.6.3 Procedure . 9
7.7 Adhesion strength test (for Type 2 adhesives) .10
7.7.1 Apparatus .10
7.7.2 Procedure .12
7.8 Peeling test (for Type 2 adhesives) .12
7.8.1 Apparatus and materials .12
7.8.2 Reagent . .13
7.8.3 Procedure .13
7.9 Consistency test (for Type 2 adhesives).13
7.9.1 Apparatus .13
7.9.2 Procedure .15
7.10 Assessment .15
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
8 Packaging .16
9 Accompanying information .16
9.1 Information to be included in the instructions for use .16
9.2 Labelling on the package .17
Bibliography .18
iv © ISO 2021 – All rights reserved
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
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 second edition cancels and replaces the first edition (ISO 10873:2010), which has been technically
revised. The main changes compared to the previous edition are as follows:
— the powder/water ratio described in 7.5.3.1 and 7.6.3.1 has been revised;
— the method for pH value measurement has been modified in part;
— the surface roughness of the sample holder has been revised.
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.
© ISO 2021 – All rights reserved v
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
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.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 10873:2021
INTERNATIONAL STANDARD ISO 10873:2021(E)
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// 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
© ISO 2021 – All rights reserved 1
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
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 pH value
Denture adhesives shall have a pH value within the range of 4 to 10 when tested in accordance with 7.2
or another validated method.
5.1.3 Microbiology
Testing for microbiological contamination shall be carried out according to appropriate methods such
as those listed in References [3] to [15].
5.1.4 Stability
The denture adhesive shall show no signs of deterioration which may affect compliance with this
document after being subjected to one of the aging procedures specified in 7.3.
5.2 Specific requirements for Type 1 adhesives
5.2.1 Washability
There shall be no residual lump when tested in accordance with 7.4.
5.2.2 Strength of the adhesion to the prosthesis
Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.5 and 7.6.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
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 7.7.
5.3.2 Peeling property
There shall be no residual lump when tested in accordance with 7.8.
5.3.3 Consistency
Consistency shall not be less than 15 mm when tested in accordance with 7.9.
6 Sampling
The sample shall be taken from one lot and shall be sufficient to complete all tests specified in Clause 7.
7 Measurements and test methods
7.1 Test conditions
All test shall be conducted at a temperature of (23 ± 3) °C.
7.2 pH value measurement
7.2.1 Apparatus and material
7.2.1.1 pH meter
7.2.1.1.1 pH meter, with a glass and comparison electrode assembly with an accuracy of ±0,02.
7.2.1.1.2 pH meter, with a flat type pH compound electrode.
7.2.1.2 Container
7.2.1.2.1 Glass container, of 500 ml capacity.
7.2.1.2.2 Container, of 35 mm in diameter and 10 mm in height.
7.2.1.3 Circular filter paper, of 40 mm in radius.
7.2.2 Reagents
7.2.2.1 Propylene glycol, analytical grade.
7.2.2.2 Water, shall be of grade 3 in accordance with ISO 3696:1987.
7.2.2.3 Sodium chloride, analytical grade.
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
7.2.3 Procedure
7.2.3.1 Type 1 adhesives
7.2.3.1.1 Class 1
Take (1,0 ± 0,1) g of a Class 1 denture adhesive in the container (7.2.1.2.1), add 5 g of propylene glycol
(7.2.2.1) to disperse it, and while stirring, add 300 ml of water (7.2.2.2) and mix them sufficiently. Insert
the electrode of the pH meter (7.2.1.1.1) into the dispersion and take the pH meter reading 3 min after
the insertion.
7.2.3.1.2 Class 2
7.2.3.1.2.1 Procedure using pH meter with a flat type compound electrode
Take (1,0 ± 0,1) g of a Class 2 denture adhesive in the container (7.2.1.2.2) and spread evenly, then pour
5,0 ml of 0,9 g/dl sodium chloride (7.2.2.3) solution onto the sample. Cover the container (7.2.1.2.2),
then keep it for 10 min. Insert the flat type pH compound electrode of the pH meter (7.2.1.1.2) into the
0,9 g/dl sodium chloride (7.2.2.3) solution and monitor the pH until a steady pH is determined.
NOTE This procedure is suitable for Class 2 denture adhesives which do not have internal diffusion capacity
against aqueous solutions.
7.2.3.1.2.2 Alternative procedure using pH meter with a glass and reference electrode
Take (1,0 ± 0,1) g of a Class 2 denture adhesive in the container (7.2.1.2.1), add 5 g of propylene glycol
(7.2.2.1) to disperse it, and while stirring, add 300 ml of water (7.2.2.2) and mix them sufficiently. Insert
the electrode of the pH meter (7.2.1.1.1) into the dispersion and take the pH meter reading 3 min after
the insertion.
NOTE This procedure is suitable for various type of Class 2 denture adhesives.
7.2.3.1.3 Class 3
Take (1,0 ± 0,1) g of a Class 3 denture adhesive in the container (7.2.1.2.1), add 300 ml of water and mix
them sufficiently. Insert the electrode of the pH meter and take the pH meter reading 3 min after the
insertion.
7.2.3.2 Type 2 adhesives
Take (1,0 ± 0,1) g of denture adhesive, and spread evenly over a radius of approximately 40 mm on a
piece of filter paper (7.2.1.3). Place the filter paper in the container (7.2.1.2.1) and add 300 ml of water
to it. After immersing in water for 1 h, insert the electrode of the pH meter into water and take the pH
meter reading 3 min after the insertion.
7.3 Determination of stability — Aging procedure
Store the denture adhesives in their original containers at (40 ± 2) °C at (75 ± 5) % relative humidity for
3 months or at such conditions of time and temperature as will simulate storage at room temperature
[16]
for 30 months .
7.4 Test of washability (for Type 1 adhesives)
7.4.1 Apparatus and materials
7.4.1.1 Water bath, capable of being maintained at a temperature of (37 ± 2) °C.
4 © ISO 2021 – All rights reserved
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SIST EN ISO 10873:2021
ISO 10873:2021(E)
7.4.1.2 Poly(methyl methacrylate) (PMMA) plate, approximately 50 mm × 50 mm, shall be in
accordance with ISO 7823-2.
7.4.2 Reagent
Water, in accordance with 7.2.2.2.
7.4.3 Procedure
Apply the denture adhesive on the PMMA plate (7.4.1.2) evenly following the manufacturer's
instructions for use and immerse the plate in water for 1 h in the water bath (7.4.1.1) maintained at
(37 ± 2) °C.
Wash the PMMA plate following the manufacturer's instructions for use and inspect the PMMA plate
surface with the naked eye, without magnification. Repeat the tests to obtain five test results.
7.5 Adhesion strength test I (for Type 1 adhesives)
7.5.1 General
Conduct the following adhesion strength test within 3 min after removal from the water bath.
7.5.2 Apparatus
7.5.2.1 Adhesion test instrument, having a sample stand, of capacity up to 10 N (for both frame and
load cell), with a cross-head speed up to 5 mm/min. See Figure 1.
7.5.2.2 Sample holder I, having a hole with a diameter of (22 ± 1) mm, depth of (0,5 ± 0,1) mm and a
surface roughness of 2,0 μm and below, made of poly(methyl methacrylate) complying with ISO 7823-2.
See Figure 2 a).
After testing, detergent solution is recommended to remove the denture adhesive left on the sample
holder surface.
7.5.2.3 Sample holder II, having a raised circular part with a diameter of (22 ± 1) mm, a height of
(5,0 ± 0,1) mm and a surface roughness of 2,0 μm and below, made of poly(methyl methacrylate)
complying with ISO 7823-2. See Figure 2 b).
After testing, detergent solution is recommended to remove the denture adhesive left on the sample
holder surface.
7.5.2.4 Pressure sensitive shaft, having a circular base with a diameter of (20,0 ± 0,5) mm, made of
poly(methyl methacrylate) complying with ISO 7823-2. See Figure 3.
© ISO 2021 – All rights reserved 5
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...
SLOVENSKI STANDARD
oSIST prEN ISO 10873:2020
01-februar-2020
Zobozdravstvo - Lepila za zobne proteze (ISO/DIS 10873:2019)
Dentistry - Denture adhesives (ISO/DIS 10873:2019)
Zahnheilkunde - Prothesenhaftmittel (ISO/DIS 10873:2019)
Médecine bucco-dentaire - Adhésifs pour prothèses dentaires (ISO/DIS 10873:2019)
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 10873:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10873:2020
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oSIST prEN ISO 10873:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10873
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:
2019-11-28 2020-02-20
Dentistry — Denture adhesives
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
ICS: 97.170
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10873:2019(E)
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. ISO 2019
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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General . 2
5.1.1 Biocompatibility . 2
5.1.2 pH value . 2
5.1.3 Microbiology . 2
5.1.4 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 Test methods . 3
7.1 Test conditions . 3
7.2 pH value measurement . 3
7.2.1 Apparatus and material . 3
7.2.2 Reagents . 3
7.2.3 Procedure . 4
7.3 Determination of stability — Aging procedure . 4
7.4 Test of washability (for Type 1 adhesives) . 4
7.4.1 Apparatus and materials . 4
7.4.2 Reagent . . 5
7.4.3 Procedure . 5
7.5 Adhesion strength test I (for Type 1 adhesives) . 5
7.5.1 General. 5
7.5.2 Apparatus . 5
7.5.3 Procedure . 7
7.6 Adhesion strength test II (for Type 1 adhesives) . 9
7.6.1 General. 9
7.6.2 Apparatus (see 7.5.2) . 9
7.6.3 Procedure . 9
7.7 Adhesion strength test (for Type 2 adhesives) .10
7.7.1 Apparatus .10
7.7.2 Procedure .11
7.8 Peeling test (for Type 2 adhesives) .11
7.8.1 Apparatus and materials .11
7.8.2 Reagents .12
7.8.3 Procedure .12
7.9 Consistency test (for Type 2 adhesives).12
7.9.1 Apparatus .12
7.9.2 Procedure .13
7.10 Assessment .14
8 Packaging .14
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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(E)
9 Accompanying information .14
9.1 Information to be included in the instructions for use .14
9.2 Labelling on the package .15
Bibliography .16
iv © ISO 2019 – All rights reserved
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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(E)
Foreword
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electrotechnical standardization.
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The committee responsible for this document is Technical Committee ISO/TC 106, Dentistry,
Subcommittee SC 7, Oral care products.
This second edition cancels and replaces the first edition (ISO 10873:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— a powder/water ratio described in 7.5.4.1 and 7.6.4.1 has been revised.
— method of pH value measurement has been modified in part.
— surface roughness of the sample holder has been revised.
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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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DRAFT INTERNATIONAL STANDARD ISO/DIS 10873:2019(E)
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 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 21148, Cosmetics — Microbiology — General instructions for microbiological examination
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
denture adhesives
dental product placed on the intaglio surface (fitting surface) of a removable denture to temporarily
improve its retention to soft supporting tissues
3.2
glue type
denture adhesive in powder, cream, sheet or tape form with water-soluble polymer as adhesive
constituent
3.3
liner type
denture adhesive in non-aqueous form
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4 Classification
For the purposes of this International Standard, denture adhesives are categorized as one of the
following types:
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 pH value
Denture adhesives shall have a pH value within the range of 4 to 10 when tested in accordance with 7.2
or another validated method.
5.1.3 Microbiology
Testing for microbiological contamination shall be carried out according to appropriate methods such
as those listed in Bibliography [1] to [12].
5.1.4 Stability
The denture adhesive shall show no signs of deterioration which may affect compliance with this
International Standard after being subjected to one of the aging procedures specified in 7.3.
5.2 Specific requirements for Type 1 adhesives
5.2.1 Washability
There shall be no residual lump when tested in accordance with 7.4.
5.2.2 Strength of the adhesion to the prosthesis
Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.5 and 7.6.
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 7.7.
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5.3.2 Peeling property
There shall be no residual lump when tested in accordance with 7.8.
5.3.3 Consistency
Consistency shall not be less than 15 mm when tested in accordance with 7.9.
6 Sampling
The sample shall be taken from one lot and shall be sufficient to complete all tests specified in Clause 7.
7 Test methods
7.1 Test conditions
All test shall be conducted at a temperature of (23 ± 3)°C .
7.2 pH value measurement
7.2.1 Apparatus and material
7.2.1.1 pH meter
7.2.1.1.1 pH meter, with a glass and comparison electrode assembly with an accuracy of ±0,02.
7.2.1.1.2 pH meter, with a flat type pH compound electrode.
7.2.1.2 Container
7.2.1.2.1 Glass container, of 500 ml capacity.
7.2.1.2.2 Container, of 35 X 10 mm.
7.2.1.3 Circular filter paper, used to separate fine precipitates for chemical analysis.
7.2.2 Reagents
7.2.2.1 Propylene glycol, analytical grade.
7.2.2.2 Water, grade 3 in accordance with ISO 3696; 1987.
7.2.2.3 Sodium chloride, analytical grad
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7.2.3 Procedure
7.2.3.1 Type 1 adhesives
7.2.3.1.1 Class 1
Take (1,0 ± 0,1) g of a Class 1 denture
...
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