ISO/FDIS 10873

Dentistry -- Denture adhesives

Médecine bucco-dentaire -- Adhésifs pour prothèses dentaires

General Information

• Status: Published
• ICS: 97.170 - Body care equipment
• Technical Committee: ISO/TC 106/SC 7 - Oral care products
• Drafting Committee: ISO/TC 106/SC 7/WG 9 - Dentures adhesives
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 08-Feb-2021
• Completion Date: 08-Feb-2021

RELATIONS

• Revised: ISO 10873:2010 - Dentistry -- Denture adhesives
• Effective Date: 10-Dec-2016

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10873
ISO/TC 106/SC 7
Dentistry — Denture adhesives
Secretariat: JISC
Voting begins on: Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
2021­02­08
Voting terminates on:
2021­04­05
ISO/CEN PARALLEL PROCESSING
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 10873:2021(E)
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. ISO 2021
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ISO/FDIS 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

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Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO/FDIS 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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ISO/FDIS 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

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ISO/FDIS 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 non­governmental, 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.
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ISO/FDIS 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.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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. It is recommended that, in assessing possible

biological hazards, reference be made to ISO 7405 and ISO 10993­1.
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 7823­2, Plastics — Poly(methyl methacrylate) sheets — Types, dimensions and characteristics —

Part 2: Extruded sheets

ISO 8601­1, 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
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ISO/FDIS 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.

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ISO/FDIS 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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ISO/FDIS 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 sod
...