Dentistry - Denture adhesives (ISO/DIS 10873:2019)

Zahnheilkunde - Prothesenhaftmittel (ISO/DIS 10873:2019)

Dieses Dokument klassifiziert Prothesenhaftmittel, die von Prothesenträgern verwendet werden; es beschreibt auch Anforderungen, Prüfverfahren und die Gebrauchsanweisung, die mit diesen Produkten ausgeliefert wird.
Dieses Dokument gilt für Prothesenhaftmittel, die vom Verbraucher angewendet werden, und schließt dentale Unterfütterungsmaterialien, die durch den Zahnarzt verordnet oder angewendet werden, aus. Es wird empfohlen, dass zur Bewertung von möglichen biologischen Gefährdungen auf ISO 7405 und ISO 10993-1 verwiesen wird.

Médecine bucco-dentaire - Adhésifs pour prothèses dentaires (ISO/DIS 10873:2019)

Zobozdravstvo - Lepila za zobne proteze (ISO/DIS 10873:2019)

General Information

Status
Not Published
Public Enquiry End Date
14-Feb-2020
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
23-Dec-2019
Due Date
11-May-2020
Completion Date
24-Feb-2020

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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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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

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 on 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 the following URL: www .iso .org/iso/foreword .html.

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.
© ISO 2019 – All rights reserved v
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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(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 2019 – All rights reserved
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oSIST prEN ISO 10873:2020
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.

2 © ISO 2019 – All rights reserved
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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(E)
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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oSIST prEN ISO 10873:2020
ISO/DIS 10873:2019(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
...

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