oSIST prEN ISO 10873:2020
(Main)Dentistry - Denture adhesives (ISO/DIS 10873:2019)
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
RELATIONS
Standards Content (sample)
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
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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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
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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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
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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.
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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 10993-1vi © ISO 2019 – All rights reserved
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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 — VocabularyISO 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 sheetsISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and timesISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management processISO 21148, Cosmetics — Microbiology — General instructions for microbiological examination
3 Terms and definitionsFor 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 tissues3.2
glue type
denture adhesive in powder, cream, sheet or tape form with water-soluble polymer as adhesive
constituent3.3
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 adhesives5.2.1 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 adhesives5.3.1 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 methods7.1 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 Reagents7.2.2.1 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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