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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 10873:2021(E)
© 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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ii © ISO 2021 – All rights reserved
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 .
...
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