kSIST FprEN ISO 6876:2025
(Main)Dentistry - Endodontic sealing material (ISO/FDIS 6876:2025)
Dentistry - Endodontic sealing material (ISO/FDIS 6876:2025)
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
Zahnheilkunde - Endodontische Versiegelungswerkstoffe (ISO/FDIS 6876:2025)
Dieses Dokument legt die Klassifizierung, Anforderungen und Prüfverfahren fest für endodontische Versiegelungswerkstoffe, die in der Zahnheilkunde verwendet werden.
Dieses Dokument gilt sowohl für Werkstoffe, die für die konventionelle orthograde endodontische Versiegelung (Typ 1) verwendet werden, als auch für Werkstoffe, die für andere endodontische Versiegelungsverfahren wie Apexifikation, Perforationsfüllung, Resorptionsbehandlung oder retrograde Wurzelendfüllung (Typ 2) verwendet werden.
Die endodontischen Versiegelungswerkstoffe vom Typ 2 dürfen für die Vitalpulpatherapie verwendet werden. Dieses Dokument enthält jedoch keine Anforderungen in Bezug auf die Vitalpulpatherapie.
Dieses Dokument legt keine Anforderungen oder Prüfverfahren für die Sterilität fest.
ANMERKUNG 1 Es kann auf geltende nationale Vorschriften und international anerkannte Arzneibücher verwiesen werden.
ANMERKUNG 2 Nationale Anforderungen an Sterilisationsverfahren können, falls vorhanden, angewendet werden. Es sind außerdem Normen zu Validierungsverfahren für Sterilisationsverfahren verfügbar: ISO 11737 1, ISO 11737 2 und ISO 11737 3.
Médecine bucco-dentaire - Matériaux de scellement endodontique (ISO/FDIS 6876:2025)
Le présent document spécifie la classification, les exigences et les méthodes d’essai relatives aux matériaux de scellement endodontique utilisés en médecine bucco-dentaire.
Le présent document est applicable aux matériaux utilisés pour le scellement endodontique orthograde conventionnel (type 1) et aux matériaux utilisés pour d’autres procédures de scellement endodontique, comme l’apexification, l’obturation des perforations, le traitement de résorptions ou l’obturation rétrograde des extrémités du canal radiculaire (type 2).
Les matériaux de scellement endodontique de type 2 peuvent être utilisés pour la thérapie pulpaire. Cependant, le présent document ne traite pas de la thérapie pulpaire et n’inclut pas d’exigences à ce sujet.
Le présent document ne spécifie pas d’exigences ou de méthodes d’essai applicables à la stérilité.
NOTE 1 Il est possible de se référer aux réglementations nationales en vigueur et aux pharmacopées internationalement reconnues.
NOTE 2 Il est possible d’utiliser les exigences nationales concernant les procédés de stérilisation, si elles sont disponibles. Des normes sur les méthodes de validation des procédés de stérilisation sont également disponibles: ISO 11737-1, ISO 11737-2 et ISO 11737-3.
Zobozdravstvo - Endodontski zapiralni materiali (ISO/FDIS 6876:2025)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 6876:2025
01-januar-2025
Zobozdravstvo - Endodontski zapiralni materiali (ISO/DIS 6876:2024)
Dentistry - Endodontic sealing material (ISO/DIS 6876:2024)
Zahnheilkunde - Endodontische Versiegelungswerkstoffe (ISO/DIS 6876:2024)
Médecine bucco-dentaire - Matériaux de scellement endodontique (ISO/DIS 6876:2024)
Ta slovenski standard je istoveten z: prEN ISO 6876
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 6876:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 6876:2025
oSIST prEN ISO 6876:2025
DRAFT
International
Standard
ISO/DIS 6876
ISO/TC 106/SC 1
Dentistry — Endodontic sealing
Secretariat: AFNOR
materials
Voting begins on:
ICS: 11.060.10
2024-11-20
Voting terminates on:
2025-02-12
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 6876:2024(en)
oSIST prEN ISO 6876:2025
DRAFT
ISO/DIS 6876:2024(en)
International
Standard
ISO/DIS 6876
ISO/TC 106/SC 1
Dentistry — Endodontic sealing
Secretariat: AFNOR
materials
Voting begins on:
ICS: 11.060.10
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 6876:2024(en)
ii
oSIST prEN ISO 6876:2025
ISO/DIS 6876:2024(en)
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
5.2 Appearance .3
5.3 Flow (Type 1 only) .3
5.4 Working time (Type 1 only) .3
5.5 Setting time .3
5.6 Film thickness (Type 1 only) . .3
5.7 Solubility and disintegration .3
5.8 Radio-opacity .3
6 Sampling . 4
7 Test methods . 4
7.1 Test conditions .4
7.2 Appearance .4
7.2.1 General .4
7.2.2 Treatment of results .4
7.3 Flow (Type 1 materials) .4
7.3.1 General .4
7.3.2 Apparatus .4
7.3.3 Procedure .5
7.3.4 Treatment of results .6
7.4 Working time (Type 1 only) .6
7.4.1 General .6
7.4.2 Apparatus .6
7.4.3 Procedure .6
7.4.4 Treatment of results .7
7.5 Setting time .7
7.5.1 General .7
7.5.2 Apparatus .7
7.5.3 Preconditioning of the apparatus .8
7.5.4 Sample preparation .8
7.5.5 Procedure .8
7.6 Film thickness (Type 1 root canal sealing materials only) .9
7.6.1 Apparatus .9
7.6.2 Procedure .9
7.6.3 Treatment of results .9
7.7 Solubility and disintegration .10
7.7.1 General .10
7.7.2 Apparatus .10
7.7.3 Sample preparation .10
7.7.4 Procedure .11
7.7.5 Repetition test . 12
7.7.6 Treatment of results . 12
7.8 Radio-opacity . . 13
7.8.1 General . 13
7.8.2 Apparatus . 13
7.8.3 Preparation of test specimens . 13
iii
oSIST prEN ISO 6876:2025
ISO/DIS 6876:2024(en)
7.8.4 Treatment of results .14
8 Marking, packaging, and labelling .
...
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