SIST EN ISO 6877:2025
(Main)Dentistry - Endodontic obturating materials (ISO 6877:2025)
Dentistry - Endodontic obturating materials (ISO 6877:2025)
This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2025)
Dieses Dokument legt die Anforderungen an die Abmessungen verschiedener endodontischer Obturationsmaterialien und die Röntgensichtbarkeit für Polymerstifte, polymerbeschichtete thermoplastische Obturationsträger, nicht stiftförmige thermoplastische Obturationsmaterialien oder Kombinationen der oben genannten fest, die zur Obturation eines Wurzelkanalsystems verwendet werden. Es legt außerdem ein Nummernsystem und ein Farbkennzeichnungssystem zur Größenbezeichnung der vorgeformten endodontischen Obturationsstifte, ein Verfahren zur Bestimmung der Schmelze-Massefließrate für Injektionsmaterial sowie die Anforderungen an die Kennzeichnung, Etikettierung, Verpackung und Gebrauchsanweisung fest.
Zahnärztliche endodontische Obturationsstifte sind in steriler oder nicht steriler Form im Handel erhältlich. Sterilität wird in diesem Dokument nicht beschrieben. Die Angabe, dass das Produkt steril ist, liegt in der Verantwortung des Herstellers (siehe Tabelle 3). Dieses Dokument ist nicht anwendbar für Instrumente oder Geräte zur Verwendung mit Obturationsmaterialien, die durch Hitze plastisch werden, oder für Materialien, die eine Kronenrestauration unterstützen.
Abschnitt 7 legt die Anforderungen an die Kennzeichnung, Etikettierung und Verpackung einschließlich der Gebrauchsanweisung fest. Dieses Dokument legt keine Anforderungen oder Prüfverfahren für die Sterilität fest. Verweisungen auf geltende nationale Vorschriften, international anerkannte Arzneibücher und Normen zur Validierung von Sterilisationsprozessen können gelten.
Médecine bucco-dentaire - Matériaux d’obturation endodontique (ISO 6877:2025)
Le présent document spécifie les exigences pour les dimensions de divers matériaux d’obturation endodontique et pour la radiopacité des cônes polymères, des matériaux d’obturation thermoplastiques revêtus de polymère, des matériaux d’obturation thermoplastiques qui ne sont pas en forme de cônes ou les combinaisons de ceux-ci, qui sont utilisés dans le cadre de l’obturation d’un système de canaux radiculaires. Il spécifie également des systèmes numériques et un système de code de couleur pour la désignation des tailles de cônes d’obturation endodontique préformés, une méthode de détermination de l’indice de fluidité à chaud en masse pour le matériau d'injection ainsi que les exigences relatives au marquage, à l’étiquetage, à l’emballage et aux instructions d’utilisation.
Les cônes d'obturation endodontique sont commercialisés stérilisés ou non stérilisés. La stérilité n’est pas abordée dans le présent document et toute revendication indiquant que le produit est stérile n’engage que le fabricant (voir Tableau 3). Le présent document ne s’applique pas aux instruments ou à l’appareillage utilisés avec des matériaux d’obturation qui se plastifient sous l’effet de la chaleur ou des matériaux utilisés pour l’ancrage d’une restauration coronaire.
L’Article 7 spécifie le marquage, l’étiquetage et l’emballage, y compris les instructions d’utilisation. Le présent document ne spécifie aucune exigence ou méthode d’essai relative à la stérilité. Toute référence aux réglementations nationales en vigueur, à la pharmacopée reconnue au niveau mondial et aux normes sur la validation des procédés de stérilisation peut s’appliquer.
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov (obturacijo) (ISO 6877:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Nadomešča:
SIST EN ISO 6877:2021
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov
(obturacijo) (ISO 6877:2025)
Dentistry - Endodontic obturating materials (ISO 6877:2025)
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2025)
Médecine bucco-dentaire - Matériaux d’obturation endodontique (ISO 6877:2025)
Ta slovenski standard je istoveten z: EN ISO 6877:2025
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 6877
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 6877:2021
English Version
Dentistry - Endodontic obturating materials (ISO
6877:2025)
Médecine bucco-dentaire - Matériaux d'obturation Zahnheilkunde - Endodontische Obturationswerkstoffe
endodontique (ISO 6877:2025) (ISO 6877:2025)
This European Standard was approved by CEN on 25 May 2025.
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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6877:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 6877:2025) 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 February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
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 6877:2021.
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 website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 6877:2025 has been approved by CEN as EN ISO 6877:2025 without any modification.
International
Standard
ISO 6877
Fourth edition
Dentistry — Endodontic obturating
2025-08
materials
Médecine bucco-dentaire — Matériaux d’obturation
endodontique
Reference number
ISO 6877:2025(en) © ISO 2025
ISO 6877:2025(en)
© ISO 2025
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
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Published in Switzerland
ii
ISO 6877:2025(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 Appearance .3
4.2 Length .3
4.3 Designation and nominal size .4
4.4 Tolerances .4
4.5 Colour-coding .4
4.6 Taper .4
4.7 Carrier-based obturating device .7
4.8 Physical integrity .8
4.9 Radiopacity .8
5 Procurement of samples . 8
6 Measurement and test methods . 8
6.1 Test conditions .8
6.2 Visual examination .8
6.2.1 General .8
6.2.2 Interpretation of the results .9
6.3 Length .9
6.3.1 Apparatus .9
6.3.2 Method . .9
6.3.3 Interpretation of the results .9
6.4 Taper measurements .9
6.4.1 Apparatus .9
6.4.2 Method for taper of standard and greater taper points .9
6.4.3 Interpretation of the results .10
6.5 Physical integrity .10
6.5.1 General .10
6.5.2 Apparatus .10
6.5.3 Method . .10
6.5.4 Interpretation of the results .10
6.6 Radiopacity .11
6.6.1 General .11
6.6.2 Apparatus .11
6.6.3 Method . . 12
6.6.4 Interpretation of the results . 12
6.7 Melt mass-flow rate . 12
7 Product information .12
7.1 Labelling . 12
7.2 Marking . 1
...
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