SIST EN 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 punktförmige 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. Dieses System wird in dieser Norm nicht beschrieben. Für die Behauptung, das Produkt sei steril, ist der Hersteller verantwortlich. (siehe Tabelle 3). Dieses Dokument gilt nicht 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 und Verpackung einschließlich der Gebrauchsanweisung fest. Dieses Dokument legt keine Anforderungen oder Prüfverfahren für die Sterilität fest. Verweise 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

• Status: Not Published
• Public Enquiry End Date: 30-May-2024
• ICS: 11.060.10 - Dental materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Sep-2025
• Due Date: 06-Nov-2025
• Ref Project: EN ISO 6877:2025 - Dentistry - Endodontic obturating materials (ISO 6877:2025)

Relations

• Replaces: SIST EN ISO 6877:2021 - Dentistry - Endodontic obturating materials (ISO 6877:2021)
• Effective Date: 01-Oct-2025

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 6877:2024
01-maj-2024
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov
(obturacijo) (ISO/DIS 6877:2024)
Dentistry - Endodontic obturating materials (ISO/DIS 6877:2024)
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO/DIS 6877:2024)
Médecine bucco-dentaire - Matériaux d’obturation endodontique (ISO/DIS 6877:2024)
Ta slovenski standard je istoveten z: prEN ISO 6877
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 6877:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 6877:2024
oSIST prEN ISO 6877:2024
DRAFT
International
Standard
ISO/DIS 6877
ISO/TC 106/SC 1
Dentistry — Endodontic obturating
Secretariat: AFNOR
materials
Voting begins on:
Médecine bucco-dentaire — Matériaux d’obturation
2024-03-21
endodontique
Voting terminates on:
ICS: 11.060.10 2024-06-13
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 6877:2024(en)
oSIST prEN ISO 6877:2024
DRAFT
ISO/DIS 6877:2024(en)
International
Standard
ISO/DIS 6877
ISO/TC 106/SC 1
Dentistry — Endodontic obturating
Secretariat: AFNOR
materials
Voting begins on:
Médecine bucco-dentaire — Matériaux d’obturation
endodontique
Voting terminates on:
ICS: 11.060.10
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
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 6877:2024(en)
ii
oSIST prEN ISO 6877:2024
ISO/DIS 6877:2024(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 Appearance .4
4.2 Length .4
4.3 General .4
4.4 Nominal size and tolerances.4
4.5 Colour-coding .4
4.6 Taper .4
4.7 Carrier-based obturating material .7
4.8 Physical integrity .7
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
6.3 Length .8
6.3.1 Apparatus .8
6.3.2 Method . .8
6.4 Taper and nominal size measurements .8
6.4.1 Apparatus .8
6.4.2 Method for taper of standard and greater taper points .9
6.4.3 Method for initial taper of variable taper points .9
6.5 Physical integrity .9
6.5.1 General .9
6.5.2 Apparatus .9
6.5.3 Method . .10
6.5.4 Interpretation of the results .10
6.6 Radio-opacity .11
6.6.1 Apparatus .11
6.6.2 Method . .11
6.6.3 Interpretation of the results .11
6.7 Melt mass-flow rate . 12
7 Product information .12
7.1 Marking . 12
7.2 Packaging and labelling . 12
Annex A (normative) Melt mass-flow rate test .15
Bibliography . 19

iii
oSIST prEN ISO 6877:2024
ISO/DIS 6877:2024(en)
Foreword
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