EN ISO 6877:2021

Dentistry - Endodontic obturating materials (ISO 6877:2021)

This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points.
Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied.
Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use.
This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2021)

Dieses Dokument legt die Anforderungen an die Maße verschiedener endodontischer Obturationswerkstoffe fest, einschließlich vorgeformte Metall-, vorgeformte kunststoffbeschichtete Metall-, Kunststoffstifte, thermoplastische Obturationswerkstoffe oder Kombinationen davon, die zur Obturation eines Wurzelkanalsystems geeignet sind. Dieses Dokument legt auch ein Nummernsystem und ein Farbkennzeichnungssystem zur Größenbezeichnung von vorgeformten endodontischen Obturationsstifen fest.
Zahnärztliche endodontische Obturationsstifte sind in steriler oder nicht steriler Form im Handel erhältlich. Dieses Dokument beschreibt die physikalischen Eigenschaften, die von Produkten dieser Art im Lieferzustand erwartet werden.
Anforderungen an die Sterilität sind nicht enthalten, und jeder Anspruch auf Sterilität des Produktes fällt in den Verantwortungsbereich des Herstellers (siehe Tabelle 3). Abschnitt 7 legt die Anforderungen an die Kennzeichnung einschließlich der Gebrauchsanweisung fest.
Dieses Dokument gilt nicht für Instrumente oder Ausrüstung, die zusammen mit thermoplastischen Obturationswerkstoffen (Obturationswerkstoff, der sich bei Hitze verformt), verwendet werden. Dieses Dokument gilt nicht für Werkstoffe, die für koronale Aufbauten verwendet werden.

Médecine bucco-dentaire - Matériaux d’obturation endodontique(ISO 6877:2021)

Le présent document établit les spécifications pour les dimensions de divers matériaux d’obturation endodontique incluant les cônes métalliques préformés, les cônes métalliques préformés revêtus de polymère, les cônes à base de polymères, les matériaux d’obturation thermoplastiques ou les combinaisons de ceux-ci, qui sont appropriés pour être utilisés dans le cadre de l’obturation du système de canaux radiculaires. Le présent document spécifie également des systèmes numériques et un système de code de couleur pour la désignation des tailles de cônes d’obturation endodontique préformés.
Les cônes d'obturation endodontique sont commercialisés stérilisés ou non stérilisés. Le présent document couvre les caractéristiques physiques attendues de ces produits tels qu'ils sont fournis.
La stérilité n’est pas abordée dans le présent document et toute revendication indiquant que le produit est stérile est sous la responsabilité du fabricant (voir Tableau 3). L’Article 7 spécifie l’étiquetage, y compris les instructions d’utilisation.
Le présent document ne s’applique pas aux instruments ou à l’appareillage utilisés en association avec les matériaux d'obturation thermoplastiques (matériaux d’obturation qui se déforment sous l’effet de la chaleur). Le présent document n’est pas applicable aux matériaux utilisés pour l’ancrage d’une restauration coronaire.

Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov (obturacijo) (ISO 6877:2021)

General Information

• Status: Published
• Publication Date: 21-Sep-2021
• Withdrawal Date: 30-Mar-2022
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 22-Sep-2021
• Completion Date: 22-Sep-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 6877:2021 - Dentistry - Endodontic obturating materials (ISO 6877:2021)

Relations

• Replaces: EN ISO 6877:2006 - Dentistry - Root-canal obturating points (ISO 6877:2006)
• Effective Date: 08-Jun-2022
• Revised: prEN ISO 6877 - Dentistry - Endodontic obturating materials (ISO/DIS 6877:2024)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2021
Nadomešča:
SIST EN ISO 6877:2006
Zobozdravstvo - Endodontski materiali za polnitev koreninskih kanalov
(obturacijo) (ISO 6877:2021)
Dentistry - Endodontic obturating materials (ISO 6877:2021)
Zahnheilkunde - Endodontische Obturationswerkstoffe (ISO 6877:2021)
Médecine bucco-dentaire - Matériaux d’obturation endodontique(ISO 6877:2021)
Ta slovenski standard je istoveten z: EN ISO 6877:2021
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
September 2021
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 6877:2006
English Version
Dentistry - Endodontic obturating materials (ISO
6877:2021)
Médecine bucco-dentaire - Matériaux d'obturation Zahnheilkunde - Endodontische Obturationswerkstoffe
endodontique(ISO 6877:2021) (ISO 6877:2021)
This European Standard was approved by CEN on 7 August 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 6877:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 6877:2021) 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 March 2022, and conflicting national standards shall
be withdrawn at the latest by March 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 6877:2006.
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 6877:2021 has been approved by CEN as EN ISO 6877:2021 without any modification.

INTERNATIONAL ISO
STANDARD 6877
Third edition
2021-09
Dentistry — Endodontic obturating
materials
Médecine bucco-dentaire — Matériaux d’obturation endodontique
Reference number
ISO 6877:2021(E)
©
ISO 2021
ISO 6877:2021(E)
© ISO 2021
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
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 6877:2021(E)
Contents Page
Foreword .iv
Introduction .v
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 Size designation and taper . 3
4.3.1 General. 3
4.3.2 Standard points . 3
4.3.3 Greater taper points . 5
4.3.4 Variable taper points . 5
4.3.5 Auxiliary points . 5
4.3.6 Carrier-based obturating material . 5
4.4 Physical integrity . 6
4.5 Radiopacity . 6
4.6 Colour-coding . 6
5 Procurement of samples. 7
6 Measurement and test methods . 7
6.1 Test conditions . 7
6.2 Visual examination . 7
6.2.1 General. 7
6.2.2 Labels . 7
6.2.3 Instructions for use. 8
6.3 Length . 8
6.3.1 Apparatus . 8
6.3.2 Method . 8
6.4 Size designation . 8
6.4.1 Apparatus . 8
6.4.2 Method . 8
6.4.3 Taper. 9
6.5 Physical integrity . 9
6.5.1 General. 9
6.5.2 Apparatus . 9
6.5.3 Method . 9
6.5.4 Interpretation of the results .10
6.6 Radiopacity for polymeric points and carrier-based obturating devices .11
6.6.1 Apparatus .11
6.6.2 Procedure .11
6.6.3 Interpretation of the results .11
6.7 Melt mass flow rate .11
7 Packaging, marking and instructions and information to be supplied by the
manufacturer .12
7.1 Packaging .12
7.2 Labelling .12
7.3 Declaration of components .
...