EN ISO 6877:2021

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
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below or ISO’s member body in the country of the requester.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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 .13
Annex A (normative) .14
Melt mass-flow rate test
Bibliography .17
ISO 6877:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and Restorative Materials, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 6877:2006), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— use of “endodontic” rather than “root canal” for the terminology;
— inclusion of points having a non-uniform taper;
— inclusion of thermoplastic materials not in the form of a point;
— standardization to the use of D, d and d for measurements of endodontic points at the projection
3 16
of the tip, 3 mm or 16 mm from the tip of a point;
— harmonization of D, d and d with the ISO 3630 series;
3 16
— reconsidering tests methods;
— addition of ISO 13116 for test method for determining radiopacity of material as a normative
reference;
— augmenting the packaging requirements for providing information;
— addition of an annex for measuring the melt-flow rate of thermoplastic materials that are not
supplied in point form.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved

ISO 6877:2021(E)
Introduction
The following information should be taken into account when using this document: specific qualitative
and quantitative test methods for demonstrating freedom from unacceptable biological risks are not
included in this document but it is recommended that, for the assessment of such biological risks,
reference be made to ISO 7405 and ISO 10993-1. No performance limits are provided in this document
for melt mass flow rate, but they might be added in the future.
INTERNATIONAL STANDARD ISO 6877:2021(E)
Dentistry — Endodontic obturating materials
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 13116, Dentistry — Test method for determining radio-opacity of materials
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org
3.1
endodontic obturating material
substance intended as a definitive product to fill a prepared root canal system, usually a combination of
points (3.2) and endodontic sealer (3.15)
ISO 6877:2021(E)
3.2
point
preformed metal, preformed polymeric-coated metal, and polymeric cones for use in the obturation of
a root canal system
Note 1 to entry: For the purposes of this document, the term “endodontic obturating point (cone)” is abbreviated
as “point”.
3.3
size designation
numerical indication, “000”, of the projected tip diameter, measured in hundredths of a millimetre
3.4
taper
percentage increase in diameter along the length of the point (3.2)
EXAMPLE 02 taper represents a 2 % increase in diameter along the length of the point.
3.5
standard point
point (3.2) having a uniform 02 taper over the first 16 mm
3.6
greater taper point
point (3.2) having a uniform taper greater than 02 over the first 16 mm
3.7
variable taper point
point (3.2) which has a taper that varies over the first 16 mm
3.8
auxiliary point
point (3.2) excepting standard point (3.5), greater taper point (3.6) and variable taper point (3.7)
3.9
carrier-based obturating device
point (3.2) designed to obturate a root canal with thermoplastic polymeric material coated on a core
material, usually in the shape of a point (3.2)
Note 1 to entry: The core material remains in the canal or may be removed after carrying the thermoplastic
material.
3.10
injection material
substance supplied in non-conical form, such as pellets for injection after being warmed to a
thermoplastic state
3.11
injection system
instrument designed to obturate a root canal with thermoplasticized injection material (3.9) using an
injection equipment or device
3.12
melt mass-flow rate
MFR
measure of flow through a capillary of a thermoplastic polymer at a particular temperature, measured
in grams per unit time at a given force
3.13
unit pack
smallest pack of points distributed, containing one or more sizes of points (3.2)
2 © ISO 2021 – All rights reserved

ISO 6877:2021(E)
3.14
radiopacity
property of obstructing the passage of radiant energy, such as x-rays, through the representative areas
appearing grey or white on the exposed film or sensor image
3.15
endodontic sealer
material intended to permanently seal the root canal dentine from the periapical tissue usually in
combination with a solid or semi-solid core material [endodontic obturating material (3.1)], to fill voids
and to seal root canals during orthograde obturation
4 Requirements
4.1 Appearance
Throughout the tapered length, the point shall be smooth and uniform in appearance, free from
extraneous matter. Test according to 6.2.
4.2 Length
Unless otherwise stated by the manufacturer, the overall length shall be not less than 28 mm. Test
according to 6.3.
4.3 Size designation and taper
4.3.1 General
The designation shall be in the form of a five-digit numerical set, having two parts: 000 XX, where 000
corresponds to the size designation and XX corresponds to the two significant figures of the taper per
cent. For example, a 2 % taper is designated as 02.
The diameter tolerance of points at d (see Figure 1) shall be:
— ±0,02 mm for metallic points (cones),
— ±0,05 mm for polymeric points or carrier-based obturating devices of sizes 008 to 025,
— ±0,07 mm for polymeric points of carrier-based obturating devices of sizes 030 to 140.
The tolerances of 0,05 and 0,07 are not applicable to D.
4.3.2 Standard points
a) The taper of the points shall be uniform for a minimum of 16 mm from the tip (see Figure 1),
increasing at 2 % (02) along their length.
b) The size designation of standard polymer points or carrier-based obturating devices shall be in
accordance with the numbering system shown in Table 1.
Test according to 6.4.2, and calculate the taper as described in 6.4.3.
ISO 6877:2021(E)
Key
D diameter of the projection of the point at the tip
d diameter at 3 mm from tip
d diameter at 16 mm from tip
l total length of the instrument
tot
NOTE 1 The diameters D, d and d are expressed in millimetres
3 16
NOTE 2 Table 1 gives values of D, d and d for each size of standard points, not carrier-based obturation
3 16
devices.
NOTE 3 The exact shape of the tip is left t
...