EN ISO 6877:2006

Dentistry - Root-canal obturating points (ISO 6877:2006)

ISO 6877:2006 specifies the dimensions and compositional requirements for prefabricated metal or polymeric points or cones suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. It also specifies numerical systems and a colour coding system for designating the sizes.
Dental root-canal obturating points are marketed sterilized or unsterilized. ISO 6877:2006 covers the physical attributes expected of such products as supplied. Requirements for sterility are not included, and any claim that the product is sterile is the responsibility of the manufacturer.

Zahnheilkunde - Wurzelkanalfüllstifte (ISO 6877:2006)

Diese Internationale Norm legt Maße und Anforderungen an die Zusammensetzung von vorgefertigten Wurzelkanalfüllstiften aus Metall oder Kunststoff fest, die zum Füllen des Wurzelkanals dienen, jedoch nicht als Wurzelstifte für Aufbauten verwendet werden. Sie beschreibt auch ein Nummernsystem und ein Farbkennzeichnungssystem zur Größenbezeichnung.
Dentale Wurzelkanalfüllstifte sind in steriler oder nicht steriler Form im Handel erhältlich. In der vorliegenden Internationalen Norm werden die physikalischen Eigenschaften beschrieben, 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 8 f)].

Art dentaire - Cônes d'obturation dentaires pour canaux radiculaires (ISO 6877:2006)

L'ISO 6877:2006 spécifie les exigences relatives à la composition des cônes préfabriqués, métalliques ou à base de polymères, utilisés pour l'obturation des canaux radiculaires, mais non pas comme ancrage d'une restauration coronaire. Elle spécifie également des systèmes numériques et un système de code de couleur pour la désignation des tailles.
Les cônes d'obturation dentaire pour canaux radiculaires sont commercialisés stérilisés ou non stérilisés. L'ISO 6877:2006 couvre les caractéristiques physiques attendues de ces produits tels qu'ils sont fournis. Les exigences relatives à la stérilité ne sont pas incorporées et toute revendication indiquant que le produit est stérile est sous la responsabilité du fabricant.

Zobozdravstvo - Zatič za zapiranje zobnega kanala (ISO 6877:2006)

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2006
• Withdrawal Date: 13-Apr-2025
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-Sep-2021
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 6877:2006 - Dentistry - Root-canal obturating points (ISO 6877:2006)

Relations

• Replaces: EN ISO 6877:1998 - Dental root-canal obturating points (ISO 6877:1995)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 6877:2021 - Dentistry - Endodontic obturating materials (ISO 6877:2021)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN ISO 6877:2000
=RER]GUDYVWYR=DWLþ]D]DSLUDQMH]REQHJDNDQDOD,62
Dentistry - Root-canal obturating points (ISO 6877:2006)
Zahnheilkunde - Wurzelkanalfüllstifte (ISO 6877:2006)
Art dentaire - Cônes d'obturation dentaires pour canaux radiculaires (ISO 6877:2006)
Ta slovenski standard je istoveten z: EN ISO 6877:2006
ICS:
11.060.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 6877
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.060.10 Supersedes EN ISO 6877:1998
English Version
Dentistry - Root-canal obturating points (ISO 6877:2006)
Art dentaire - Cônes d'obturation dentaires pour canaux Zahnheilkunde - Wurzelkanalfüllstifte (ISO 6877:2006)
radiculaires (ISO 6877:2006)
This European Standard was approved by CEN on 23 January 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6877:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 6877:2006) 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 October 2006, and conflicting national
standards shall be withdrawn at the latest by October 2006.

This document supersedes EN ISO 6877:1998.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 6877:2006 has been approved by CEN as EN ISO 6877:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 6877
Second edition
2006-04-01
Dentistry — Root-canal obturating points
Art dentaire — Cônes d'obturation dentaires pour canaux radiculaires

Reference number
ISO 6877:2006(E)
©
ISO 2006
ISO 6877:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 6877:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Requirements . 2
4.1 Points . 2
4.2 Biocompatibility. 2
4.3 Length . 2
4.4 Size designation and taper . 2
4.5 Physical integrity . 4
4.6 Radio-opacity . 4
4.7 Colour coding. 4
5 Procurement of samples. 5
6 Test methods. 5
6.1 Test conditions . 5
6.2 Visual examination . 5
6.3 Length . 5
6.4 Size designation. 6
6.5 Physical integrity . 7
6.6 Radio-opacity for polymeric points . 8
7 Packaging . 9
8 Marking and information to be supplied by manufacturer. 9
Bibliography . 11

ISO 6877:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 6877 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This second edition cancels and replaces the first edition (ISO 6877:1995), which has been technically revised
and a typographical error relating to the size of the specimen required to measure the radio-opacity has been
corrected.
iv © ISO 2006 – All rights reserved

ISO 6877:2006(E)
Introduction
The working group, who have prepared this International Standard have addressed the question of cadmium
in polytransisoprene (gutta-percha) points and on the data obtained have concluded that the amount of
cadmium in polytransisoprene (gutta-percha) points is most likely not intentionally added either as an
aesthetic (colour) agent for the enhancement of the chemical or physical integrity of the points. It has likely
resulted from the contamination of the chemical components in the manufacturing process. Based on the data
obtained this trace amount of cadmium has no health implications.

INTERNATIONAL STANDARD ISO 6877:2006(E)

Dentistry — Root-canal obturating points
1 Scope
This International Standard specifies the dimensions and compositional requirements for prefabricated metal
or polymeric points or cones suitable for use in the obturation of the dental root-canal, but not for support of a
coronal restoration. It also specifies numerical systems and a colour coding system for designating the sizes.
Dental root-canal obturating points are marketed sterilized or unsterilized. This International Standard covers
the physical attributes expected of such products as supplied. Requirements for sterility are not included, and
any claim that the product is sterile is the responsibility of the manufacturer [see 8 f)].
2 Normative references
The following referenced documents are indispensable for the application 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 3665, Photography — Intra-oral dental radiographic film — Specification
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
point
prefabricated metal or polymeric material for use in the obturation of the root-canal
NOTE For the purposes of this International Standard the term “root-canal obturating point” is abbreviated as “point”.
3.2
unit pack
smallest pack of points distributed, containing one or more sizes of point
3.3
standard taper point
point having uniform 2 % taper throughout all the ranges of sizes available
3.4
greater taper point
point having a taper greater than 2 %
3.5
size designation
numerical indication, “000”, of the projected tip diameter, measured in hundredths of a millimetre
ISO 6877:2006(E)
4 Requirements
4.1 Points
Throughout their tapered length, the points shall be smooth and uniform in appearance.
Testing shall be carried out in accordance with 6.2.
4.2 Biocompatibility
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard but it is recommended that, in assessing possible biological or toxicological h
...