EN ISO 3630-1:2008
(Main)Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
ISO 3630-1:2008 specifies general requirements and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments. In addition it covers general size designations, colour coding, packaging and identification symbols.
Zahnheilkunde - Wurzelkanalinstrumente - Teil 1: Allgemeine Anforderungen und Prüfverfahren (ISO 3630-1:2008)
Der vorliegende Teil von ISO 3630 legt allgemeine Anforderungen an und Prüfverfahren für Wurzelkanalinstrumente
für endodontische Anwendungen fest, z. B. Erweiterer, Instrumente zur Formgebung und
Reinigung, Füllungsverdichter sowie Hilfsinstrumente. Zusätzlich enthalten sind allgemeine Größenbezeichnungen,
Farbkennzeichnung, Verpackung und Identifikationssymbole.
Art dentaire - Instruments pour canaux radiculaires - Partie 1: Exigences générales et méthodes d'essai (ISO 3630-1:2008)
L'ISO 3630-1:2007 spécifie les exigences générales et les méthodes d'essai relatives aux instruments pour canaux radiculaires utilisés en endodontie, par exemple élargisseurs, instruments de mise en forme et de nettoyage, condenseurs et instruments auxiliaires. En outre elle couvre les désignations générales de dimensions, le code des couleurs, l'emballage et les symboles d'identification.
Zobozdravstvo - Instrumenti za zobni kanal - 1. del: Osnovne zahteve in preskusne metode (ISO 3630-1:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2008
1DGRPHãþD
SIST EN ISO 3630-1:2000
Zobozdravstvo - Instrumenti za zobni kanal - 1. del: Osnovne zahteve in preskusne
metode (ISO 3630-1:2008)
Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO
3630-1:2008)
Zahnheilkunde - Wurzelkanalinstrumente - Teil 1 : Allgemeine Anforderungen und
Prüfverfahren (ISO 3630-1:2008)
Art dentaire - Instruments pour canaux radiculaires - Partie 1: Exigences générales et
méthodes d'essai (ISO 3630-1:2008)
Ta slovenski standard je istoveten z: EN ISO 3630-1:2008
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 3630-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2008
ICS 11.060.20 Supersedes EN ISO 3630-1:1994
English Version
Dentistry - Root-canal instruments - Part 1: General
requirements and test methods (ISO 3630-1:2008)
Art dentaire - Instruments pour canaux radiculaires - Partie Zahnheilkunde - Wurzelkanalinstrumente - Teil 1:
1: Exigences générales et méthodes d'essai (ISO 3630- Allgemeine Anforderungen und Prüfverfahren (ISO 3630-
1:2008) 1:2008)
This European Standard was approved by CEN on 7 January 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
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COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-1:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Foreword
This document (EN ISO 3630-1:2008) 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 August 2008, and conflicting national standards shall be withdrawn at
the latest by August 2008.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 3630-1:1994.
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 3630-1:2008 has been approved by CEN as a EN ISO 3630-1:2008 without any modification.
INTERNATIONAL ISO
STANDARD 3630-1
Second edition
2008-02-01
Dentistry — Root-canal instruments —
Part 1:
General requirements and test methods
Art dentaire — Instruments pour canaux radiculaires —
Partie 1: Exigences générales et méthodes d'essai
Reference number
ISO 3630-1:2008(E)
©
ISO 2008
ISO 3630-1:2008(E)
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ii © ISO 2008 – All rights reserved
ISO 3630-1:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols. 1
3.1 Terms and definitions. 1
3.2 Symbols . 3
4 Classification. 3
5 Requirements . 3
5.1 General. 3
5.2 Type 1: standard-sized instruments . 3
5.3 Type 2: taper-sized instruments. 5
5.4 Type 3: shape-sized instruments. 6
5.5 Type 4: non-taper-sized instruments. 7
5.6 Type 5: non-uniform taper-sized instruments . 8
5.7 Material . 9
5.8 Dimensions. 9
5.9 Mechanical requirements. 9
5.10 Chemical requirements . 10
6 Sampling. 10
7 Testing . 10
7.1 Visual inspection . 10
7.2 Test conditions . 10
7.3 Measurement of dimensions . 11
7.4 Resistance to fracture by twisting and angular deflection. 11
7.5 Stiffness. 13
7.6 Handle and shank security . 14
7.7 Corrosion test . 14
7.8 Heat effects of sterilization . 15
8 Designation, marking and identification . 16
8.1 General. 16
8.2 Identification symbols. 16
9 Packaging . 16
10 Manufacturer's instructions for use. 16
11 Labelling . 17
Bibliography . 18
ISO 3630-1:2008(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 3630-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
This second edition cancels and replaces the first edition (ISO 3630-1:1992), which has been technically
revised.
ISO 3630 consists of the following parts, under the general title Dentistry — Root-canal instruments:
⎯ Part 1: General requirements and test methods
⎯ Part 2: Enlargers
⎯ Part 3: Condensers, pluggers and spreaders
⎯ Part 4: Auxiliary instruments
iv © ISO 2008 – All rights reserved
ISO 3630-1:2008(E)
Introduction
The reorganization of ISO 3630 is intended to present the requirements and test methods for root-canal
instruments in an orderly manner. This part of ISO 3630 defines general requirements and test methods.
Subsequent parts provide the specific requirements and test methods, if applicable, for two areas of
endodontic procedures. These parts are enlargers, condensers and auxiliary instruments.
With current use of nickel-titanium (Ni-Ti) alloys for manufacture of root canal instruments a need for adequate
expertise in their safe use is recommended. Instruments made of Ni-Ti can be easily broken near the tip if
manufacturer's cautions are not understood and practiced. This part of ISO 3630 does not attempt to provide
information for proper use of any instruments.
[4]
The sizes of the root-canal obturating points (cones) specified in ISO 6877 have to be aligned with the
corresponding sizes for root-canal instruments specified in ISO 3630.
INTERNATIONAL STANDARD ISO 3630-1:2008(E)
Dentistry —
...
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