EN ISO 3630-4:2009
(Main)Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009)
Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009)
ISO 3630-4:2009 specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures not cited in ISO 3630-1, 3630-2, 3630-3 or 3630-5.
ISO 3630-4:2009 specifies requirements for size, product designation, safety considerations, instructions and labelling.
Zahnheilkunde - Wurzelkanalinstrumente - Teil 4: Hilfsinstrumente (ISO 3630-4:2009)
Dieser Teil von ISO 3630 legt Anforderungen und Prüfverfahren für handgeführte oder mechanisch betätigte
Wurzelkanalinstrumente fest, die für Wurzelkanalverfahren verwendet werden, die nicht in ISO 3630-1,
ISO 3630-2, ISO 3630-3 oder ISO 3630-5 aufgeführt sind.
Dieser Teil von ISO 3630 beschreibt Anforderungen an Größe, Produktbezeichnung, Sicherheitsüberlegungen
sowie Gebrauchsanweisung und Kennzeichnung.
Art dentaire - Instruments pour canaux radiculaires - Partie 4: Instruments auxiliaires (ISO 3630-4:2009)
L'ISO 3630-4:2009 spécifie les exigences et les méthodes d'essai relatives aux instruments à main ou mécaniques servant aux obturations canalaires, non mentionnés dans l'ISO 3630‑1, l'ISO 3630‑2, l'ISO 3630-3 ou l'ISO 3630-5.
L'ISO 3630-4:2009 spécifie les exigences concernant les dimensions, la désignation du produit, les précautions de sécurité, les instructions ainsi que l'étiquetage.
Zobozdravstvo - Instrumenti za zobni kanal - 4. del: Pomožni instrumenti (ISO 3630-4:2009)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
Zobozdravstvo - Instrumenti za zobni kanal - 4. del: Pomožni instrumenti (ISO 3630
-4:2009)
Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009)
Zahnheilkunde - Wurzelkanalinstrumente - Teil 4: Hilfsinstrumente (ISO 3630-4:2009)
Art dentaire - Instruments pour canaux radiculaires - Partie 4: Instruments auxiliaires
(ISO 3630-4:2009)
Ta slovenski standard je istoveten z: EN ISO 3630-4:2009
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 3630-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2009
ICS 11.060.20
English Version
Dentistry - Root canal instruments - Part 4: Auxiliary instruments
(ISO 3630-4:2009)
Art dentaire - Instruments pour canaux radiculaires - Partie Zahnheilkunde - Wurzelkanalinstrumente - Teil 4:
4: Instruments auxiliaires (ISO 3630-4:2009) Hilfsinstrumente (ISO 3630-4:2009)
This European Standard was approved by CEN on 20 June 2009.
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-4:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 3630-4:2009) 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 January 2010, and conflicting national standards shall be withdrawn at
the latest by January 2010.
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.
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 3630-4:2009 has been approved by CEN as a EN ISO 3630-4:2009 without any modification.
INTERNATIONAL ISO
STANDARD 3630-4
First edition
2009-07-01
Dentistry — Root canal instruments —
Part 4:
Auxiliary instruments
Art dentaire — Instruments pour canaux radiculaires —
Partie 4: Instruments auxiliaires
Reference number
ISO 3630-4:2009(E)
©
ISO 2009
ISO 3630-4:2009(E)
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ii © ISO 2009 – All rights reserved
ISO 3630-4:2009(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols. 1
3.1 Terms and definitions. 1
3.2 Symbols . 2
4 Classification. 2
5 Requirements . 3
5.1 Material . 3
5.2 Dimensions. 3
5.3 Colour designation and size marking with rings. 6
5.4 Mechanical requirements. 7
5.5 Resistance to corrosion. 9
5.6 Heat effects of sterilization . 9
6 Sampling. 9
7 Testing . 9
7.1 General. 9
7.2 Dimensions. 9
8 Designation, marking and identification . 10
9 Packaging . 10
10 Labelling . 10
Bibliography . 11
ISO 3630-4:2009(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 3630-4 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
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
The following part is under preparation:
⎯ Part 5: Shaping and cleaning instruments
iv © ISO 2009 – All rights reserved
INTERNATIONAL STANDARD ISO 3630-4:2009(E)
Dentistry — Root canal instruments —
Part 4:
Auxiliary instruments
1 Scope
This part of ISO 3630 specifies requirements and test methods for hand-held or mechanically operated
instruments for performing root canal procedures not cited in ISO 3630-1, 3630-2, 3630-3 or 3630-5.
This part of ISO 3630 specifies requirements for size, product designation, safety considerations, instructions
and labelling.
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 1797-1, Dental rotary instruments — Shanks — Part 1: Shanks made of metals
ISO 1797-2, Dental rotary instruments — Shanks — Part 2: Shanks made of plastics
ISO 1942, Dentistry — Vocabulary
ISO 3630-1:2008, Dentistry — Root-canal instruments — Part 1: General requirements and test methods
ISO 3630-2:2000, Dental root-canal instruments — Part 2: Enlargers
3 Terms, definitions and symbols
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the following
apply.
3.1.1
barbed broach
root-canal instrument with barbs designed for removing the pulp tissue
3.1.2
rasp
root-canal instrument in which sharp prominences have been formed on the working part and which is
designed to enlarge a root canal by abrasive action
3.1.3
paste carrier
root-canal instrument designed for conveying filling material or medicaments into a root canal
ISO 3630-4:2009(E)
3.1.4
root-canal explorer
root-canal instrument designed for exploring the root canal system
3.1.5
cotton broach
root-canal instrument used with cotton for drying root canals or placing medicaments
3.1.6
height of barb
height measured perpendicularly from the outside of the core to the barbed tip
3.1.7
core diameter of the instrument
diameter of the solid portion of the barbed broach or rasp
3.2 Symbols
For the purposes of this document, the following symbols apply.
d diameter of core or working part at length l ;
1 1
d diameter of core or working part at length l ;
2 2
d diameter of core or working part at length l ;
3 3
h height of barb;
l tip length, measured from tip point (for Type 1 and Type 2) to base of first barb;
l length for measuring point d ;
2 2
l length for measuring point d and minimum length of working part, distance from the tip of the
3 3
instrument to the tip of the last barb;
l length of operative part.
4 Classification
For the purposes of this document, root-canal instruments are classified according to the shape and intended
endodontic application of the instrument as follows:
⎯ Type 1: barbed broaches;
⎯ Type 2: rasps;
⎯ Type 3: paste carriers;
⎯ Type 4: explorers and cotton broaches.
2 © ISO 2009 – All rights reserved
ISO 3
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