EN ISO 3630-2:2023
(Main)Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)
This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 or ISO 3630-7.
This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.
Zahnheilkunde - Endodontische Instrumente - Teil 2: Erweiterer (ISO 3630-2:2023)
Dieses Dokument legt Anforderungen und Prüfverfahren für Erweiterer fest, die in ISO 3630 1, ISO 3630 3, ISO 3630 4, ISO 3630 5, ISO/TR 3630 6 oder ISO 3630 7 nicht enthalten sind.
Dieses Dokument legt Anforderungen an Größe, Kennzeichnung, Produktbezeichnung, Sicherheitsbetrachtungen, und Etikettierung und Verpackung sowie an die Gebrauchsanweisung fest.
Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO 3630-2:2023)
Le présent document spécifie les exigences relatives aux élargisseurs non cités dans l’ISO 3630-1, l’ISO 3630-3, l’ISO 3630-4, l’ISO 3630-5, l’ISO TR 3630-6 ou l’ISO 3630-7.
Le présent document spécifie les exigences concernant la dimension, le marquage, la désignation du produit, les considérations de sécurité, l’étiquetage et l’emballage, ainsi que les instructions d’utilisation.
Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO 3630-2:2023)
Ta dokument določa zahteve za razširjevalnike, ki niso navedeni v standardih, ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 ali ISO 3630-7.
Ta dokument določa posebne zahteve za velikost, označevanje, namembnost izdelka, varnostne napotke, etiketiranje in pakiranje, vključno z navodili za uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO 3630-
2:2023)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)
Zahnheilkunde - Endodontische Instrumente - Teil 2: Erweiterer (ISO 3630-2:2023)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO 3630-
2:2023)
Ta slovenski standard je istoveten z: EN ISO 3630-2:2023
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 3630-2
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2023
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-2:2013
English Version
Dentistry - Endodontic instruments - Part 2: Enlargers
(ISO 3630-2:2023)
Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 2:
Partie 2: Élargisseurs (ISO 3630-2:2023) Erweiterer (ISO 3630-2:2023)
This European Standard was approved by CEN on 24 December 2022.
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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-2:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 3630-2:2023) 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 2023, and conflicting national standards shall
be withdrawn at the latest by August 2023.
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 3630-2:2013.
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 website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 3630-2:2023 has been approved by CEN as EN ISO 3630-2:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 3630-2
Fourth edition
2023-02
Dentistry — Endodontic
instruments —
Part 2:
Enlargers
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 2: Élargisseurs
Reference number
ISO 3630-2:2023(E)
ISO 3630-2:2023(E)
© ISO 2023
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
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or ISO’s member body in the country of the requester.
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Published in Switzerland
ii
ISO 3630-2:2023(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 . 1
4 Classification . 2
4.1 Enlarger Type B1 . 2
4.2 Enlarger Type B2 . 2
4.3 Enlarger Type G . 2
4.4 Enlarger Type M . 2
4.5 Enlarger Type P . 2
5 Requirements . 2
5.1 Materials . 2
5.1.1 Shank . 2
5.1.2 Working part . 3
5.2 Dimensions, designation and number of blades . 3
5.3 Mechanical requirements . 8
5.3.1 Resistance to fracture by twisting and angular deflection . 8
5.3.2 Resistance to bending . 8
5.3.3 Resistance to fatigue . . 8
5.3.4 Fracture location . 8
5.4 Resistance to reprocessing . 9
6 Sampling . 9
7 Testing. 9
7.1 General . 9
7.2 Dimensions . 9
7.2.1 Diameters . . 9
7.2.2 Tip . 9
7.2.3 Shank . 9
7.2.4 Lengths . 9
7.2.5 Blades . 9
7.3 Resistance to fracture by twisting and angular deflection . . 9
7.4 Resistance to bending . 10
7.5 Resistance to fatigue . 10
7.6 Fracture location . 10
7.7 Test report . 11
8 Product information .12
8.1 Marking .12
8.2 Labelling . 12
8.3 Packaging .12
8.4 Instructions for use .12
Bibliography .13
iii
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