EN ISO 3630-4:2023

Dentistry - Endodontic instruments - Part 4: Auxiliary instruments (ISO 3630-4:2023)

This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product designation, safety considerations, instructions and labelling.

Zahnheilkunde - Wurzelkanalinstrumente - Teil 4: Hilfsinstrumente (ISO 3630-4:2023)

Dieses Dokument legt Anforderungen und Prüfverfahren für handgehaltene oder mechanisch betriebene Hilfsinstrumente zur Durchführung von Wurzelkanalverfahren wie Exstirpationsnadeln, Wurzelfüller, Wattenadeln und Kanülen fest. Dieses Dokument legt Anforderungen an Größe, Produktbezeichnung, Sicherheitsüberlegungen sowie Gebrauchsanweisung und Kennzeichnung fest.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 4: Instruments auxiliaires (ISO 3630-4:2023)

Le présent document spécifie les exigences et les méthodes d’essai relatives aux instruments auxiliaires à main ou mécaniques servant aux interventions sur les canaux radiculaires, tels que les broches barbelées, les bourre-pâtes, les sondes exploratrices, les broches porte-coton et les canules. Le présent document spécifie les exigences relatives à la taille, à la désignation du produit, aux considérations de sécurité, aux instructions ainsi qu’à l’étiquetage.

Zobozdravstvo - Endodontski instrumenti - 4. del: Pomožni instrumenti (ISO 3630-4:2023)

Ta dokument določa zahteve in preskusne metode za ročne ali mehansko upravljane pomožne instrumente za izvajanje posegov na koreninskih kanalih, kot so živčne igle, nosilci za paste, raziskovalni pripomočki, igle za vato in kanile.
Ta dokument določa zahteve za velikost, namembnost izdelka, varnostne vidike, navodila in etiketiranje.

General Information

• Status: Published
• Publication Date: 22-Aug-2023
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Aug-2023
• Completion Date: 23-Aug-2023
• Ref Project: SIST EN ISO 3630-4:2023 - Dentistry - Endodontic instruments - Part 4: Auxiliary instruments (ISO 3630-4:2023)

Relations

• Replaces: EN ISO 3630-4:2009 - Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2023
Nadomešča:
SIST EN ISO 3630-4:2009
Zobozdravstvo - Endodontski instrumenti - 4. del: Pomožni instrumenti (ISO 3630-
4:2023)
Dentistry - Endodontic instruments - Part 4: Auxiliary instruments (ISO 3630-4:2023)
Zahnheilkunde - Wurzelkanalinstrumente - Teil 4: Hilfsinstrumente (ISO 3630-4:2023)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 4: Instruments auxiliaires
(ISO 3630-4:2023)
Ta slovenski standard je istoveten z: EN ISO 3630-4:2023
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 3630-4
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2023
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-4:2009
English Version
Dentistry - Endodontic instruments - Part 4: Auxiliary
instruments (ISO 3630-4:2023)
Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Wurzelkanalinstrumente - Teil 4:
Partie 4: Instruments auxiliaires (ISO 3630-4:2023) Hilfsinstrumente (ISO 3630-4:2023)
This European Standard was approved by CEN on 24 June 2023.

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 3630-4:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 3630-4:2023) 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 February 2024, and conflicting national standards
shall be withdrawn at the latest by February 2024.
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 3630-4:2009.
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 3630-4:2023 has been approved by CEN as EN ISO 3630-4:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 3630-4
Second edition
2023-08
Dentistry — Endodontic
instruments —
Part 4:
Auxiliary instruments
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 4: Instruments auxiliaires
Reference number
ISO 3630-4:2023(E)
ISO 3630-4:2023(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
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 3630-4:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification and symbols . 2
4.1 Classification . 2
4.2 Symbols . 2
5 Requirements . 3
5.1 Material . 3
5.2 Dimensions . 3
5.2.1 General . 3
5.2.2 Barbed broaches — Type 1 instruments . 3
5.2.3 Paste carriers — Type 2 instruments . 4
5.2.4 Explorers and cotton broaches — Type 3 instruments . 5
5.2.5 Cannulae — Type 4 instruments . 6
5.3 Colour designation and size marking with rings . 7
5.4 Mechanical requirements . 7
5.4.1 Resistance to fracture by twisting (torque) and angular deflection —
Types 1 and 3 . 7
5.4.2 Stiffness — Resistance to bending — Types 1 and 3 . 8
5.4.3 Handle or shank security — Types 1, 2 and 3 instruments . 8
5.4.4 Resistance to fatigue — Type 2 . 8
5.4.5 Resistance to breakage or cracking — Type 4. 9
5.5 Reprocessing . 9
5.6 Heat effects of sterilization . 9
5.6.1 General . 9
5.6.2 Single-use instruments (supplied non-sterile) . 9
5.6.3 Multi-use instruments . 9
6 Sampling . 9
7 Testing.10
7.1 General . 10
7.2 Dimensions . 10
7.2.1 General . 10
7.2.2 Barbed broaches . 10
7.2.3 Paste carriers — Type 2 instruments . 11
8 Product information .11
8.1 Marking . 11
8.2 Labelling . 12
8.3 Packaging .12
8.4 Instructions for use .12
Annex A (normative) Test method for resistance of cannula to breakage or cracking .13
Annex B (normative) Test method for resistance of cannula to corrosion .18
Bibliography .19
iii
ISO 3630-4:2023(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
...