EN ISO 3630-4:2023

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: +41 22 749 01 11
Email: copyright@iso.org
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 Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4,
Dental instruments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 3630-4:2009), which has been technically
revised.
The main changes are as follows:
— rasps requirements have been removed;
— a cyclic fatigue test of paste carriers has been added;
— the term cannula has been added;
— the cannula symbol has changed;
— Annexes A and B have been added.
A list of all parts in the ISO 3630 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
INTERNATIONAL STANDARD ISO 3630-4:2023(E)
Dentistry — Endodontic instruments —
Part 4:
Auxiliary instruments
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
ISO 3630-1:2019, Dentistry — Endodontic instruments — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
barbed broach
endodontic instrument with barbs designed for removing the pulp tissue
3.2
paste carrier
endodontic instrument designed for conveying filling material or medicaments into a root canal system
3.3
explorer
endodontic instrument designed for exploring the root canal system
3.4
cotton broach
endodontic instrument used with cotton for drying root canals or placing medicaments
3.5
instrument core
portion of endodontic instrument that is the centre of the working part
ISO 3630-4:2023(E)
3.6
core diameter of the instrument
diameter of the solid portion of a barbed broach (3.1)
3.7
height of barb
height measured perpendicularly from the outside of the instrument core to the tip of the barb of a
barbed broach (3.1)
3.8
thermoplastic delivery device
powered endodontic instrument designed for placing thermoplastic obturation material into a root
canal system
3.9
cannula
tube, connected to a thermoplastic delivery device (3.8) to deliver the thermoplastic obturation material
into a root canal system
4 Classification and symbols
4.1 Classification
For the purposes of this document, endodontic instruments are grouped according to the shape and
intended endodontic application of the instrument as follows:
— type 1: barbed broaches;
— type 2: paste carriers;
— type 3: explorers and cotton broaches;
— type 4: cannulae.
4.2 Symbols
For the purposes of this document, the following symbols apply.
D core diameter of the instrument (projected core for paste carriers) measured at the tip
d core diameter of the instrument or working part measured from the tip at length l
m m
d core diameter of the instrument or working part measured from the tip at length l
n n
d core diameter of the instrument or operative part at length l
op op
d core diameter of the instrument or working part measured from the tip at length l
w w
h height of barb
l tip length, measured from the tip of t
...