EN ISO 3630-4:2023
(Main)Dentistry - Endodontic instruments - Part 4: Auxiliary instruments (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 - Instrumenti za zobni kanal - 4. del: Pomožni instrumenti (ISO/FDIS 3630-4:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 3630-4:2022
01-maj-2022
Zobozdravstvo - Instrumenti za zobni kanal - 4. del: Pomožni instrumenti (ISO/DIS
3630-4:2022)
Dentistry - Endodontic instruments - Part 4: Auxiliary instruments (ISO/DIS 3630-4:2022)
Zahnheilkunde – Wurzelkanalinstrumente – Teil 4: Hilfsinstrumente (ISO/DIS 3630-
4:2022)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 4: Instruments auxiliaires
(ISO/DIS 3630-4:2022)
Ta slovenski standard je istoveten z: prEN ISO 3630-4
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 3630-4:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 3630-4:2022
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oSIST prEN ISO 3630-4:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3630-4
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-03-17 2022-06-09
Dentistry — Endodontic instruments —
Part 4:
Auxiliary instruments
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 4: Instruments auxiliaires
ICS: 11.060.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 3630-4:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 3630-4:2022
ISO/DIS 3630-4:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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oSIST prEN ISO 3630-4:2022
ISO/DIS 3630-4:2022(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 (Type 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 . . 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 Diameters . . 10
7.2.3 Barbed broaches . 10
7.2.4 Taper calculation . 11
7.3 Paste carriers (Type 2 instruments) . 11
7.3.1 Number of spirals . 11
7.3.2 Resistance to cyclic fatigue . 11
8 Labels .11
8.1 Marking . 11
8.2 Labeling . . .12
8.3 Packaging .12
9 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
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oSIST prEN ISO 3630-4:2022
ISO/DIS 3630-4:2022(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 documents 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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
This second edition cancels and replaces the first edition (ISO 3630-4:2009), which has been technically
revised.
The main changes compared to the previous edition are as follows:
Removal of rasps requirements in this standard.
ISO 3630 consists of the following parts, under the general title Dentistry — Endodontic instruments:
— Part 1: General requirements and test methods
— Part 2: Enlargers
— Part 3: Condensers, pluggers and spreaders
— Part 5: Shaping and cleaning instruments
— Part 6: Numeric coding system
— Part 7: Ultrasonic inserts
— Part 8: Accuracy of apex locator
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oSIST prEN ISO 3630-4:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 3630-4:2022(E)
Dentistry — Endodontic 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 and which are 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 labeling.
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, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
ISO 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 3630-2, Dentistry — Endodontic instruments — Part 2: Enlargers
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 terminological 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
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
1
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oSIST prEN ISO 3630-4:2022
ISO/DIS 3630-4:2022(E)
3.5
height of barb
height measured perpendicularly from the outside of the core to the tip of the barb
3.6
core diameter of the instrument
diameter of the solid portion of the barbed broach
3.7
delivery device
powered endodontic instrument designed for placing thermoplastic obturation material into a root
canal
3.8
cannula
tube connected to thermoplastic delivery device
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 diameter of core (projected core for paste carriers) measured at the tip
d diameter of core or working part at length l
n n
d diameter of core or working part at length l
w w
h height of barb
l tip length, measured from tip point of broaches to base of first barb
b
l length for measuring point d
n n
l length of operative part
op
l total length of instrument
tot
l length of working part, measured from the tip
w
d outer diameter of cannula
od
d inner diameter of cannula
id
2
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oSIST prEN ISO 3630-4:2022
ISO/DIS 3630-4:2022(E)
5 Requirements
5.1 Material
The material for the endodontic instrument and for the handle or shank is left to the discretion of the
manufacturer.
The handle or shank security shall meet the requirement specified in ISO 3630-1:2019, 5.9.3.
5.2 Dimensions
5.2.1 General
The nominal diameters, selected by the manufacturer, represent the sizes of the instrument and shall
meet the requirements included in Figures 1 to 4 and Tables 1 to 4.
The length of the operative part of the endodontic instrument shall be the nominal length as specified
by the manufacturer with a tolerance of ± 0,5 mm.
The dimensions of the shank shall meet the requirements of ISO 1797.
5.2.2 Barbed broaches (Type 1 instruments)
Type 1 instruments shall meet the dimensions and tolerances specified in Figure 1 and Table 1.
The shape of the tip and the design of the handle for hand use are at the discretion of the manufacturer.
The working length l shall be at le
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