Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)

This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

Zahnheilkunde - Endodontische Instrumente - Teil 1: Allgemeine Anforderungen (ISO 3630-1:2019)

Diese Dokument legt allgemeine Anforderungen an und Prüfverfahren für endodontische Instrumente, die für endodontische Anwendungen verwendet werden, z. B. Erweiterer, Kompaktoren, Hilfsinstrumente, Form- und Reinigungsinstrumente sowie Nummernsystem fest. Zusätzlich beschreibt es allgemeine Größen¬bezeichnungen, Farbkennzeichnung, Verpackung und Identifikationssymbole.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 1: Exigences générales (ISO 3630-1:2019)

Le présent document spécifie les exigences générales et les méthodes d'essai relatives aux instruments d'endodontie utilisés en endodontie, par exemple les élargisseurs, les compacteurs, les instruments auxiliaires, les instruments de mise en forme et de nettoyage et le système de codification numérique. En outre, il couvre les désignations générales de dimensions, le code de couleurs, l'emballage et les symboles d'identification.

Zobozdravstvo - Endodontski instrumenti - 1. del: Splošne zahteve (ISO 3630-1:2019)

Ta dokument določa splošne zahteve in preskusne metode za endodontske instrumente, ki se uporabljajo v endodontske namene, npr. za razširjevalnike, kompaktorje, pribor, instrumente za oblikovanje in čiščenje ter sistem za številsko označevanje. Poleg tega zajema splošne oznake velikosti, barvno označevanje, pakiranje in identifikacijske simbole.

General Information

Status
Published
Publication Date
08-Oct-2019
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
09-Oct-2019
Completion Date
09-Oct-2019

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SLOVENSKI STANDARD
SIST EN ISO 3630-1:2019
01-december-2019
Nadomešča:
SIST EN ISO 3630-1:2008
Zobozdravstvo - Endodontski instrumenti - 1. del: Splošne zahteve (ISO 3630-
1:2019)

Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)

Zahnheilkunde - Endodontische Instrumente - Teil 1: Allgemeine Anforderungen (ISO

3630-1:2019)

Médecine bucco-dentaire - Instruments d'endodontie - Partie 1: Exigences générales

(ISO 3630-1:2019)
Ta slovenski standard je istoveten z: EN ISO 3630-1:2019
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 3630-1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3630-1:2019
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SIST EN ISO 3630-1:2019
EN ISO 3630-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-1:2008
English Version
Dentistry - Endodontic instruments - Part 1: General
requirements (ISO 3630-1:2019)

Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 1:

Partie 1: Exigences générales (ISO 3630-1:2019) Allgemeine Anforderungen (ISO 3630-1:2019)

This European Standard was approved by CEN on 4 June 2019.

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, Turkey 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

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-1:2019 E

worldwide for CEN national Members.
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SIST EN ISO 3630-1:2019
EN ISO 3630-1:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 3630-1:2019
EN ISO 3630-1:2019 (E)
European foreword

This document (EN ISO 3630-1:2019) 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 April 2020, and conflicting national standards shall be

withdrawn at the latest by April 2020.

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 3630-1:2008.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 3630-1:2019 has been approved by CEN as EN ISO 3630-1:2019 without any

modification.
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SIST EN ISO 3630-1:2019
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SIST EN ISO 3630-1:2019
INTERNATIONAL ISO
STANDARD 3630-1
Third edition
2019-08
Dentistry — Endodontic
instruments —
Part 1:
General requirements
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 1: Exigences générales
Reference number
ISO 3630-1:2019(E)
ISO 2019
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

3.1 Terms and definitions ....................................................................................................................................................................... 2

3.2 Symbols ......................................................................................................................................................................................................... 3

4 Classification ............................................................................................................................................................................................................ 3

5 Requirements .......................................................................................................................................................................................................... 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Type 1: Standard instruments ................................................................................................................................................... 3

5.2.1 Length........................................................................................................................................................................................ 3

5.2.2 Size designation and diameters .......................................................................................................................... 4

5.2.3 Colour designation ......................................................................................................................................................... 4

5.2.4 Tip shape ................................................................................................................................................................................ 4

5.2.5 Tip length ............................................................................................................................................................................... 5

5.3 Type 2: Taper instruments............................................................................................................................................................ 5

5.3.1 Length........................................................................................................................................................................................ 5

5.3.2 Tip shape ................................................................................................................................................................................ 5

5.3.3 Size designation ................................................................................................................................................................ 6

5.3.4 Designation and diameters ..................................................................................................................................... 6

5.3.5 Taper designation ........................................................................................................................................................... 6

5.3.6 Diameter colour identification............................................................................................................................. 6

5.3.7 Taper colour and ring identification ............................................................................................................... 7

5.4 Type 3: Non-taper instruments ................................................................................................................................................ 7

5.4.1 Length........................................................................................................................................................................................ 7

5.4.2 Size designation and diameters .......................................................................................................................... 7

5.4.3 Colour designation ......................................................................................................................................................... 7

5.5 Type 4: Non-uniform taper instruments .......................................................................................................................... 8

5.5.1 Length........................................................................................................................................................................................ 8

5.5.2 Tip length and angle ..................................................................................................................................................... 8

5.5.3 Size designation ................................................................................................................................................................ 8

5.5.4 Diameter designation and diameters ............................................................................................................. 8

5.5.5 Diameter colour identification............................................................................................................................. 9

5.5.6 Taper colour and ring identification ............................................................................................................... 9

5.6 Type 5: Shape instruments ........................................................................................................................................................... 9

5.6.1 Length........................................................................................................................................................................................ 9

5.6.2 Size designation and diameters .......................................................................................................................... 9

5.6.3 Colour designation ......................................................................................................................................................... 9

5.7 Material ......................................................................................................................................................................................................... 9

5.8 Dimensions ..............................................................................................................................................................................................10

5.8.1 General...................................................................................................................................................................................10

5.8.2 Length.....................................................................................................................................................................................10

5.8.3 Handle and shank .........................................................................................................................................................10

5.9 Mechanical requirements ...........................................................................................................................................................11

5.9.1 Resistance to fracture by twisting and angular deflection .......................................................11

5.9.2 Stiffness (Resistance to bending) ...................................................................................................................11

5.9.3 Handle and shank security ...................................................................................................................................11

5.10 Reprocessing ..........................................................................................................................................................................................12

6 Sampling .....................................................................................................................................................................................................................12

7 Measurement and test methods ........................................................................................................................................................12

7.1 Visual inspection ................................................................................................................................................................................12

© ISO 2019 – All rights reserved iii
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(E)

7.2 Test conditions .....................................................................................................................................................................................12

7.3 Measurement of dimensions ....................................................................................................................................................12

7.3.1 Principle ...............................................................................................................................................................................12

7.3.2 Measuring device ..........................................................................................................................................................12

7.3.3 Procedure ............................................................................................................................................................................12

7.3.4 Taper calculation ..........................................................................................................................................................13

7.4 Resistance to fracture by twisting and angular deflection .............................................................................13

7.4.1 Principle ...............................................................................................................................................................................13

7.4.2 Apparatus ............................................................................................................................................................................13

7.4.3 Procedure ............................................................................................................................................................................14

7.4.4 Expression of results .................................................................................................................................................15

7.5 Stiffness ......................................................................................................................................................................................................15

7.5.1 Principle ...............................................................................................................................................................................15

7.5.2 Apparatus ............................................................................................................................................................................15

7.5.3 Procedure ............................................................................................................................................................................15

7.5.4 Expression of results .................................................................................................................................................16

7.6 Handle or shank security ............................................................................................................................................................16

7.6.1 Principle ...............................................................................................................................................................................16

7.6.2 Apparatus ............................................................................................................................................................................16

7.6.3 Preparation of test sample ...................................................................................................................................16

7.6.4 Procedure ............................................................................................................................................................................16

7.7 Resistance to reprocessing ........................................................................................................................................................17

8 Designation, marking and identification .................................................................................................................................17

8.1 General ........................................................................................................................................................................................................17

8.2 Identification symbols ...................................................................................................................................................................17

9 Packaging ..................................................................................................................................................................................................................18

10 Instructions for use ........................................................................................................................................................................................18

11 Labeling .......................................................................................................................................................................................................................18

Bibliography .............................................................................................................................................................................................................................20

iv © ISO 2019 – All rights reserved
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(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 third edition cancels and replaces the second edition (ISO 3630-1:2008), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— reorganization with the intention of presenting the requirements and test methods for endodontic

instruments in an orderly manner;

— change of the main element of the title of the ISO 3630 series to "Endodontic instruments";

— addition of requirements for the current use of Nickel-Titanium;
— clarification of the option for the handle shape for the manufacturer;
— addition of the new identification symbols in Figure 10.
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.
© ISO 2019 – All rights reserved v
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(E)
Introduction

This document specifies general requirements and test methods for endodontic instruments. Other

parts of the ISO 3630 series provide the specific requirements and test methods for six areas of

endodontics (enlargers, compactors, auxiliary instruments, shaping and cleaning instruments, numeric

coding system and ultrasonic inserts).

With current use of Nickel-Titanium alloys for manufacture of endodontic instruments a need for

adequate expertise in their safe use is recommended. This document does not attempt to provide

information for proper use of any instruments.

The sizes of the endodontic obturating points (cones) specified in ISO 6877 should be aligned with the

corresponding sizes for endodontic instruments specified in all parts of the ISO 3630 series.

vi © ISO 2019 – All rights reserved
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SIST EN ISO 3630-1:2019
INTERNATIONAL STANDARD ISO 3630-1:2019(E)
Dentistry — Endodontic instruments —
Part 1:
General requirements
1 Scope

This document specifies general requirements and test methods for endodontic instruments used

for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning

instruments, and a numeric coding system. In addition, it covers general size designations, color-coding,

packaging, and identification symbols.
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 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 1797, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
ISO 3630-2, Endodontic instruments — Part 2: Enlargers
ISO 3630-3, Endodontic instruments — Part 3: Compactors: pluggers and spreaders
ISO 3630-4, Root canal instruments — Part 4: Auxiliary instruments
ISO 3630-5, Endodontic instruments — Part 5: Shaping and cleaning instruments

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates

and times

ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements

ISO 17664, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 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 http: //www .electropedia .org/
© ISO 2019 – All rights reserved 1
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(E)
3.1 Terms and definitions
3.1.1
endodontic instrument

dental instrument designed to explore, shape, clean and/or help filling a root canal system

3.1.2
standard instrument

endodontic instrument (3.1.1) having a uniform taper of 0,02 mm per millimetre of length of the working

part throughout the range of available sizes

Note 1 to entry: The nominal sizes of endodontic instruments are listed in Table 1.

Note 2 to entry: Some manufacturers may designate taper as a 2-digit number, e.g. ‘02’ or as a percentage, e.g. ‘2 %’.

3.1.3
non-standard instrument

endodontic instrument (3.1.1), which has a tip diameter and/or shape other than that of a endodontic

standard instrument (3.1.2)
3.1.4
taper instrument

endodontic instrument (3.1.1) of which the sizes are determined by the tip sizes and have uniform tapers

of the working part other than 0,02 mm per millimetre of length
3.1.5
non-taper instrument
endodontic instrument (3.1.1) having a cylindrical shape along its long axis
3.1.6
non-uniform taper instrument
endodontic instrument (3.1.1) having more than one taper along the working part
3.1.7
shape instrument

endodontic instrument (3.1.1) having a contoured working part with continuously varying profile

3.1.8
tip

part of the endodontic instrument (3.1.1), which is intended as the point, the shape of which is at the

discretion of the manufacturer
3.1.9
working part
section of an endodontic instrument (3.1.1) which has a cutting surface
3.1.10
shaft

part of the endodontic instrument (3.1.1) between the handle or shank and the working part

3.1.11
handle

part of the endodontic instrument (3.1.1) which is held by the user’s fingers for manipulation of the

instrument in the root canal
3.1.12
shank

part of a rotary, oscillating or reciprocating endodontic instrument (3.1.1) which is designed to fit into

the chuck of a handpiece
2 © ISO 2019 – All rights reserved
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SIST EN ISO 3630-1:2019
ISO 3630-1:2019(E)
3.1.13
operative part
part of the endodontic instrument (3.1.1) from the tip to the handle or shank
3.2 Symbols
For the purposes of this document, the following symbols apply.
D diameter of the projection of the working part at the tip end (reference size)
...

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