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

Status
Published
Publication Date
14-Feb-2023
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
15-Feb-2023
Completion Date
15-Feb-2023

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SLOVENSKI STANDARD
SIST EN ISO 3630-2:2023
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
SIST EN ISO 3630-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3630-2:2023

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SIST EN ISO 3630-2:2023


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.

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SIST EN ISO 3630-2:2023
EN ISO 3630-2:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 3630-2:2023
EN ISO 3630-2:2023 (E)
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.


3

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SIST EN ISO 3630-2:2023

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SIST EN ISO 3630-2:2023
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 2023

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SIST EN ISO 3630-2:2023
ISO 3630-2:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 2023 – All rights reserved

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SIST EN ISO 3630-2:2023
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
© ISO 2023 – All rights reserved

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SIST EN ISO 3630-2:2023
ISO 3630-2:2023(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 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 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 fourth edition cancels and replaces the third edition (ISO 3630-2:2013), which has been technically
revised.
The main changes are as follows:
— symbols have been redefined;
— the test method has been redefined;
— this document has been harmonized with other parts of the ISO 3630 series.
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
  © ISO 2023 – All rights reserved

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...

SLOVENSKI STANDARD
oSIST prEN ISO 3630-2:2022
01-marec-2022
Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO/DIS 3630-
2:2022)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO/DIS 3630-2:2022)
Zahnheilkunde– Endodontische Instrumente– Teil2: Erweiterer (ISO/DIS 3630-2:2022)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 2 : Élargisseurs (ISO/DIS
3630-2:2022)
Ta slovenski standard je istoveten z: prEN ISO 3630-2
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 3630-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 3630-2:2022

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oSIST prEN ISO 3630-2:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3630-2
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-01-13 2022-04-07
Dentistry — Endodontic instruments —
Part 2:
Enlargers
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 2: Élargisseurs
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,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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 3630-2:2022(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 3630-2:2022
ISO/DIS 3630-2:2022(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
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 2022 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(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
5.2 Dimensions, designation and number of blades . 3
5.2.1 General . 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 . 8
6 Sampling . 9
7 Testing. 9
7.1 General . 9
7.2 Dimensions . 9
7.2.1 Diameters . . 9
7.2.2 Tip . 10
7.2.3 Shank . 10
7.2.4 Lengths . 10
7.2.5 Blades . 10
7.3 Resistance to fracture by twisting and angular deflection . . 10
7.4 Resistance to bending . 10
7.5 Resistance to fatigue . 10
7.6 Fracture location . 10
7.7 Report clause . .12
8 Label .13
8.1 Marking . 13
8.2 Labeling . . .13
8.3 Packaging . 13
9 Instructions for use . .13
Bibliography .14
iii
© ISO 2022 – All rights reserved

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oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 3630-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments, Working Group 9 Endodontic instruments.
This fourth edition cancels and replaces the third edition (ISO 3630-2:2013), which has been technically
revised.
The following changes were made:
— redefinition of the symbols
— redefinition of the test method
— harmonization with other parts of the 3630 series
ISO 3630 consists of the following parts, under the general title Dentistry — Endodontic instruments:
— Part 1: General requirements
— Part 2: Enlargers
— Part 3: Compactors: pluggers and spreaders
— Part 4: Auxiliary instruments
— Part 5: Shaping and cleaning instruments
— Part 6: Numeric coding system
— Part 7: Ultrasonic inserts
— Part 8: Accuracy of apex locator
iv
  © ISO 2022 – All rights reserved

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oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not
included in this International Standard but it is recommended that, in assessing possible biological or
toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.
The nominal size (D) is not utilized in this document because of the nature of the enlargers. Therefore,
d represents the nominal size for this document only.
m
v
© ISO 2022 – All rights reserved

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oSIST prEN ISO 3630-2:2022

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oSIST prEN ISO 3630-2:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 3630-2:2022(E)
Dentistry — Endodontic instruments —
Part 2:
Enlargers
1 Scope
This part of ISO 3630 specifies requirements for enlargers not cited in ISO 3630-1, ISO 3630-3,
ISO 3630-4, ISO 3630-5, ISO 3630-6 or ISO 3630-7. This part of ISO 3630 specifies requirements for size,
marking, product designation, safety considerations, and their labeling and packaging, including the
instructions for use.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
3 Terms, definitions and symbols
3.1 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 data basis for use in standardi
...

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