EN ISO 3630-2:2013

Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013)

ISO 3630-2:2013 specifies requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4 or ISO 3630-5.
ISO 3630-2:2013 specifies requirements for size, marking, product designation, safety considerations, and their labelling and packaging, including the instructions for use.

Zahnheilkunde - Endodontische Instrumente - Teil 2: Erweiterer (ISO 3630-2:2013)

Dieser Teil der ISO 3630 legt Anforderungen und Prüfverfahren für Erweiterer fest, die in ISO 3630 1, ISO 3630 3, ISO 3630 4 oder 3630 5 nicht enthalten sind.
Dieser Teil von ISO 3630 beschreibt Anforderungen an Größe, Kennzeichnung, Produktbezeichnung, Sicherheitsüber¬legungen, Beschriftung und Verpackung sowie an die Gebrauchsanweisung.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO 3630-2:2013)

L'ISO 3630-2:2013 spécifie les exigences spécifiques relatives aux élargisseurs non cités dans l'ISO 3630‑1, l'ISO 3630‑3, l'ISO 3630‑4 ou l'ISO 3630‑5.
L'ISO 3630-2:2013 spécifie les exigences relatives à la dimension, au marquage, à la désignation du produit, aux considérations de sécurité, à l'étiquetage et à l'emballage, y compris aux instructions d'utilisation.

Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO 3630-2:2013)

Ta del standarda ISO 3630 določa posebne zahteve in preskusne metode za razširjevalnike, ki niso navedeni v standardih ISO 3630-1, 3630-3, 3630-4 ali 3630-5. Ta del standarda ISO 3630 določa posebne zahteve za velikost, označevanje, namembnost izdelka, varnostne napotke, etiketiranje in pakiranje, vključno z navodili za uporabo.

General Information

• Status: Withdrawn
• Publication Date: 30-Jul-2013
• Withdrawal Date: 14-Feb-2023
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 3630-2:2013 - Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013)

Relations

• Replaces: EN ISO 3630-2:2000 - Dental root-canal instruments - Part 2: Enlargers (ISO 3630-2:2000)
• Effective Date: 24-Apr-2013
• Replaced By: EN ISO 3630-2:2023 - Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)
• Effective Date: 07-Nov-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3630-2:2013
01-september-2013
1DGRPHãþD
SIST EN ISO 3630-2:2001
Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO 3630-
2:2013)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013)
Wurzelkanalinstrumente - Teil 2: Erweiterer (ISO 3630-2:2013)

Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO 3630-

2:2013)
Ta slovenski standard je istoveten z: EN ISO 3630-2:2013
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 3630-2:2013 en

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

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SIST EN ISO 3630-2:2013
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SIST EN ISO 3630-2:2013
EUROPEAN STANDARD
EN ISO 3630-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2013
ICS 11.060.20 Supersedes EN ISO 3630-2:2000
English Version
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO
3630-2:2013)

Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 2:

Partie 2: Élargisseurs (ISO 3630-2:2013) Erweiterer (ISO 3630-2:2013)
This European Standard was approved by CEN on 11 April 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-2:2013: E

worldwide for CEN national Members.
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SIST EN ISO 3630-2:2013
EN ISO 3630-2:2013 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 3630-2:2013
EN ISO 3630-2:2013 (E)
Foreword

This document (EN ISO 3630-2:2013) 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 October 2013, and conflicting national standards shall be withdrawn at

the latest by October 2013.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 3630-2:2000.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 3630-2:2013 has been approved by CEN as EN ISO 3630-2:2013 without any modification.

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SIST EN ISO 3630-2:2013
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SIST EN ISO 3630-2:2013
INTERNATIONAL ISO
STANDARD 3630-2
Third edition
2013-04-15
Dentistry — Endodontic
instruments —
Part 2:
Enlargers
Médecine bucco-dentaire — Instruments d’endodontie —
Partie 2: Élargisseurs
Reference number
ISO 3630-2:2013(E)
ISO 2013
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SIST EN ISO 3630-2:2013
ISO 3630-2:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013

All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
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SIST EN ISO 3630-2:2013
ISO 3630-2:2013(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 ......................................................................................................................................................................................................... 2

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

5.3 Mechanical requirements .............................................................................................................................................................. 9

6 Sampling .....................................................................................................................................................................................................................10

7 Testing ..........................................................................................................................................................................................................................10

7.1 General ........................................................................................................................................................................................................10

7.2 Dimensions ..............................................................................................................................................................................................10

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

7.4 Resistance to bending ....................................................................................................................................................................11

7.5 Resistance to fatigue .......................................................................................................................................................................11

7.6 Fracture location ................................................................................................................................................................................11

8 Designation, marking and identification .................................................................................................................................13

9 Packaging ..................................................................................................................................................................................................................14

10 Labelling .....................................................................................................................................................................................................................14

Bibliography .............................................................................................................................................................................................................................15

© ISO 2013 – All rights reserved iii
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SIST EN ISO 3630-2:2013
ISO 3630-2:2013(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.

This third edition cancels and replaces the second edition (ISO 3630-2:2000), which has been

technically revised.
The following changes were made:
a) tolerances for diameter measurements were aligned;
b) test procedures were aligned with ISO 3630-1.

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 4: Auxiliary instruments
— Part 5: Shaping and cleaning instruments
iv © ISO 2013 – All rights reserved
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SIST EN ISO 3630-2:2013
ISO 3630-2:2013(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.

Attention is drawn to ISO 6360 (all parts) which specifies a 15-digit number for the identification of

dental rotary instruments of all types.
© ISO 2013 – All rights reserved v
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SIST EN ISO 3630-2:2013
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SIST EN ISO 3630-2:2013
INTERNATIONAL STANDARD ISO 3630-2:2013(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

or ISO 3630-5.

This part of ISO 3630 specifies requirements for size, marking, product designation, safety considerations,

and their labelling 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 1797-1, Dentistry — Shanks for rotary instruments — Part 1: Shanks made of metals

ISO 1797-2, Dental rotary instruments — Shanks — Part 2: Shanks made of plastics
ISO 1942, Dentistry — Vocabulary
ISO 3630-1:2008
...