SIST EN ISO 3630-2:2013

SLOVENSKI STANDARD
oSIST prEN ISO 3630-2:2011
01-oktober-2011
Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO/DIS 3630-
2:2011)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO/DIS 3630-2:2011)
Wurzelkanalinstrumente - Teil 2: Erweiterer (ISO/DIS 3630-2:2011)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 2: Élargisseurs (ISO/DIS
3630-2:2011)
Ta slovenski standard je istoveten z: prEN ISO 3630-2
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
oSIST prEN ISO 3630-2:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 3630-2:2011

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oSIST prEN ISO 3630-2:2011


EUROPEAN STANDARD
DRAFT
prEN ISO 3630-2 rev
NORME EUROPÉENNE

EUROPÄISCHE NORM

May 2011
ICS 11.060.25 Will supersede EN ISO 3630-2:2000
English Version
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO/DIS
3630-2:2011)
Médecine bucco-dentaire - Instruments d'endodontie - Wurzelkanalinstrumente - Teil 2: Erweiterer (ISO/DIS 3630-
Partie 2: Élargisseurs (ISO/DIS 3630-2:2011) 2:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 55.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 3630-2 rev:2011: E
worldwide for CEN national Members.

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oSIST prEN ISO 3630-2:2011
prEN ISO 3630-2:2011 (E)
Contents Page
Foreword .3

2

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oSIST prEN ISO 3630-2:2011
prEN ISO 3630-2:2011 (E)
Foreword
This document (prEN ISO 3630-2:2011) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 3630-2:2000.
Endorsement notice
The text of ISO/DIS 3630-2:2011 has been approved by CEN as a prEN ISO 3630-2:2011 without any
modification.

3

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oSIST prEN ISO 3630-2:2011

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oSIST prEN ISO 3630-2:2011

DRAFT INTERNATIONAL STANDARD ISO/DIS 3630-2
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on Voting terminates on

2011-05-26 2011-10-26
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Dentistry — Endodontic instruments —
Part 2:
Enlargers
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 2: Élargisseurs
[Revision of second edition (ISO 3630-2:2000)]
ICS 11.060.20





ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2011

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oSIST prEN ISO 3630-2:2011
ISO/DIS 3630-2

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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 copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2011 – All rights reserved

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oSIST prEN ISO 3630-2:2011
ISO/DIS 3630-2
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 General.2
4.2 Enlarger Type G.2
4.3 Enlarger Type P.2
4.4 Enlarger Type B1 .2
4.5 Enlarger Type B2 .2
4.6 Enlarger Type M.2
5 Requirements.3
5.1 Materials.3
5.1.1 Shank.3
5.1.2 Working part.3
5.2 Dimensions, designation and number of blades .3
5.2.1 General.3
5.3 Mechanical.9
5.3.1 Resistance to fracture by twisting and angular deflection .9
5.3.2 Resistance to bending .10
5.3.3 Resistance to fatigue .10
5.3.4 Fracture location.10
6 Sampling.11
7 Testing.12
7.1 General.12
7.2 Dimensions.12
7.2.1 Diameters.12
7.2.2 Tip.12
7.2.3 Shank.12
7.2.4 Length.12
7.2.5 Blades.12
7.3 Resistance to fracture by twisting and angular deflection .12
7.4 Resistance to bending .12
7.5 Resistance to fatigue .12
7.6 Fracture location.13
8 Designation, marking and identification.13
9 Packaging.13
10 Instructions for use .13
11 Labelling.14
Bibliography.15

© ISO 2011 – All rights reserved iii

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oSIST prEN ISO 3630-2:2011
ISO/DIS 3630-2
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 are 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 2011 – All rights reserved

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oSIST prEN ISO 3630-2:2011
ISO/DIS 3630-2
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 should be made to ISO 10993-1 and ISO 7405.
Attention is drawn to ISO 6360 which specifies a 15-digit number for the identification of dental rotary
instruments of all types.

© ISO 2011 – All rights reserved v

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oSIST prEN ISO 3630-2:2011

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oSIST prEN ISO 3630-2:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 3630-2

Dentistry — Endodontic instruments —
Part 2:
Enlargers
1 Scope
This part of ISO 3630 specifies sp
...