EN ISO 3630-5:2011

Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011)

This part of ISO 3630 specifies requirements and test methods for root canal instruments used for hand or mechanically operated instruments used to perform root canal procedures not cited in ISO 3630-1, 3630-2, 3630-3, or 3630-4. This document specifies requirements for size, marking, product designation, safety considerations, and their labeling and packaging, including the instructions for use.

Zahnheilkunde - Endodontische Instrumente - Teil 5: Form- und Reinigungsinstrumente (ISO 3630-5:2011)

Dieser Teil von ISO 3630 legt Anforderungen an und Prüfverfahren für von Hand oder mechanisch betätigte Form- und Reinigungsinstrumente für Wurzelkanalbehandlungen fest, die nicht in ISO 3630 1, ISO 3630 2, ISO 3630 3 oder ISO 3630 4 beschrieben werden.
Dieser Teil von ISO 3630 legt Anforderungen an Größe, Kennzeichnung, Produkt¬bezeichnung, Sicherheitsüberlegungen sowie Beschilderung und Verpackung fest.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 5: Instruments de mise en forme et de nettoyage (ISO 3630-5:2011)

L'ISO 3630-5:2011 spécifie les exigences et méthodes d'essai, non citées dans l'ISO 3630‑1, l'ISO 3630‑2, l'ISO 3630‑3, ou l'ISO 3630‑4, relatives aux instruments de mise en forme et de nettoyage, à usage manuel ou mécanique, utilisés pour effectuer des traitements sur des canaux radiculaires.
Elle spécifie les exigences relatives à la taille, au marquage, à la désignation des produits et aux considérations de sécurité, ainsi qu'à leur étiquetage et emballage.

Zobozdravstvo - Instrumenti za zobni kanal - 5. del: Instrumenti za oblikovanje in čiščenje (ISO 3630-5:2011)

Ta del ISO 3630 določa zahteve in preskusne metode za instrumente za zobni kanal, ki se uporabljajo kot ročno ali mehansko upravljani instrumenti za izvedbo posegov v zobnem kanalu in niso navedeni v ISO 3630-1, 3630-2, 3630-3 ali 3630-4. Ta dokument določa zahteve za velikost, označevanje, poimenovanje proizvodov, varnostne vidike in uporabo nalepk ter pakiranje, vključno z navodili za uporabo.

General Information

• Status: Withdrawn
• Publication Date: 30-Sep-2011
• Withdrawal Date: 15-Sep-2020
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 16-Sep-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 3630-5:2011 - Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011)

Relations

• Replaced By: EN ISO 3630-5:2020 - Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2020)
• Effective Date: 20-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2011
=RER]GUDYVWYR,QVWUXPHQWL]D]REQLNDQDOGHO,QVWUXPHQWL]DREOLNRYDQMHLQ
þLãþHQMH,62
Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630
-5:2011)
Zahnheilkunde - Wurzelkanalinstrumente - Teil 5: Form- und Reinigungsinstrumente
(ISO 3630-5:2011)
Médecine bucco-dentaire - Instruments pour canaux radiculaires - Partie 5: Instruments
de mise en forme et de nettoyage (ISO 3630-5:2011)
Ta slovenski standard je istoveten z: EN ISO 3630-5:2011
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 3630-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.060.20
English Version
Dentistry - Endodontic instruments - Part 5: Shaping and
cleaning instruments (ISO 3630-5:2011)
Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 5: Form-
Partie 5: Instruments de mise en forme et de nettoyage und Reinigungsinstrumente (ISO 3630-5:2011)
(ISO 3630-5:2011)
This European Standard was approved by CEN on 30 September 2011.

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

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. EN ISO 3630-5:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 3630-5:2011) 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 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 2012, and conflicting national standards shall be withdrawn at the
latest by April 2012.
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.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 3630-5:2011 has been approved by CEN as a EN ISO 3630-5:2011 without any modification.

INTERNATIONAL  ISO
STANDARD 3630-5
First edition
2011-10-01
Dentistry — Endodontic instruments —
Part 5:
Shaping and cleaning instruments
Médecine bucco-dentaire — Instruments d’endodontie —
Partie 5: Instruments de mise en forme et de nettoyage
Reference number
ISO 3630-5:2011(E)
©
ISO 2011
ISO 3630-5:2011(E)
COPYRIGHT PROTECTED DOCUMENT
©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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 2011 – All rights reserved

ISO 3630-5:2011(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 3630-5 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.
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
© ISO 2011 – All rights reserved    iii

ISO 3630-5:2011(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
part of ISO 3630. However, in assessing possible biological or toxicological hazards, it is recommended that
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.
iv    © ISO 2011 – All rights reserved

INTERNATIONAL STANDARD  ISO 3630-5:2011(E)
Dentistry — Endodontic instruments —
Part 5:
Shaping and cleaning instruments
1  Scope
This part of ISO 3630 specifies requirements and test methods for hand-held or mechanically operated
shaping and cleaning instruments used to perform root canal procedures not cited in ISO 3630-1, ISO 3630-2,
ISO 3630-3 or ISO 3630-4.
This part of ISO 3630 specifies requirements for size, marking, product designation, safety considerations,
labelling and packaging.
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 1942, Dentistry — Vocabulary
ISO 3630-1:2008, Dentistry — Root-canal instruments — Part 1: General requirements and test methods
3  Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 3630-1 apply.
4  Classification
For the purposes of this document, shaping and cleaning instruments are classified into five types, as specified
in ISO 3630-1:2008, Clause 4.
5  Requirements
5.1  Material
The materials used for the working part, the shank and the handle of shaping and cleaning instruments are left
to the discretion of the manufacturer but shall meet the requirements of ISO 3630-1:2008, 5.7.
5.2  Dimensions
5.2.1  General
T
...