Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2020)

This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series.
This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.

Zahnheilkunde - Endodontische Instrumente - Teil 5: Form- und Reinigungsinstrumente (ISO 3630-5:2020)

Dieses Dokument legt Anforderungen an und Prüfverfahren für handgehaltene oder mechanisch betätigte Instrumente fest, die zum Formen und Reinigen von Wurzelkanälen verwendet werden und die nicht in den anderen Teilen der Reihe ISO 3630 beschrieben werden.
Dieses Dokument legt Anforderungen an Größe, Markierung, Produktbezeichnung, Sicherheits-überlegungen, Kennzeichnung und Verpackung fest.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 5: Instruments de mise en forme et de nettoyage (ISO 3630-5:2020)

Le présent document spécifie les exigences et méthodes d'essai relatives aux instruments à usage manuel et mécanique utilisés pour la mise en forme et le nettoyage des canaux radiculaires, et qui ne sont pas spécifiées dans les autres parties de la série ISO 3630.
Le présent document 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 3630-5:2020)

General Information

Status
Published
Publication Date
30-Dec-2020
Withdrawal Date
30-Mar-2021
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Sep-2020
Completion Date
16-Sep-2020

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3630-5:2020
01-november-2020
Nadomešča:
SIST EN ISO 3630-5:2011

Zobozdravstvo - Instrumenti za zobni kanal - 5. del: Instrumenti za oblikovanje in

čiščenje (ISO 3630-5:2020)

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

-5:2020)

Zahnheilkunde - Endodontische Instrumente - Teil 5: Form- und Reinigungsinstrumente

(ISO 3630-5:2020)

Médecine bucco-dentaire - Instruments d'endodontie - Partie 5: Instruments de mise en

forme et de nettoyage (ISO 3630-5:2020)
Ta slovenski standard je istoveten z: EN ISO 3630-5:2020
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 3630-5:2020 en

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

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SIST EN ISO 3630-5:2020
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SIST EN ISO 3630-5:2020
EN ISO 3630-5
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-5:2011
English Version
Dentistry - Endodontic instruments - Part 5: Shaping and
cleaning instruments (ISO 3630-5:2020)

Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 5:

Partie 5: Instruments de mise en forme et de nettoyage Form- und Reinigungsinstrumente (ISO 3630-5:2020)

(ISO 3630-5:2020)
This European Standard was approved by CEN on 7 August 2020.

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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-5:2020 E

worldwide for CEN national Members.
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SIST EN ISO 3630-5:2020
EN ISO 3630-5:2020 (E)
Contents Page

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

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SIST EN ISO 3630-5:2020
EN ISO 3630-5:2020 (E)
European foreword

This document (EN ISO 3630-5:2020) 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 March 2021, and conflicting national standards shall

be withdrawn at the latest by March 2021.

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 3630-5:2011.

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 3630-5:2020 has been approved by CEN as EN ISO 3630-5:2020 without any

modification.
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SIST EN ISO 3630-5:2020
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SIST EN ISO 3630-5:2020
INTERNATIONAL ISO
STANDARD 3630-5
Second edition
2020-08
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 3630-5:2020(E)
ISO 2020
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SIST EN ISO 3630-5:2020
ISO 3630-5:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 2020 – All rights reserved
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SIST EN ISO 3630-5:2020
ISO 3630-5:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

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

4 Classification ............................................................................................................................................................................................................ 1

5 Requirements .......................................................................................................................................................................................................... 1

5.1 Material ......................................................................................................................................................................................................... 1

5.2 Dimensions ................................................................................................................................................................................................. 2

5.2.1 General...................................................................................................................................................................................... 2

5.2.2 Diameter ................................................................................................................................................................................. 2

5.2.3 Length........................................................................................................................................................................................ 2

5.3 Mechanical .................................................................................................................................................................................................. 2

5.3.1 Resistance to fracture by twisting and angular deflection .......................................................... 2

5.3.2 Stiffness .................................................................................................................................................................................... 4

5.3.3 Handle or plastics shank security ..................................................................................................................... 5

5.4 Chemical ....................................................................................................................................................................................................... 5

5.4.1 Resistance to corrosion .............................................................................................................................................. 5

5.4.2 Heat effects of sterilization ..................................................................................................................................... 5

5.5 Color-coding .............................................................................................................................................................................................. 6

6 Sampling ........................................................................................................................................................................................................................ 6

7 Measurement and test methods ........................................................................................................................................................... 6

7.1 General ........................................................................................................................................................................................................... 6

8 Resistance to reprocessing ........................................................................................................................................................................ 6

9 Designation, marking, and identification ................................................................................................................................... 6

10 Packaging ..................................................................................................................................................................................................................... 6

11 Instructions for use ........................................................................................................................................................................................... 6

12 Labelling ........................................................................................................................................................................................................................ 6

Bibliography ................................................................................................................................................................................................................................ 7

© ISO 2020 – All rights reserved iii
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SIST EN ISO 3630-5:2020
ISO 3630-5:2020(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
...

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