SIST EN ISO 3630-3:2021

Dentistry - Endodontic instruments - Part 3: Compactors (ISO 3630-3:2021)

This document specifies the requirements and test methods for endodontic compactors (pluggers and
spreaders) which are used for the compaction of endodontic filling materials, and also heat-carriers
(which are not specified in the other parts of the ISO 3630 series).
This document specifies the requirements for size, marking, product designation, safety considerations,
and their labelling and packaging.

Zahnheilkunde - Endodontische Instrumente - Teil 3: Verdichter (ISO 3630-3:2021)

Dieses Dokument legt die Anforderungen und Prüfverfahren für endodontische Verdichter (Stopfer und Spreizer) fest, die zum Verdichten von endodontischen Füllwerkstoffen und auch als Wärmeträger (die in den anderen Teilen der Normenreihe ISO 3630 nicht beschrieben sind) verwendet werden.
Dieses Dokument legt die Anforderungen an Größe, Kennzeichnung, Produktbezeichnung, Sicherheits-betrachtungen und ihre Kennzeichnung und Verpackung fest.

Médecine bucco-dentaire - Instruments d'endodontie - Partie 3: Compacteurs (ISO 3630-3:2021)

Le présent document spécifie les exigences et méthodes d’essai applicables aux compacteurs d’endodontie (compacteurs axiaux et compacteurs latéraux) utilisés pour compacter des produits d’obturation endodontiques, ainsi qu’aux instruments caloporteurs (qui ne sont pas spécifiés 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 - 3. del: Kompaktorji (ISO 3630-3:2021)

General Information

• Status: Published
• Public Enquiry End Date: 04-Jul-2019
• Publication Date: 22-Jul-2021
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 30-Jun-2021
• Due Date: 04-Sep-2021
• Completion Date: 23-Jul-2021
• Ref Project: EN ISO 3630-3:2021 - Dentistry - Endodontic instruments - Part 3: Compactors (ISO 3630-3:2021, Corrected version 2023-05)

Relations

• Replaces: SIST EN ISO 3630-3:2015 - Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015)
• Effective Date: 01-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3630-3:2021
01-september-2021
Nadomešča:
SIST EN ISO 3630-3:2015
Zobozdravstvo - Instrumenti za zobni kanal - 3. del: Kompaktorji (ISO 3630-3:2021)
Dentistry - Endodontic instruments - Part 3: Compactors (ISO 3630-3:2021)
Zahnheilkunde - Endodontische Instrumente - Teil 3: Verdichter (ISO 3630-3:2021)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 3: Compacteurs (ISO 3630-
3:2021)
Ta slovenski standard je istoveten z: EN ISO 3630-3:2021
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 3630-3:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3630-3:2021

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SIST EN ISO 3630-3:2021


EN ISO 3630-3
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2021
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 3630-3:2015
English Version

Dentistry - Endodontic instruments - Part 3: Compactors
(ISO 3630-3:2021)
Médecine bucco-dentaire - Instruments d'endodontie - Zahnheilkunde - Endodontische Instrumente - Teil 3:
Partie 3: Compacteurs (ISO 3630-3:2021) Verdichter (ISO 3630-3:2021)
This European Standard was approved by CEN on 19 April 2021.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-3:2021 E
worldwide for CEN national Members.

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SIST EN ISO 3630-3:2021
EN ISO 3630-3:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 3630-3:2021
EN ISO 3630-3:2021 (E)
European foreword
This document (EN ISO 3630-3:2021) 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 December 2021, and conflicting national standards
shall be withdrawn at the latest by December 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 3630-3:2015.
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 3630-3:2021 has been approved by CEN as EN ISO 3630-3:2021 without any
modification.

3

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SIST EN ISO 3630-3:2021

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SIST EN ISO 3630-3:2021
INTERNATIONAL ISO
STANDARD 3630-3
Third edition
2021-06
Dentistry — Endodontic
instruments —
Part 3:
Compactors
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 3: Compacteurs
Reference number
ISO 3630-3:2021(E)
©
ISO 2021

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SIST EN ISO 3630-3:2021
ISO 3630-3:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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SIST EN ISO 3630-3:2021
ISO 3630-3:2021(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classifications and symbols . 2
4.1 Classifications . 2
4.2 Symbols . 2
5 Requirements . 3
5.1 Material . 3
5.2 Dimensional requirements . 3
5.2.1 General. 3
5.2.2 Diameter . 3
5.2.3 Length. 3
5.2.4 Tip . 3
5.2.5 Shaft . 4
5.2.6 Binangle compactor . 5
5.3 Mechanical requirements . 6
5.3.1 Stiffness (resistance to bending), finger compactors . 6
5.3.2 Stiffness (resistance to bending), binangle compactors . 6
5.3.3 Stiffness (resistance to bending), heat-carriers . 6
5.3.4 Handle security . 7
5.3.5 Surface finish . 7
5.4 Resistance to reprocessing . 7
5.5 Colour-coding . 7
6 Sampling . 7
7 Testing . 7
7.1 General . 7
7.2 Size . 7
7.3 Stiffness (resistance to bending), finger compactors . 8
7.4 Stiffness (resistance to bending), binangle compactors . 8
7.5 Stiffness (resistance to bending), heat-carriers . 9
7.6 Handle security .10
8 Designation, marking, and identification .10
9 Packaging .10
10 Instructions for use .10
11 Labelling .10
Bibliography .11
© ISO 2021 – All rights reserved iii

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SIST EN ISO 3630-3:2021
ISO 3630-3:2021(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 third edition cancels and replaces the second edition (ISO 3630-3:2015), which has been technically
revised.
The main changes compared to the previous editions are as follows:
— the symbols D, d and d in this document have been harmonized with the other parts of the
3 16
ISO 3630 series;
— ‘types’ has been changed to ‘classes’;
— test methods have been improved.
A list of all parts in the ISO 3630 series can be found on
...

SLOVENSKI STANDARD
oSIST prEN ISO 3630-3:2019
01-julij-2019
Zobozdravstvo - Instrumenti za zobni kanal - 3. del: Kompaktorji (ISO/DIS 3630-
3:2019)
Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders
(ISO/DIS 3630-3:2019)
Zahnheilkunde - Endodontische Instrumente - Teil 3: Verdichter: Stopfer und Spreader
(ISO/DIS 3630-3:2019)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 3: Compacteurs axiaux et
latéraux (ISO/DIS 3630-3:2019)
Ta slovenski standard je istoveten z: prEN ISO 3630-3
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 3630-3:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 3630-3:2019

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oSIST prEN ISO 3630-3:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3630-3
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-04-02 2019-06-25
Dentistry — Endodontic instruments —
Part 3:
Compactors: pluggers and spreaders
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 3: Compacteurs axiaux et latéraux
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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 3630-3:2019(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 2019

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oSIST prEN ISO 3630-3:2019
ISO/DIS 3630-3:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 3630-3:2019
ISO/DIS 3630-3:2019(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Types . 2
5 Classification . 2
6 Requirements . 2
6.1 Material . 2
6.2 Dimensional requirements . 2
6.2.1 General. 2
6.2.2 Diameters . 2
6.2.3 Length. 2
6.2.4 Hand compactors . 5
6.3 Mechanical requirements . 6
6.3.1 Stiffness (resistance to bending), finger compactors . 6
6.3.2 Stiffness (resistance to bending), hand compactors . 6
6.3.3 Stiffness (resistance to bending), heat-carrier instruments . 6
6.3.4 Handle security . 6
6.3.5 Surface finish . 6
6.4 Resistance to reprocessing . 6
6.5 Color-coding . 6
7 Sampling . 6
8 Testing . 7
8.1 General . 7
8.1.1 Size . 7
8.1.2 Stiffness (resistance to bending), finger instruments . 7
8.1.3 Stiffness (resistance to bending), hand instruments . 8
8.1.4 Bending (stiffness), heat-carrier instruments . 9
9 Designation, marking, and identification . 9
10 Packaging . 9
11 Instructions for use . 9
12 Labeling . 9
Bibliography .10
© ISO 2019 – All rights reserved iii

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oSIST prEN ISO 3630-3:2019
ISO/DIS 3630-3:2019(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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/106, Dentistry, Subcommittee SC 4, Dental
instruments.
This third edition cancels and replaces the second edition (ISO 3630-3:2015), which has been technically
revised.
The main changes compared to the previous editions are as follows:
— harmonization of d , d and d with other 3630 documents.
0 3 16
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 2019 – All rights reserved

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oSIST prEN ISO 3630-3:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 3630-3:2019(E)
Dentistry — Endodontic instruments —
Part 3:
Compactors: pluggers and spreaders
1 Scope
This document specifies requirements and test methods for endodontic instruments used as pluggers
and spreaders, used to compact endodontic filling materials not cited in the other parts of the 3630 series.
This document specifies requirements for size, marking, product designation, safety considerations,
and their labeling and packaging.
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 1942, Dentistry — Vocabulary
ISO 3630-
...