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

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)

Zobozdravstvo - Instrumenti za zobni kanal - 3. del: Kompaktorji (ISO 3630-3:2021)

General Information

Status
Published
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Jun-2021
Completion Date
23-Jun-2021

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 3630-3:2021
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 3630-3:2021
EN ISO 3630-3:2021 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 3630-3:2021
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
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
---------------------- Page: 9 ----------------------
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.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 3630-3:2019
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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
---------------------- Page: 5 ----------------------
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
---------------------- Page: 6 ----------------------
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-
...

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