Dentistry - Excavators (ISO 23940:2021)

This document specifies dimensions and performance requirements for excavators used in dentistry.

Zahnheilkunde - Exkavatoren (ISO 23940:2021)

Dieses Dokument legt Maße und Leistungsanforderungen für in der Zahnheilkunde verwendete Exkavatoren fest.

Médecine bucco-dentaire - Excavateurs (ISO 23940:2021)

Zobozdravstvo - Ekskavatorji (ISO 23940:2021)

General Information

Status
Published
Public Enquiry End Date
19-Feb-2020
Publication Date
29-Jun-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jun-2021
Due Date
16-Aug-2021
Completion Date
30-Jun-2021

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Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 23940:2021
01-september-2021
Nadomešča:
SIST EN ISO 13397-4:2000
Zobozdravstvo - Ekskavatorji (ISO 23940:2021)
Dentistry - Excavators (ISO 23940:2021)
Zahnheilkunde - Exkavatoren (ISO 23940:2021)
Médecine bucco-dentaire - Excavateurs (ISO 23940:2021)
Ta slovenski standard je istoveten z: EN ISO 23940:2021
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 23940:2021 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 23940:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 23940:2021
EN ISO 23940
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2021
EUROPÄISCHE NORM
ICS 11.060.25 Supersedes EN ISO 13397-4:1997
English Version
Dentistry - Excavators (ISO 23940:2021)

Médecine bucco-dentaire - Excavateurs (ISO Zahnheilkunde - Exkavatoren (ISO 23940:2021)

23940:2021)
This European Standard was approved by CEN on 13 March 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 23940:2021 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 23940:2021
EN ISO 23940:2021 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 23940:2021
EN ISO 23940:2021 (E)
European foreword

This document (EN ISO 23940:2021) 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 November 2021, and conflicting national standards

shall be withdrawn at the latest by November 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 13397-4:1997.

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 23940:2021 has been approved by CEN as EN ISO 23940:2021 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 23940:2021
---------------------- Page: 6 ----------------------
SIST EN ISO 23940:2021
INTERNATIONAL ISO
STANDARD 23940
First edition
2021-04
Dentistry — Excavators
Médecine bucco-dentaire — Excavateurs
Reference number
ISO 23940:2021(E)
ISO 2021
---------------------- Page: 7 ----------------------
SIST EN ISO 23940:2021
ISO 23940:2021(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 23940:2021
ISO 23940:2021(E)
Contents Page

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

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

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

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

4 Symbols .......................................................................................................................................................................................................................... 2

5 Classification ............................................................................................................................................................................................................ 2

6 Requirements for excavators ................................................................................................................................................................... 2

6.1 Design and dimensions .................................................................................................................................................................... 2

6.2 Maximum overall length ................................................................................................................................................................. 9

6.3 Location of measurement points ............................................................................................................................................. 9

6.4 Material ......................................................................................................................................................................................................... 9

6.5 Vickers hardness of the working end .................................................................................................................................. 9

6.6 Surface finish ............................................................................................................................................................................................ 9

6.7 Connection between working end and handle .........................................................................................................10

6.8 Resistance to reprocessing ........................................................................................................................................................10

7 Measurement and test methods ........................................................................................................................................................10

7.1 Visual inspection ................................................................................................................................................................................10

7.2 Dimensions ..............................................................................................................................................................................................10

7.3 Resistance to reprocessing ........................................................................................................................................................10

7.4 Connection between working end and handle .........................................................................................................10

7.4.1 Tensile force test ...........................................................................................................................................................10

7.4.2 Torque test .........................................................................................................................................................................11

8 Marking and labelling ..................................................................................................................................................................................11

8.1 Marking on the instrument .......................................................................................................................................................11

8.2 Labelling on the package .............................................................................................................................................................11

8.3 Instructions for use ..........................................................................................................................................................................11

© ISO 2021 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 23940:2021
ISO 23940:2021(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.

This first edition cancels and replaces the first edition (ISO 13397-4:1997), which has

...

SLOVENSKI STANDARD
oSIST prEN ISO 23940:2020
01-februar-2020
Zobozdravstvo - Ekskavatorji (ISO/DIS 23940:2019)
Dentistry - Excavators (ISO/DIS 23940:2019)
Zahnheilkunde - Exkavatoren (ISO/DIS 23940:2019)
Médecine bucco-dentaire - Excavateurs (ISO/DIS 23940:2019)
Ta slovenski standard je istoveten z: prEN ISO 23940
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 23940:2020 en

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 23940:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23940:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23940
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-12-20 2020-03-13
Dentistry — Excavators
Médecine bucco-dentaire — Excavateurs
ICS: 11.060.25
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 23940:2019(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 23940:2020
ISO/DIS 23940:2019(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 23940:2020
ISO/DIS 23940:2019(E)
Contents Page

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

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

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

3 Terms, definitions and symbols ............................................................................................................................................................ 1

3.1 Terms and definitions ....................................................................................................................................................................... 1

3.2 Symbols and abbreviated terms............................................................................................................................................... 2

4 Classification ............................................................................................................................................................................................................ 2

5 Requirements for excavators ................................................................................................................................................................... 2

5.1 Design and dimensions .................................................................................................................................................................... 2

5.2 Maximum overall length ................................................................................................................................................................. 9

5.3 Location of measurement points ............................................................................................................................................. 9

5.4 Material ......................................................................................................................................................................................................... 9

5.5 Vickers hardness of the working end .................................................................................................................................. 9

5.6 Surface finish ............................................................................................................................................................................................ 9

5.7 Connection between working end and handle .........................................................................................................10

5.8 Resistance to reprocessing ........................................................................................................................................................10

6 Measurement and test methods ........................................................................................................................................................10

6.1 Visual inspection ................................................................................................................................................................................10

6.2 Dimensions ..............................................................................................................................................................................................10

6.3 Resistance to reprocessing ........................................................................................................................................................10

6.4 Connection between working end and handle .........................................................................................................10

6.4.1 Test under tensile force ...........................................................................................................................................10

6.4.2 Test under torque .........................................................................................................................................................11

7 Marking and labelling ..................................................................................................................................................................................11

7.1 Marking on the instrument .......................................................................................................................................................11

7.2 Labelling on the package .............................................................................................................................................................11

7.3 Instructions for use ..........................................................................................................................................................................11

© ISO 2019 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 23940:2020
ISO/DIS 23940:2019(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/TC 106, Dentistry, Subcommittee SC 4, Dental

instruments.

This second edition cancels and replaces the first edition (ISO 13397-4:1997), which has been

technically revised.
The main changes compared to the previous edition are as follows:

— publication under a separate standard number (ISO 23940) and therefore no longer as part of the

ISO 13397 standard series;
— addition of new shapes, see Figure 5 to Figure 10, and Table 3;

— test values for connection between working end and handle were reduced from 600 N to 450 N

(tensile load) and from 400 Ncm to 0,25 Nm (torque) (see 5.7);
— requirement for UDI-code has been added in Clause 7;
— requirement for instructions for use has been added in 7.3.

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 23940:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 23940:2019(E)
Dentistry — Excavators
1 Scope

This document specifies dimensions and performance requirements for excavators used in dentistry.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 6508-
...

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