SIST EN ISO 7711-1:2022
(Main)Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-1:2021)
This document specifies the general requirements and test methods for diamond rotary instruments
used in dentistry, including designation, colour code and grit sizes and a quality control for these
instruments.
It applies to all types of diamond rotary instruments independent of type and shape with exception to
diamond discs, which are specified in ISO 7711-2.
Zahnheilkunde - Rotierende Diamantinstrumente - Teil 1: Allgemeine Anforderungen (ISO 7711-1:2021)
In diesem Dokument werden allgemeine Anforderungen und Prüfverfahren für in der Zahnheilkunde
verwendete rotierende Diamantinstrumente festgelegt, darunter Bezeichnung, Farbkennzeichnung und
Korngröße und eine Qualitätskontrolle für diese Instrumente.
Es gilt für alle Arten von rotierenden Diamantinstrumenten, unabhängig von Typ und Form, mit Ausnahme
von Diamantscheiben, die in ISO 7711‐2 beschrieben werden.
Médecine bucco-dentaire - Instruments rotatifs diamantés - Partie 1: Exigences générales (ISO 7711-1:2021)
Le présent document spécifie les exigences générales et les méthodes d’essai relatives aux instruments rotatifs diamantés utilisés en médecine bucco-dentaire, y compris la désignation, le code de couleur et les tailles des grains, ainsi qu’un contrôle de qualité relatif à ces instruments.
Il s’applique à tous les types d’instruments rotatifs diamantés, quels que soient leur type et leur forme, à l’exception des disques diamantés qui sont spécifiés dans l’ISO 7711-2.
Zobozdravstvo - Dentalni diamantni instrumenti - 1. del: Splošne zahteve (ISO 7711-1:2021)
Ta dokument določa splošne zahteve in preskusne metode za dentalne diamantne instrumente, ki se uporabljajo v zobozdravstvu, vključno z oznako, barvno kodo in velikostmi ugriza ter nadzorom kakovosti za te instrumente. Uporablja se za vse vrste diamantnih rotacijskih instrumentov ne glede na vrsto in obliko, razen za diamantne diske, ki so obravnavani v standardu ISO 7711-2.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7711-1:2022
01-januar-2022
Nadomešča:
SIST EN ISO 7711-1:2000
SIST EN ISO 7711-1:2000/A1:2009
SIST EN ISO 7711-3:2005
Zobozdravstvo - Dentalni diamantni instrumenti - 1. del: Splošne zahteve (ISO
7711-1:2021)
Dentistry - Diamond rotary instruments - Part 1: General requirements (ISO 7711-
1:2021)
Zahnheilkunde - Rotierende Diamantinstrumente - Teil 1: Allgemeine Anforderungen
(ISO 7711-1:2021)
Médecine bucco-dentaire - Instruments rotatifs diamantés - Partie 1: Exigences
générales (ISO 7711-1:2021)
Ta slovenski standard je istoveten z: EN ISO 7711-1:2021
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 7711-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7711-1:2022
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SIST EN ISO 7711-1:2022
EN ISO 7711-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2021
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 7711-1:1998, EN ISO 7711-3:2004,
EN ISO 7711-1:1998/A1:2009
English Version
Dentistry - Diamond rotary instruments - Part 1: General
requirements (ISO 7711-1:2021)
Médecine bucco-dentaire - Instruments rotatifs Zahnheilkunde - Rotierende Diamantinstrumente - Teil
diamantés - Partie 1: Exigences générales (ISO 7711- 1: Allgemeine Anforderungen (ISO 7711-1:2021)
1:2021)
This European Standard was approved by CEN on 18 October 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 7711-1:2021 E
worldwide for CEN national Members.
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SIST EN ISO 7711-1:2022
EN ISO 7711-1:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 7711-1:2022
EN ISO 7711-1:2021 (E)
European foreword
This document (EN ISO 7711-1:2021) 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 May 2022, and conflicting national standards shall be
withdrawn at the latest by May 2022.
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 7711-1:1998, EN ISO 7711-3:2004 and EN ISO 7711-
1:1998/A1:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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 7711-1:2021 has been approved by CEN as EN ISO 7711-1:2021 without any
modification.
3
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SIST EN ISO 7711-1:2022
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SIST EN ISO 7711-1:2022
INTERNATIONAL ISO
STANDARD 7711-1
Second edition
2021-11
Dentistry — Diamond rotary
instruments —
Part 1:
General requirements
Médecine bucco-dentaire — Instruments rotatifs diamantés —
Partie 1: Exigences générales
Reference number
ISO 7711-1:2021(E)
© ISO 2021
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SIST EN ISO 7711-1:2022
ISO 7711-1:2021(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
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SIST EN ISO 7711-1:2022
ISO 7711-1:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 3
5 Requirements . 3
5.1 Material . 3
5.1.1 Blank . 3
5.1.2 Shank hardness . 3
5.1.3 Working part . 3
5.2 Designation, colour code, grit sizes . 3
5.2.1 Designation . 3
5.2.2 Colour code . 3
5.2.3 Grit size distribution . 4
5.2.4 Grit sizes . 4
5.3 Dimensions . 4
5.3.1 Designated dimensions of overall length . 4
5.3.2 Designated dimensions of the shank . 6
5.3.3 Dimensions of working part . 6
5.4 Bending test to verify the instrument strength . 7
5.4.1 General . 7
5.4.2 Effect on run-out . 7
5.4.3 Breaking test . 7
5.5 Resistance to processing and reprocessing . 8
6 Measurement and test methods .8
6.1 Sampling . 8
6.2 Testing of the dimensions . 8
6.3 Testing of the run-out . 9
6.4 Testing of resistance to processing and reprocessing . 9
6.4.1 Sampling . 9
6.4.2 Equipment . 9
6.4.3 Reagent . 9
6.4.4 Preparation of the test piece . 9
6.4.5 Procedure . 9
6.5 Visual inspection . 9
7 Marking and packaging .10
7.1 Marking on diamond rotary instruments . 10
7.2 Labelling on the package . 10
8 Instructions for use, processing and reprocessing .10
Bibliography .11
iii
© ISO 2021 – All rights reserved
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SIST EN ISO 7711-1:2022
ISO 7711-1:2021(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 second edition of ISO 7711-1 cancels and replaces ISO 7711-1:1997 and ISO 7711-3:2004, which
have been technically revised. It also incorporates the Amendment ISO 7711-1:1997/Amd.1:2009.
The main changes compared to the previous edition are as follows:
— the entire content of ISO 7711-3 has been included;
— definitions have been added to Clause 3;
— blank materials have been added in 5.1;
— tables for force values were removed;
— figures and tables describing bur shapes and dimensions have been removed.
A list of all parts in the ISO 7711 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 2021 – All rights reserved
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SIST EN ISO 7711-1:2022
INTERNATIONAL STANDARD ISO 7711-1:2021(E)
Dentistry — Diamond rotary instruments —
Part 1:
General requirements
1 Scope
This document specifies the general requirements and test methods for diamond rotary instruments
used in dentistry, including designation, colour code and grit sizes and a quality control for these
instruments.
It applies to all types of diamond rotary instruments independent of type and shape with exception to
diamond discs, which are specified in ISO 7711-2.
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 1797:2017, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
ISO 2157, Dentistry — Nominal diameters and designation code numbers for rotary instruments
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8325:2004, Dentistry — Test methods for rotary instruments
ISO 6106, Abrasive products — Checking the grain size of superabrasives
ISO 14457, Dentistry — Handpieces and motors
ISO 21850-1, Dentistry — Materials for dental instruments — Part 1: Stainless steel
3 Terms and definitions
For the purposes of this document, the following terms
...
SLOVENSKI STANDARD
oSIST prEN ISO 7711-1:2020
01-september-2020
Zobozdravstvo - Dentalni diamantni instrumenti - 1. del: Splošne zahteve (ISO/DIS
7711-1:2020)
Dentistry - Dental diamond instruments - Part 1: General requirements (ISO/DIS 7711-
1:2020)
Zahnheilkunde - Zahnärztliche Diamantinstrumente - Teil 1: Allgemeine Anforderungen
(ISO/DIS 7711-1:2020)
Instruments rotatifs dentaires -- Instruments diamantés -- Partie 1: Dimensions,
exigences, marquage et emballage (ISO/DIS 7711-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 7711-1
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 7711-1:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 7711-1:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 7711-1:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7711-1
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-05-14 2020-08-06
Dentistry — Diamond rotary instruments —
Part 1:
General requirements
Instruments rotatifs dentaires — Instruments diamantés —
Partie 1: Dimensions, exigences, marquage et emballage
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 7711-1:2020(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 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 7711-1:2020
ISO/DIS 7711-1:2020(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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 7711-1:2020
ISO/DIS 7711-1:2020(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 Requirements . 3
4.1 Material . 3
4.1.1 Blank . . 3
4.1.2 Shank hardness . 3
4.1.3 Working part . 3
4.2 Designation, colour code, grit sizes . 3
4.2.1 Designation . 3
4.2.2 Colour code . 3
4.2.3 Grain size distribution . 3
4.2.4 Grit sizes . 4
4.3 Dimensions . 4
4.3.1 Designated dimensions of overall length . 4
4.3.2 Designated dimensions of the shank . 5
4.3.3 Dimensions of working part . 5
4.4 Bending test to verify the instrument strength . 6
4.4.1 Effect on run-out . 6
4.4.2 Breaking test. 7
4.5 Resistance to reprocessing . 8
5 Measurement and test methods . 8
5.1 Sampling . 8
5.2 Testing of the dimensions . 8
5.3 Testing of the run-out . 8
5.4 Testing of resistance to reprocessing . 8
5.4.1 Sampling. 8
5.4.2 Equipment . 8
5.4.3 Reagent . . 9
5.4.4 Preparation of the test piece . 9
5.4.5 Procedure . 9
5.5 Visual inspection . 9
6 Marking and packaging . 9
6.1 Marking on diamond rotary instruments . 9
6.2 Labelling on the package . 9
6.3 Instructions for use and reprocessing . 9
Bibliography .10
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 7711-1:2020
ISO/DIS 7711-1:2020(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 (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 third edition of ISO 7711-1 cancels and replaces the second edition (ISO 7711:1997) and the second
edition (ISO 7711-3:2004), which has been technically revised.
The main changes compared to the previous edition are as follows:
a) inclusion of ISO 7711-3 in 7711-1;
b) addition of definitions in clause 3;
b) addition of blank materials in 4.1;
d) Tables for force values were removed (43 pages).
A list of all parts in the ISO 7711 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 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 7711-1:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 7711-1:2020(E)
Dentistry — Diamond rotary instruments —
Part 1:
General requirements
1 Scope
This document specifies general requirements and test methods for diamond rotary instruments used
in dentistry, including designation, colour code and grit sizes and a quality control for these instruments.
It applies to all types of diamond rotary instruments independent of type and shape with exception to
diamond discs which are defined in ISO 7711-2.
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 1797:2017, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry —Vocabulary
ISO 2157, Dentistry — Nominal diameters and designation code numbers for rotary instruments
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8325:2004, Dentistry — Test methods for rotary instruments
ISO 6106, Abrasive products — Checking the grain size of superabrasives
ISO 14457, Dentistry — Handpieces and motors
ISO 21850-1, Dentistry — Materials for dental instruments —Part 1: Stainless steel
3 Terms, definitions and symbols
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions given in ISO 1942 and ISO 14457
and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1.1
blank
supporting material for a rotary instrument consisting of a shank, neck (optional) and an uncoated
working part (see Figure 1)
© ISO 2020 – All rights reserved 1
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oSIST prEN ISO 7711-1:2020
ISO/DIS 7711-1:2020(E)
Key
1 working part
2 neck
3 shank
Figure 1 — Blank
3.1.2
diamond rotary instrument
rotary instrument consisting of a blank (3.1.1) and a working part (3.1.6) coated with diamond grit (see
Figure 2)
Key
1 working part
2 neck
3 shank
Figure 2 — Diamond rotary instrument
3.1.3
macrogrit
grit with grain size distribution which is determined by sieving
3.1.4
microgrit
grit with grain size distribution which is determined by sedimentation
3.1.5
shank
part of the diamond instrument to be connected to a dental handpiece
3.1.6
working part
part of the diamond instrument with an active grinding surface
3.2 Symbols and abbreviated terms
The following symbols and abbreviated terms are used in this document:
d , d , d diameter of working part; head diameter;
1 2 3
...
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