ISO/FDIS 7711-1

Dentistry -- Diamond rotary instruments

Médecine bucco-dentaire -- Instruments rotatifs diamantés

General Information

• Status: Published
• ICS: 11.060.20 - Dental equipment
• Technical Committee: ISO/TC 106/SC 4 - Dental instruments
• Drafting Committee: ISO/TC 106/SC 4/WG 1 - Rotary instruments
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 23-Jul-2021
• Completion Date: 23-Jul-2021

RELATIONS

• Revised: ISO 7711-1:1997 - Dental rotary instruments -- Diamond instruments
• Effective Date: 16-Jun-2018
• Revised: ISO 7711-3:2004 - Dentistry -- Diamond rotary instruments
• Effective Date: 16-Jun-2018
• Revised: ISO 7711-1:1997/Amd 1:2009 - ISO 7711-1:1997/Amd 1:2009
• Effective Date: 16-Jun-2018

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 7711-1
ISO/TC 106/SC 4
Dentistry — Diamond rotary
Secretariat: DIN
instruments —
Voting begins on:
2021-07-23
Part 1:
Voting terminates on:
General requirements
2021-09-17
Médecine bucco-dentaire — Instruments rotatifs diamantés —
Partie 1: Exigences générales
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 7711-1:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
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ISO/FDIS 7711-1:2021(E)
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© ISO 2021

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ii © ISO 2021 – All rights reserved
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ISO/FDIS 7711-1:2021(E)
Contents Page

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

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

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

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

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

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 Effect on run-out .............................................................................................................................................................. 7

5.4.2 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 ................................................................................................................................................................................. 9

7.1 Marking on diamond rotary instruments ........................................................................................................................ 9

7.2 Labelling on the package .............................................................................................................................................................10

7.3 Instructions for use, processing and reprocessing ...............................................................................................10

Bibliography .............................................................................................................................................................................................................................11

© ISO 2021 – All rights reserved iii
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ISO/FDIS 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 the first edition (ISO 7711:1997) and the second

edition (ISO 7711-3:2004), which have been technically revised.
The main changes compared to the previous edition are as follows:
— the references ISO 7711-3 in 7711-1 have been included;
— definitions have been added to Clause 3;
— blank materials have been added in 4.1;
— tables for force values were 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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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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, definitions and symbols

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 https:// www .electropedia .org/
3.1
blank

supporting material for a rotary instrument consisting of a shank (3.5), neck (optional) and an uncoated

working part (3.6)
Note 1 to entry: See Figure 1.
© ISO 2021 – All rights reserved 1
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ISO/FDIS 7711-1:2021(E)
Key
1 working part
2 neck
3 shank
Figure 1 — Blank
3.2
diamond rotary instrument

rotary instrument consisting of a blank (3.1) and a working part (3.6) coated with diamond grit

Note 1 to entry: See Figure 2.
Key
1 working part
2 neck
3 shank
Figure 2 — Diamond rotary instrument
3.3
macrogrit
grit with grit size distribution which is determined by sieving
3.4
microgrit
grit with grit size distribution which is determined by sedimentation
3.5
shank
part of the diamond instrument to be connected to a dental handpiece
3.6
working part
part of the diamond instrument with an active grinding surface
4 Symbols
The following symbols are used in this document:
2 © ISO 2021 – All rights reserved
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ISO/FDIS 7711-1:2021(E)
d diameter of the working part
d diameter of the head diameter;
D minimum of neck diameter
F test force for run-out
F test force for breaking test
L length from the tip to the minimum of neck diameter
L overall length of the instrument

NOTE The overall length of the instrument, L , is the sum of the fitting length of the shank, the

length of the neck and the length of the working part.
5 Requirements
5.1 Material
5.1.1 Blank

The stainless steel material for the blank of the diamond rotary instrument shall be in accordance with

ISO 21850-1.
5.1.2 Shank hardness
The hardness of the shank shall comply with ISO 1797.
5.1.3 Working part

The working part shall be coated with diamond grit, bound in either metal or other suitable material at

the discretion of the manufacturer.
The diamond grit may consist of natural or synthetic origin.
5.2 Designation, colour code, grit sizes
5.2.1 Designation

The fineness of the diamond grit used shall comply with the requirements in Table 1.

5.2.2
...