Dentistry - Endodontic instruments - Part 2: Enlargers (ISO/DIS 3630-2:2022)

Zahnheilkunde– Endodontische Instrumente– Teil2: Erweiterer (ISO/DIS 3630-2:2022)

Médecine bucco-dentaire - Instruments d'endodontie - Partie 2 : Élargisseurs (ISO/DIS 3630-2:2022)

Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO/DIS 3630-2:2022)

General Information

Status
Not Published
Technical Committee
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Due Date
12-Aug-2022
Completion Date
12-Aug-2022

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SLOVENSKI STANDARD
oSIST prEN ISO 3630-2:2022
01-marec-2022

Zobozdravstvo - Instrumenti za zobni kanal - 2. del: Razširjevalniki (ISO/DIS 3630-

2:2022)
Dentistry - Endodontic instruments - Part 2: Enlargers (ISO/DIS 3630-2:2022)

Zahnheilkunde– Endodontische Instrumente– Teil2: Erweiterer (ISO/DIS 3630-2:2022)

Médecine bucco-dentaire - Instruments d'endodontie - Partie 2 : Élargisseurs (ISO/DIS

3630-2:2022)
Ta slovenski standard je istoveten z: prEN ISO 3630-2
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 3630-2:2022 en,fr,de

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

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oSIST prEN ISO 3630-2:2022
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oSIST prEN ISO 3630-2:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3630-2
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-01-13 2022-04-07
Dentistry — Endodontic instruments —
Part 2:
Enlargers
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 2: Élargisseurs
ICS: 11.060.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 3630-2:2022(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 2022
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oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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
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Published in Switzerland
© ISO 2022 – All rights reserved
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oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(E)
Contents Page

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

Introduction .................................................................................................................................................................................................................................v

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

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

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

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

3.2 Symbols ......................................................................................................................................................................................................... 1

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

4.1 Enlarger Type B1 .................................................................................................................................................................................. 2

4.2 Enlarger Type B2 .................................................................................................................................................................................. 2

4.3 Enlarger Type G ..................................................................................................................................................................................... 2

4.4 Enlarger Type M .................................................................................................................................................................................... 2

4.5 Enlarger Type P ...................................................................................................................................................................................... 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 Materials ...................................................................................................................................................................................................... 2

5.2 Dimensions, designation and number of blades ....................................................................................................... 3

5.2.1 General ........................................................................................................................................................................................ 3

5.3 Mechanical requirements ............................................................................................................................................................. 8

5.3.1 Resistance to fracture by twisting and angular deflection ......................................................... 8

5.3.2 Resistance to bending .................................................................................................................................................... 8

5.3.3 Resistance to fatigue ........................................................................................................................................... ............ 8

5.3.4 Fracture location ................................................................................................................................................................ 8

5.4 Resistance to reprocessing .......................................................................................................................................................... 8

6 Sampling ....................................................................................................................................................................................................................... 9

7 Testing............................................................................................................................................................................................................................. 9

7.1 General ........................................................................................................................................................................................................... 9

7.2 Dimensions ................................................................................................................................................................................................ 9

7.2.1 Diameters ...................................................................... ............................................................................................................ 9

7.2.2 Tip ................................................................................................................................................................................................. 10

7.2.3 Shank ......................................................................................................................................................................................... 10

7.2.4 Lengths .................................................................................................................................................................................... 10

7.2.5 Blades ........................................................................................................................................................................................ 10

7.3 Resistance to fracture by twisting and angular deflection ......... ................................................................ 10

7.4 Resistance to bending ................................................................................................................................................................... 10

7.5 Resistance to fatigue ...................................................................................................................................................................... 10

7.6 Fracture location ............................................................................................................................................................................... 10

7.7 Report clause ........................................................................................................................................... ..............................................12

8 Label ...............................................................................................................................................................................................................................13

8.1 Marking ...................................................................................................................................................................................................... 13

8.2 Labeling ......... .................................................................................................................................. ...........................................................13

8.3 Packaging ................................................................................................................................................................................................. 13

9 Instructions for use ........................................................................................................................................... .............................................13

Bibliography .............................................................................................................................................................................................................................14

iii
© ISO 2022 – All rights reserved
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oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International

Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies

casting a vote.

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.

ISO 3630-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental

instruments, Working Group 9 Endodontic instruments.

This fourth edition cancels and replaces the third edition (ISO 3630-2:2013), which has been technically

revised.
The following changes were made:
— redefinition of the symbols
— redefinition of the test method
— harmonization with other parts of the 3630 series

ISO 3630 consists of the following parts, under the general title Dentistry — Endodontic instruments:

— Part 1: General requirements
— Part 2: Enlargers
— Part 3: Compactors: pluggers and spreaders
— Part 4: Auxiliary instruments
— Part 5: Shaping and cleaning instruments
— Part 6: Numeric coding system
— Part 7: Ultrasonic inserts
— Part 8: Accuracy of apex locator
© ISO 2022 – All rights reserved
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oSIST prEN ISO 3630-2:2022
ISO/DIS 3630-2:2022(E)
Introduction

Specific qualitative and quantitative requirements for freedom from biological hazard are not

included in this International Standard but it is recommended that, in assessing possible biological or

toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.

The nominal size (D) is not utilized in this document because of the nature of the enlargers. Therefore,

d represents the nominal size for this document only.
© ISO 2022 – All rights reserved
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oSIST prEN ISO 3630-2:2022
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oSIST prEN ISO 3630-2:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 3630-2:2022(E)
Dentistry — Endodontic instruments —
Part 2:
Enlargers
1 Scope

This part of ISO 3630 specifies requirements for enlargers not cited in ISO 3630-1, ISO 3630-3,

ISO 3630-4, ISO 3630-5, ISO 3630-6 or ISO 3630-7. This part of ISO 3630 specifies requirements for size,

marking, product designation, safety considerations, and their labeling and packaging, including the

instructions for use.
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 1797, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary

ISO 3630-1:2019, Dentistry — Endodontic instruments — Part 1: General requirements

ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer

— Part 1: General requirements
3 Terms, definitions and symbols
3.1 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the

following apply.
ISO and IEC maintain terminological data basis for use in standardi
...

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