Dentistry - Powered scaler (ISO 18397:2016)

ISO 18397:2016 specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.

Zahnheilkunde - Zahnreiniger (Scaler) und dazugehörige Spitzen (ISO 18397:2016)

Diese Internationale Norm legt Anforderungen und Prüfverfahren für luftangetriebene und elektrisch angetriebene Scalerhandstücke und Scalerspitzen fest, einschließlich Ultraschallscaler vom piezoelek-trischen, ferrostriktiven und magnetostriktiven Typ, die als eigenständige Teile oder in Verbindung mit zahnärztlichen Behandlungseinheiten betrieben werden und zur Anwendung am Patienten dienen. Sie enthält auch Festlegungen für die Gebrauchsanweisung, Kennzeichnung und Verpackung.

Médecine bucco-dentaire - Instruments pour le détartrage (ISO 18397:2016)

ISO 18397:2016 spécifie les exigences et les méthodes d'essai pour les pièces à main et les parties actives des instruments pour détartrage électriques et actionnés par air comprimé, notamment les instruments à ultrasons de type piézoélectrique, ferrostrictif et magnétostrictif, utilisées de manière autonome ou reliées à des units dentaires, en vue d'une utilisation sur des patients. Elle contient également des spécifications relatives aux instructions du fabricant, au marquage et à l'emballage.

Zobozdravstvo - Pripomočki za čiščenje (scaler) (ISO 18397:2016)

Ta mednarodni standard določa zahteve in preskusne metode za ročne pripomočke za čiščenje (scaler) na zračni in električni pogon ter njihove konice, vključno s piezo-, železo- in magnetostriktivnimi ultrazvočnimi pripomočki za čiščenje, ki delujejo kot samostojni pripomočki ali so priključeni na dentalne pripomočke, ki se uporabljajo za paciente. Prav tako
vsebuje tudi specifikacije za navodila proizvajalca, označevanje in pakiranje.

General Information

Status
Published
Publication Date
23-Feb-2016
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
24-Feb-2016
Completion Date
24-Feb-2016

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SLOVENSKI STANDARD
SIST EN ISO 18397:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 15606:2000
SIST EN ISO 22374:2005
=RER]GUDYVWYR3ULSRPRþNL]DþLãþHQMH VFDOHU  ,62
Dentistry - Powered scaler (ISO 18397:2016)
Zahnheilkunde - Zahnreiniger (Scaler) und dazugehörige Spitzen (ISO 18397:2016)
Médecine bucco-dentaire - Instruments pour le détartrage (ISO 18397:2016)
Ta slovenski standard je istoveten z: EN ISO 18397:2016
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 18397:2016 en

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

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SIST EN ISO 18397:2016
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SIST EN ISO 18397:2016
EN ISO 18397
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2016
EUROPÄISCHE NORM
ICS 11.060.25 Supersedes EN ISO 15606:1999, EN ISO 22374:2005
English Version
Dentistry - Powered scaler (ISO 18397:2016)

Médecine bucco-dentaire - Instruments pour le Zahnheilkunde - Zahnreiniger (Scaler) und

détartrage (ISO 18397:2016) dazugehörige Spitzen (ISO 18397:2016)
This European Standard was approved by CEN on 24 October 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18397:2016 E

worldwide for CEN national Members.
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SIST EN ISO 18397:2016
EN ISO 18397:2016 (E)
Contents Page

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

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SIST EN ISO 18397:2016
EN ISO 18397:2016 (E)
European foreword

This document (EN ISO 18397:2016) 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 August 2016, and conflicting national standards shall

be withdrawn at the latest by August 2016.
This document supersedes EN ISO 22374:2005, EN ISO 15606:1999.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.

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, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 18397:2016 has been approved by CEN as EN ISO 18397:2016 without any modification.

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SIST EN ISO 18397:2016
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SIST EN ISO 18397:2016
INTERNATIONAL ISO
STANDARD 18397
First edition
2016-01-15
Dentistry — Powered scaler
Médecine bucco-dentaire — Instruments pour le détartrage
Reference number
ISO 18397:2016(E)
ISO 2016
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SIST EN ISO 18397:2016
ISO 18397:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 18397:2016
ISO 18397:2016(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Classification of scaler handpieces .................................................................................................................................................... 3

5 Requirements and performance .......................................................................................................................................................... 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Materials ....................................................................................................................................................................................................... 3

5.3 Drop test ....................................................................................................................................................................................................... 3

5.4 Noise level ................................................................................................................................................................................................... 3

5.5 Surfaces ......................................................................................................................................................................................................... 4

5.6 Electrical power supply (if applicable) .............................................................................................................................. 4

5.7 Energy for light source (if applicable) ................................................................................................................................ 4

5.8 Air supply ..................................................................................................................................................................................................... 4

5.9 Supply of cooling liquid ................................................................................................................................................................... 4

5.10 Air and water pressure .................................................................................................................................................................... 4

5.11 Temperature .............................................................................................................................................................................................. 4

5.11.1 Temperature rise of housing ................................................................................................................................. 4

5.11.2 Temperature, excessive .............................................................................................................................................. 5

5.12 Vibrations .................................................................................................................................................................................................... 5

5.13 Resistance to reprocessing ........................................................................................................................................................... 5

5.14 Leakage and/or ingress of water ............................................................................................................................................ 5

5.15 Electromagnetic compatibility .................................................................................................................................................. 5

5.16 Operating controls ............................................................................................................................................................................... 5

5.17 Usability ........................................................................................................................................................................................................ 5

5.18 Connection .................................................................................................................................................................................................. 6

5.18.1 General...................................................................................................................................................................................... 6

5.18.2 Connections for air-powered scaler handpieces .................................................................................. 6

5.18.3 Connector for electrical-powered scaler handpieces ....................................................................... 6

5.19 Scaler tip performance ..................................................................................................................................................................... 6

5.19.1 Scaler tip connection .................................................................................................................................................... 6

5.19.2 Extraction force (for non-screw tips only) ................................................................................................ 6

5.19.3 Holding torque (for screw-in-tips only) ...................................................................................................... 6

5.19.4 Insertion force (for non-screw-tips only) .................. ................................................................................. 7

5.19.5 Tightening torque (for screw-in-tips only) ............................................................................................... 7

5.19.6 Stall effort ............................................................................................................................................................................... 7

5.19.7 Power output, scaler tips .......................................................................................................................................... 7

5.19.8 Breakage resistance ...................................................................................................................................................... 7

5.20 Frequency .................................................................................................................................................................................................... 7

5.21 Amplitude .................................................................................................................................................................................................... 7

6 Sampling ........................................................................................................................................................................................................................ 7

7 Testing ............................................................................................................................................................................................................................. 8

7.1 General test conditions .................................................................................................................................................................... 8

7.2 Visual inspection ................................................................................................................................................................................... 8

7.3 Power supply — Electrical ............................................................................................................................................................ 8

7.4 Air supply ..................................................................................................................................................................................................... 8

7.4.1 Apparatus ............................................................................................................................................................................... 8

7.4.2 Procedure ............................................................................................................................................................................... 8

7.5 Supply of cooling liquid ................................................................................................................................................................... 8

7.5.1 Apparatus ............................................................................................................................................................................... 8

7.5.2 Procedure ............................................................................................................................................................................... 8

© ISO 2016 – All rights reserved iii
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SIST EN ISO 18397:2016
ISO 18397:2016(E)

7.6 Air and water pressure .................................................................................................................................................................... 8

7.6.1 Apparatus ............................................................................................................................................................................... 8

7.6.2 Procedure ............................................................................................................................................................................... 8

7.7 Measuring device for dimensions ........................................................................................................................................... 9

7.8 Scaler tips .................................................................................................................................................................................................... 9

7.8.1 Extraction force (for non-screw-tips only)................................................................................................ 9

7.8.2 Holding torque (for screw-in-tips only) ...................................................................................................... 9

7.8.3 Insertion force (for non-screw-tips only) .................. ................................................................................. 9

7.8.4 Tightening torque (for screw-in-tips only) ............................................................................................... 9

7.8.5 Stall effort ............................................................................................................................................................................10

7.8.6 Power output, scaler tips .......................................................................................................................................10

7.8.7 Breakage resistance ...................................................................................................................................................12

7.9 Frequency .................................................................................................................................................................................................12

7.9.1 Apparatus ............................................................................................................................................................................12

7.9.2 Procedure ............................................................................................................................................................................12

7.10 Amplitude .................................................................................................................................................................................................12

7.10.1 Apparatus ............................................................................................................................................................................12

7.10.2 Procedure ............................................................................................................................................................................13

7.11 Noise level ................................................................................................................................................................................................13

7.11.1 Apparatus ............................................................................................................................................................................13

7.11.2 Test conditions................................................................................................................................................................14

7.11.3 Procedure ............................................................................................................................................................................14

7.12 Temperature rise of housing ....................................................................................................................................................14

7.13 Temperature, excessive .................................................................................................................................................................14

7.14 Resistance to reprocessing ........................................................................................................................................................14

8 Instructions for use, maintenance and service ..................................................................................................................14

9 Technical description ...................................................................................................................................................................................15

10 Marking .......................................................................................................................................................................................................................15

10.1 General ........................................................................................................................................................................................................15

10.2 Scaler handpieces ..............................................................................................................................................................................15

10.3 Scaler tips .................................................................................................................................................................................................16

11 Labelling .....................................................................................................................................................................................................................16

12 Packaging ..................................................................................................................................................................................................................16

Annex A (informative) Calculation example for power output ..............................................................................................17

iv © ISO 2016 – All rights reserved
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SIST EN ISO 18397:2016
ISO 18397:2016(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 meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental

instruments.

This first edition of ISO 18397 cancels and replaces ISO 15606:1999 and ISO 22374:2005, which have

been technically revised.
© ISO 2016 – All rights reserved v
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SIST EN ISO 18397:2016
ISO 18397:2016(E)
Introduction

Dental scaler handpieces and scaler tips have been used in dental treatment procedures for many years.

As technical development has resulted in improved scaler handpieces and tips, this revised International

Standard is necessary to ensure the level of safety and performance, both of the individual devices and

in combination, is at an appropriate level.
vi © ISO 2016 – All rights reserved
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SIST EN ISO 18397:2016
INTERNATIONAL STANDARD ISO 18397:2016(E)
Dentistry — Powered scaler
1 Scope

This International Standard specifies requirements and test methods for air-powered and electrical-

powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type

ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It

also contains specifications on manufacturers’ instructions, marking 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 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted

vibration — Part 1: General requirements

ISO 5349-2, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted

vibration — Part 2: Practical guidance for measurement at the workplace

ISO 7494-1, Dentistry — Dental units — Part 1: General requirements and test methods

ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 9687, Dental equipment — Graphical symbols for dental equipment

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process
ISO 14457, Dentistry — Handpieces and motors

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the

processing of resterilizable medical devices
ISO 21531, Graphical symbols for dental instruments

IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and

essential performance

IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential

performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests

IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications

IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

IEC 80601-2-60:2012, Medical electrical equipment — Part 2-60: Particular requirements for basic safety

and essential performance of dental equipment
© ISO 2016 – All rights reserved 1
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SIST EN ISO 18397:2016
ISO 18397:2016(E)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942, ISO 14457 and the

following apply.
3.1
powered scaler
scaler powered by air or electrical energy
3.2
air-powered scaler
handpiece powered by pressurized air, with an oscillating working part
3.3
electrical-powered scaler
handpiece powered by electrical energy, with an oscillating working part
3.4
operating area of scaler tip
area of the working part for use as described by the manufacturer
3.5
scaler handpiece

powered handheld handpiece used to operate an oscillating or reciprocating working part

3.6
scaler tip

fixed or interchangeable instrument used in an air-powered or in an electrical-powered scaler

handpiece and consisting of a shank and a working part
1 3
Key
1 working end
2 transmission part
3 shank
4 working part
Figure 1 — Designation of parts for scaler tips
3.7
transmission part
tool designed to transmit energy from the shank to the working end
Note 1 to entry: See Figure 1.
3.8
working end

distal end of an oscillating instrument intended for direct use in the oral cavity of the patient

Note 1 to entry: See Figure 1.
2 © ISO 2016 – All rights reserved
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SIST EN ISO 18397:2016
ISO 18397:2016(E)
3.9
working part
part of a fixed or interchangeable instrument connected to a scaler handpiece
Note 1 to entry: See Figure 1.
3.10
shank
part of an oscillating instrument connected to a scaler handpiece
Note 1 to entry: See Figure 1.
4 Classification of scaler handpieces

Scaler handpieces are classified according to the frequency of the scaler tips into two types as given in

Table 1.
Table 1 — Frequency of scaler tips
Type Energy supply Frequency
1 Air powered 4 000 Hz < frequency ≤ 40 000 Hz
2 Electrical powered 18 000 Hz < frequency ≤ 60 000 Hz
5 Requirements and performance
5.1 General

The construction of handpieces shall be safe and provide reliable operation. These requirements shall

be compliant with IEC 62366-1.
If field-re
...

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