SIST EN ISO 18397:2016

SLOVENSKI STANDARD
SIST EN ISO 18397:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 15606:2000
SIST EN ISO 22374:2005
=RER]GUDYVWYR3ULSRPRþNL]DþLãþHQMHVFDOHU,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

2

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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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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
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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.
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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
2
1 3
4
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.
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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
...