SIST EN ISO 18397:2025

SLOVENSKI STANDARD
01-september-2025
Nadomešča:
SIST EN ISO 18397:2016
Zobozdravstvo - Pripomočki za čiščenje (skaler) (ISO 18397:2025)
Dentistry - Powered scaler (ISO 18397:2025)
Zahnheilkunde - Angetriebener Scaler (ISO 18397:2025)
Médecine bucco-dentaire - Instruments pour détartrage (ISO 18397:2025)
Ta slovenski standard je istoveten z: EN ISO 18397:2025
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18397
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2025
EUROPÄISCHE NORM
ICS 11.060.25 Supersedes EN ISO 18397:2016
English Version
Dentistry - Powered scaler (ISO 18397:2025)
Médecine bucco-dentaire - Instruments pour Zahnheilkunde - Angetriebener Scaler (ISO
détartrage (ISO 18397:2025) 18397:2025)
This European Standard was approved by CEN on 3 June 2025.

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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18397:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18397:2025) 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 January 2026, and conflicting national standards shall
be withdrawn at the latest by January 2026.
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 18397:2016.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 18397:2025 has been approved by CEN as EN ISO 18397:2025 without any modification.

International
Standard
ISO 18397
Second edition
Dentistry — Powered scalers
2025-07
Médecine bucco-dentaire — Instruments pour détartrage
Reference number
ISO 18397:2025(en) © ISO 2025
ISO 18397:2025(en)
© ISO 2025
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 18397:2025(en)
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 .4
5.4 Noise level .4
5.5 Surfaces .4
5.6 Electrical power supply .4
5.7 Energy for light source .4
5.8 Air supply .4
5.9 Supply of cooling liquid .4
5.10 Air and water pressure .4
5.11 Temperature .5
5.11.1 Temperature rise of housing .5
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 .6
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.6
5.19.3 Holding torque .6
5.19.4 Insertion force .7
5.19.5 Tightening torque .7
5.19.6 Stall effort .7
5.19.7 Output power of powered scaler .7
5.19.8 Breakage resistance .7
5.20 Frequency .7
5.21 Amplitude .7
6 Sampling . 7
7 Measurement and test method . 8
7.1 General test conditions .8
7.2 Visual inspection .8
7.3 Electrical power supply .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

iii
ISO 18397:2025(en)
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.9
7.8.2 Holding torque .9
7.8.3 Insertion force .9
7.8.4 Tightening torque .9
7.8.5 Stall effort .10
7.8.6 Output power of powered scaler .10
7.8.7 Breakage resistance . 12
7.9 Frequency . 12
7.9.1 Apparatus . 12
7.9.2 Procedure . 12
7.10 Amplitude . 13
7.10.1 Apparatus . 13
7.10.2 Procedure . 13
7.11 Noise level .14
7.11.1 Apparatus .14
7.11.2 Test conditions .14
7.11.3 Procedure .14
7.12 Rise of housing temperature .14
7.13 Excessive temperature .14
7.14 Resistance to reprocessing .14
8 Instructions for use, maintenance and service . 14
9 Technical description .15
10 Marking . .16
10.1 General .16
10.2 Scaler handpieces .16
10.3 Scaler tips .16
11 Labelling . 17
12 Packaging. 17
Annex A (informative) Calculation example for output power .18

iv
ISO 18397:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISOhad not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 cancels and replaces the first edition (ISO 18397:2016), which has been technically
revised.
The main changes are as follows:
— adaption of the part designations for the scaler tips;
— reducing the maximum frequency of the scaler tips for air-powered scaler handpieces;
— new specification on when to provide information on output power in the instructions for use;
— simplification of the description for the amplitude limit value.
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.

v
ISO 18397:2025(en)
Introduction
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 document is necessary
to ensure the level of safety and performance, both of the individual devices and in combination, is at an
appropriate level.
vi
International Standard ISO 18397:2025(en)
Dentistry — Powered scalers
1 Scope
This document specifies the requirements and test methods for air-powered and electrical-powered scaler
handpieces and scaler tips, including piezo and magnetostrictive type ultrasonic scalers, operated as stand-
alone items or connected to dental units, for use on patients. This document also contains specifications on
manufacturers’ instructions, marking and packaging.
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 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 — Stationary dental units and dental patient chairs — Part 1: General requirements
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 9687, Dentistry — 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 information to be supplied by the manufacturer — Part
1: General requirements
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 21531, Dentistry — 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, Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment

ISO 18397
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