SIST EN ISO 18397:2025
(Main)Dentistry - Powered scaler (ISO 18397:2025)
Dentistry - Powered scaler (ISO 18397:2025)
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.
Zahnheilkunde - Angetriebener Scaler (ISO 18397:2025)
Dieses Dokument legt die Anforderungen und Prüfverfahren für luftangetriebene und elektrisch angetriebene Scalerhandstücke und Scalerspitzen fest, einschließlich Ultraschallscaler vom piezoelektrischen, ferrostriktiven und magnetostriktiven Typ, die als eigenständige Teile oder in Verbindung mit zahnärztlichen Behandlungseinheiten betrieben werden und zur Anwendung am Patienten dienen. Diese Internationale Norm enthält auch Festlegungen für die Gebrauchsanweisung, Kennzeichnung und Verpackung.
Médecine bucco-dentaire - Instruments pour détartrage (ISO 18397:2025)
Le présent document 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 et magnétostrictif, utilisées de manière autonome ou reliées à des units dentaires, en vue d’une utilisation sur des patients. Il contient également des spécifications relatives aux instructions du fabricant, au marquage et à l’emballage.
Zobozdravstvo - Pripomočki za čiščenje (skaler) (ISO 18397:2025)
General Information
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Standards Content (Sample)
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
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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 .
...
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