EN ISO 18397:2016

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
• Withdrawal Date: 30-Aug-2016
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 24-Feb-2016
• Completion Date: 24-Feb-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 18397:2016 - Dentistry - Powered scaler (ISO 18397:2016)

Relations

• Replaces: EN ISO 15606:1999 - Dental handpieces - Air-powered scalers and scaler tips (ISO 15606:1999)
• Effective Date: 02-Mar-2016
• Replaces: EN ISO 22374:2005 - Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO 22374:2005)
• Effective Date: 17-Oct-2012
• Revised: prEN ISO 18397 - Dentistry - Powered scaler (ISO/DIS 18397:2024)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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.
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
ISO 18397:2016(E)
© 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
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ii © ISO 2016 – All rights reserved

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 .
...