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
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
24-Feb-2016
Completion Date
24-Feb-2016

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Standards Content (Sample)

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

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.
3

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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. Unles
...

SLOVENSKI STANDARD
oSIST prEN ISO 18397:2015
01-januar-2015
=RER]GUDYVWYR3ULSRPRþNL]DþLãþHQMH 6FDOHU  ,62',6
Dentistry - Powered scaler (ISO/DIS 18397:2014)
Zahnheilkunde - Zahnreiniger (Scaler) und dazugehörige Spitzen (ISO/DIS 18397:2014)
Médecine bucco-dentaire - Instruments pour le détartrage (ISO/DIS 18397:2014)
Ta slovenski standard je istoveten z: prEN ISO 18397 rev
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
oSIST prEN ISO 18397:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 18397:2015

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oSIST prEN ISO 18397:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18397
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2014-09-18 2015-02-18
Dentistry — Powered scaler
Médecine bucco-dentaire — Scalers
ICS: 11.060.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18397:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014

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oSIST prEN ISO 18397:2015
ISO/DIS 18397:2014(E)

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

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oSIST prEN ISO 18397:2015
ISO/DIS 18397:2014(E)

© ISO 2014 – All rights reserved iii

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oSIST prEN ISO 18397:2015
ISO/DIS 18397:2014(E)

Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification of scaler handpieces . 3
5 Requirements and performance .
...

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