EN ISO 14457:2012

Dentistry - Handpieces and motors (ISO 14457:2012)

ISO 14457:2012 is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturer's information, marking and packaging.
ISO 14457:2012 is applicable to:
straight and geared angle handpieces, including handpiece attachments;
high-speed air turbine handpieces;
air motors;
electrical motors;
prophy handpieces.

Zahnheilkunde - Handstücke und Motoren (ISO 14457:2012)

Diese Internationale Norm gilt für Handstücke und Motoren, die in der Zahnheilkunde am Patienten angewendet werden, unabhängig von ihrer Konstruktion. Sie legt Anforderungen, Prüfverfahren, Herstellerangaben, Kennzeichnung und Verpackung fest.
Diese Internationale Norm gilt für:
a)   gerade und abgewinkelte angetriebene Handstücke, einschließlich der Handstückaufsätze;
b)   schnelllaufende luftbetriebene Turbinen-Handstücke;
c)   Luftmotoren;
d)   elektrische Motoren;
e)   Prophylaxehandstücke.
Die vorliegende Internationale Norm gilt nicht für:
1)   Intraoralkamera-Handstücke;
2)   elektrisch angetriebene Polymerisationshandstücke;
3)   luftbetriebene Zahnsteinentferner (Scaler);
4)   elektrisch angetriebene Zahnsteinentferner (Scaler);
5)   luftbetriebene Polierer-Handstücke;
6)   Multifunktions-Handstücke (Spritzen).
ANMERKUNG   Siehe Anhang A zur Zuordnung von Handstücken, Motoren und Zubehör, die in diesem Dokument beschrieben werden.

Médecine bucco-dentaire - Pièces à main et moteurs (ISO 14457:2012)

L'ISO 14457:2012 s'applique aux pièces à main et aux moteurs utilisés en médecine bucco-dentaire pour le contact patient, quelle que soit leur construction. Elle spécifie les exigences, les méthodes d'essai, les informations du fabricant, le marquage et l'emballage.
L'ISO 14457:2012 s'applique
aux pièces à main rectilignes et à contre-angles, y compris aux raccordements de la pièce à main,
aux pièces à main à turbines à air comprimé pour grandes vitesses,
aux moteurs à air,
aux moteurs électriques, et
aux pièces de prophylaxie.

Zobozdravstvo - Ročni pripomočki in motorji (ISO 14457:2012)

Ta mednarodni standard velja za ročne pripomočke in motorje, ki se uporabljajo v zobozdravstvu za postopke, pri katerih pride do neposrednega stika pripomočka s pacientom, ne glede na njihovo zgradbo. Določa zahteve, preskusne metode, informacije o proizvajalcu, označevanje in pakiranje. Ta mednarodni standard velja za: a) ravne in ukrivljene ročne pripomočke, vključno z nastavki zanje; b) turbinske ročne pripomočke visoke hitrosti; c) motorje; d) električne motorje; e) zaščitne ročne pripomočke. Ta evropski standard ne velja za: 1) intraoralne kamere; 2) motorizirane polimerizacijske ročne pripomočke; 3) merilne naprave na zračni pogon; 4) električne merilne naprave; 5) ročne pripomočke za poliranje na zračni pogon; 6) večfunkcijske ročne pripomočke (brizgalke).

General Information

• Status: Withdrawn
• Publication Date: 14-Sep-2012
• Withdrawal Date: 05-Dec-2017
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 06-Dec-2017
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 14457:2012 - Dentistry - Handpieces and motors (ISO 14457:2012)

Relations

• Replaces: EN ISO 7785-2:1997 - Dental handpieces - Part 2: Straight and geared angle handpieces (ISO 7785-2:1995)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 11498:1999 - Dental handpieces - Dental low-voltage electrical motors (ISO 11498:1997)
• Effective Date: 31-Oct-2012
• Replaces: EN ISO 13294:1997 - Dental handpieces - Dental air-motors (ISO 13294:1997)
• Effective Date: 31-Oct-2012
• Replaces: EN ISO 7785-1:1999 - Dental handpieces - Part 1: High-speed air turbine handpieces (ISO 7785-1:1997)
• Effective Date: 31-Oct-2012
• Replaced By: EN ISO 14457:2017 - Dentistry - Handpieces and motors (ISO 14457:2017)
• Effective Date: 30-Jul-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2012
=RER]GUDYVWYR5RþQLSULSRPRþNLLQPRWRUML,62
Dentistry - Handpieces and motors (ISO 14457:2012)
Zahnheilkunde - Handstücke und Motoren (ISO 14457:2012)
Médecine bucco-dentaire - Pièces à main et moteurs (ISO 14457:2012)
Ta slovenski standard je istoveten z: EN ISO 14457:2012
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 14457
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2012
ICS 11.060.25
English Version
Dentistry - Handpieces and motors (ISO 14457:2012)
Médecine bucco-dentaire - Pièces à main et moteurs (ISO Zahnheilkunde - Handstücke und Motoren (ISO
14457:2012) 14457:2012)
This European Standard was approved by CEN on 14 September 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14457:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 14457:2012) 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 March 2013, and conflicting national standards shall be withdrawn at
the latest by March 2013.
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 organisations 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 14457:2012 has been approved by CEN as a EN ISO 14457:2012 without any modification.

INTERNATIONAL ISO
STANDARD 14457
First edition
2012-09-15
Dentistry — Handpieces and motors
Médecine bucco-dentaire — Pièces à main et moteurs
Reference number
ISO 14457:2012(E)
©
ISO 2012
ISO 14457:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 14457:2012(E)
Contents Page
Foreword . v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification of handpieces . 4
5 Requirements and performance . 4
5.1 General . 4
5.2 Materials . 4
5.3 Drop test . 4
5.4 Noise level . 4
5.5 Surfaces . 4
5.6 Power supply . 5
5.7 Air and water pressure . 6
5.8 Temperature . 6
5.9 Vibrations . 6
5.10 Resistance to reprocessing . 6
5.11 Leakage and/or ingress of water . 6
5.12 Electromagnetic compatibility . 6
5.13 Operating controls . 6
5.14 Usability . 7
5.15 Connection and supply . 7
5.16 Chuck system for shanks . 9
5.17 Test mandrel . 9
5.18 Speed . 11
5.19 Eccentricity . 11
5.20 Torque . 11
5.21 Dimensions of head and nose . 11
6 Sampling .12
7 Testing .12
7.1 General test conditions .12
7.2 Visual inspection .13
7.3 Power supply — Electrical .13
7.4 Power supply — Air .13
7.5 Spray air supply .13
7.6 Spray water supply .13
7.7 Air and water pressure .14
7.8 Motor cooling air .14
7.9 Connector for handpiece attachment and for air-powered handpiece .14
7.10 Connection and supply .14
7.11 Test mandrels .14
7.12 Chuck for shanks .15
7.13 Dimensions (of head and nose) .15
7.14 Eccentricity .16
7.15 Torque .16
7.16 Noise level .16
7.17 Speed .17
7.18 Temperature rise of housing .17
7.19 Temperature, excessive .17
7.20 Resistance to reprocessing .17
8 Instructions for use, maintenance and service .17
ISO 14457:2012(E)
9 Technical description .18
10 Marking .18
10.1 General .18
10.2 Handpieces .18
10.3 Motors .18
11 Labelling .
...