Dentistry - Handpieces and motors (ISO 14457:2017)

ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging.
ISO 14457:2017 is applicable to the following:
a)    straight and angle handpieces;
b)    high-speed air turbine handpieces;
c)    air motors;
d)    electrical motors;
e)    prophy handpieces.
ISO 14457:2017 is not applicable to the following:
-      intraoral camera handpieces;
-      powered polymerization handpieces;
-      air-powered scalers;
-      electrical-powered scalers;
-      powder jet handpieces;
-      multifunction handpieces (syringes).
NOTE       See Annex A for clarification of handpieces and motor types covered by ISO 14457:2017.

Zahnheilkunde - Handstücke und Motoren (ISO 14457:2017)

Dieses Dokument legt Anforderungen und Prüfverfahren für Handstücke und Motoren fest, die in der Zahnheilkunde bei der Behandlung von Patienten eingesetzt und am Patienten angewendet werden, unabhängig von ihrer Konstruktion. Es legt auch Anforderungen an Herstellerangaben, Kennzeichnung und Verpackung fest.
Dieses Dokument gilt für:
a)   gerade Handstücke und Winkelstücke;
b)   schnelllaufende luftbetriebene Turbinenhandstücke;
c)   Luftmotoren;
d)   Elektromotoren;
e)   Prophylaxehandstücke.
Dieses Dokument gilt nicht für folgende:
-   Intraoralkamera-Handstücke;
-   elektrisch angetriebene Polymerisationshandstücke;
-   luftbetriebene Scaler;
-   elektrisch angetriebene Scaler;
-   Pulverstrahlhandstücke;
-   Mehrfunktions-Handstücke (Spritzen).
ANMERKUNG   Siehe Anhang A zur Klarstellung der Handstücke- und Motorentypen, die in diesem Dokument beschrieben werden.

Médecine bucco-dentaire - Pièces à main et moteurs (ISO 14457:2017)

L'ISO 14457 :2017 spécifie les exigences et les méthodes d'essai applicables aux pièces à main et aux moteurs utilisés en médecine bucco-dentaire pour le traitement de patients et en contact direct avec les patients, quelle que soit leur construction. Il spécifie également les exigences relatives aux informations du fabricant, au marquage et à l'emballage.
L'ISO 14457 :2017 est applicable:
a)    aux pièces à main droites et coudées;
b)    aux pièces à main à turbine à air comprimé à haute vitesse;
c)    aux moteurs à air;
d)    aux moteurs électriques; et
e)    aux pièces à main de prophylaxie.
L'ISO 14457 :2017 n'est pas applicable:
-      aux pièces à main à caméra intrabuccale;
-      aux pièces à main alimentées en énergie pour polymérisation;
-      aux instruments pour détartrage à air comprimé;
-      aux instruments pour détartrage électriques;
-      aux pièces à main à jet de poudre; et
-      aux pièces à main multifonctions (seringues).
NOTE       Voir l'Annexe A pour clarifier les types de pièces à main et de moteurs couverts par l'ISO 14457 :2017.

Zobozdravstvo - Ročni pripomočki in motorji (ISO 14457:2017)

Ta dokument določa zahteve in preskusne metode za ročne pripomočke in motorje, ki se uporabljajo v zobozdravstvu za zdravljenje bolnikov, pri katerih pride do neposrednega stika pripomočka z bolnikom, ne glede na njihovo zgradbo. Določa tudi zahteve za informacije proizvajalca, označevanje in pakiranje.
Ta dokument se uporablja za naslednje proizvode:
a) ravne in ukrivljene ročne pripomočke;
b) turbinske ročne pripomočke visoke hitrosti;
c) zračne motorje;
d) električne motorje;
e) zaščitne ročne pripomočke.
Ta dokument se ne uporablja za naslednje proizvode:
– intraoralne kamere;
– motorizirane polimerizacijske ročne pripomočke;
– merilne naprave na zračni pogon;
– električne merilne naprave;
– ročne pripomočke za poliranje s prašnim curkom;
– večfunkcijske ročne pripomočke (brizge).
OPOMBA: Glej dodatek A za pojasnila o vrstah ročnih pripomočkov in motorjev, ki so zajeti v tem dokumentu.

General Information

Status
Published
Publication Date
05-Dec-2017
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
06-Dec-2017
Completion Date
06-Dec-2017

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Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 14457:2018
01-februar-2018
1DGRPHãþD
SIST EN ISO 14457:2012
=RER]GUDYVWYR5RþQLSULSRPRþNLLQPRWRUML ,62
Dentistry - Handpieces and motors (ISO 14457:2017)
Zahnheilkunde - Handstücke und Motoren (ISO 14457:2017)
Médecine bucco-dentaire - Pièces à main et moteurs (ISO 14457:2017)
Ta slovenski standard je istoveten z: EN ISO 14457:2017
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 14457:2018 en

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

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SIST EN ISO 14457:2018
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SIST EN ISO 14457:2018
EN ISO 14457
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 11.060.25 Supersedes EN ISO 14457:2012
English Version
Dentistry - Handpieces and motors (ISO 14457:2017)

Médecine bucco-dentaire - Pièces à main et moteurs Zahnheilkunde - Handstücke und Motoren (ISO

(ISO 14457:2017) 14457:2017)
This European Standard was approved by CEN on 17 August 2017.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14457:2017 E

worldwide for CEN national Members.
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SIST EN ISO 14457:2018
EN ISO 14457:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 14457:2018
EN ISO 14457:2017 (E)
European foreword

This document (EN ISO 14457:2017) 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 June 2018, and conflicting national standards shall be

withdrawn at the latest by June 2018.

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 14457:2012.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 14457:2017 has been approved by CEN as EN ISO 14457:2017 without any modification.

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SIST EN ISO 14457:2018
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SIST EN ISO 14457:2018
INTERNATIONAL ISO
STANDARD 14457
Second edition
2017-10
Dentistry — Handpieces and motors
Médecine bucco-dentaire — Pièces à main et moteurs
Reference number
ISO 14457:2017(E)
ISO 2017
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SIST EN ISO 14457:2018
ISO 14457:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 14457:2018
ISO 14457:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................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 ....................................................................................................................................................................................................... 5

5.4 Noise level ................................................................................................................................................................................................... 5

5.5 Surfaces ......................................................................................................................................................................................................... 5

5.6 Power supply ............................................................................................................................................................................................ 5

5.6.1 Electrical power supply ............................................................................................................................................. 5

5.6.2 Air supply ............................................................................................................................................................................... 5

5.6.3 Water supply ....................................................................................................................................................................... 6

5.7 Air and water pressure .................................................................................................................................................................... 6

5.8 Temperature .............................................................................................................................................................................................. 6

5.8.1 General...................................................................................................................................................................................... 6

5.8.2 Temperature rise of housing ................................................................................................................................. 7

5.8.3 Excessive temperature ................................................................................................................................................ 7

5.9 Vibrations .................................................................................................................................................................................................... 8

5.10 Resistance to reprocessing ........................................................................................................................................................... 8

5.11 Leakage and/or ingress of water ............................................................................................................................................ 8

5.12 Electromagnetic compatibility .................................................................................................................................................. 8

5.13 Operating controls ............................................................................................................................................................................... 8

5.14 Usability ........................................................................................................................................................................................................ 8

5.15 Connection and supply ..................................................................................................................................................................... 8

5.15.1 General...................................................................................................................................................................................... 8

5.15.2 Connections for high-speed air turbine handpiece and air motor connectors .......... 9

5.15.3 Connection for handpieces and motors ....................................................................................................... 9

5.16 Chuck system for shanks .............................................................................................................................................................11

5.16.1 Metallic chuck system...............................................................................................................................................11

5.16.2 Non-metallic chuck system ..................................................................................................................................11

5.17 Test mandrel ..........................................................................................................................................................................................11

5.18 Speed ............................................................................................................................................................................................................13

5.19 Eccentricity .............................................................................................................................................................................................13

5.20 Stall torque ..............................................................................................................................................................................................13

5.21 Dimensions of head and nose..................................................................................................................................................13

5.22 Output power of high-speed air turbine handpiece ............................................................................................14

5.23 Handpieces with light ....................................................................................................................................................................15

6 Sampling .....................................................................................................................................................................................................................15

7 Testing ..........................................................................................................................................................................................................................15

7.1 General test conditions .................................................................................................................................................................15

7.2 Visual inspection ................................................................................................................................................................................15

7.3 Power supply — Electrical .........................................................................................................................................................15

7.4 Power supply — Air .........................................................................................................................................................................15

7.4.1 Apparatus ............................................................................................................................................................................15

7.4.2 Procedure ............................................................................................................................................................................15

7.5 Spray air supply ...................................................................................................................................................................................16

7.5.1 Apparatus ............................................................................................................................................................................16

7.5.2 Procedure ............................................................................................................................................................................16

7.6 Water supply ..........................................................................................................................................................................................16

© ISO 2017 – All rights reserved iii
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SIST EN ISO 14457:2018
ISO 14457:2017(E)

7.6.1 Apparatus ............................................................................................................................................................................16

7.6.2 Procedure ............................................................................................................................................................................16

7.7 Air and water pressure .................................................................................................................................................................16

7.7.1 Apparatus ............................................................................................................................................................................16

7.7.2 Procedure ............................................................................................................................................................................17

7.8 Motor cooling air ................................................................................................................................................................................17

7.8.1 Apparatus ............................................................................................................................................................................17

7.8.2 Procedure ............................................................................................................................................................................17

7.9 Handpiece cooling air ....................................................................................................................................................................17

7.9.1 Apparatus ............................................................................................................................................................................17

7.9.2 Procedure ............................................................................................................................................................................18

7.10 Connection for handpieces and motors ..........................................................................................................................19

7.11 Connection and supply ..................................................................................................................................................................19

7.11.1 Apparatus ............................................................................................................................................................................19

7.11.2 Procedure ............................................................................................................................................................................19

7.12 Test mandrels ........................................................................................................................................................................................19

7.13 Chuck for shanks ................................................................................................................................................................................19

7.13.1 Extraction test .................................................................................................................................................................19

7.13.2 Torque test .........................................................................................................................................................................19

7.14 Dimensions of head and nose..................................................................................................................................................20

7.14.1 Apparatus ............................................................................................................................................................................20

7.14.2 Procedure ............................................................................................................................................................................20

7.15 Eccentricity .............................................................................................................................................................................................20

7.15.1 Apparatus ............................................................................................................................................................................20

7.15.2 Procedure ............................................................................................................................................................................20

7.16 Stall torque ..............................................................................................................................................................................................20

7.16.1 Apparatus ............................................................................................................................................................................20

7.16.2 Procedure ............................................................................................................................................................................20

7.17 Noise level ................................................................................................................................................................................................21

7.17.1 Apparatus ............................................................................................................................................................................21

7.17.2 Test conditions................................................................................................................................................................21

7.17.3 Procedure ............................................................................................................................................................................21

7.18 Speed ............................................................................................................................................................................................................21

7.18.1 Apparatus ............................................................................................................................................................................21

7.18.2 Procedure ............................................................................................................................................................................21

7.19 Temperature rise of housing ....................................................................................................................................................21

7.19.1 Temperature rise of motors ................................................................................................................................21

7.19.2 Temperature rise for handpieces....................................................................................................................21

7.20 Excessive temperature ..................................................................................................................................................................22

7.20.1 Excessive temperature for motors.................................................................................................................22

7.20.2 Excessive temperature for handpieces .....................................................................................................22

7.21 Resistance to reprocessing ........................................................................................................................................................23

7.22 Output power of high-speed air turbine handpieces ..........................................................................................23

7.22.1 Apparatus ............................................................................................................................................................................23

7.22.2 Procedure ............................................................................................................................................................................23

7.23 Handpieces with light ....................................................................................................................................................................24

7.23.1 Apparatus ............................................................................................................................................................................24

7.23.2 Procedure ............................................................................................................................................................................24

8 Instructions for use, maintenance and service ..................................................................................................................25

9 Technical description ...................................................................................................................................................................................26

10 Marking .......................................................................................................................................................................................................................26

10.1 General ........................................................................................................................................................................................................26

10.2 Handpieces ..............................................................................................................................................................................................26

10.3 Motors..........................................................................................................................................................................................................26

11 Labelling .....................................................................................................................................................................................................................26

12 Packaging ..................................................................................................................................................................................................................27

iv © ISO 2017 – All rights reserved
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SIST EN ISO 14457:2018
ISO 14457:2017(E)

Annex A (informative) Handpiece and motor category tree .....................................................................................................28

Annex B (informative) Test report form ........................................................................................................................................................30

Bibliography .............................................................................................................................................................................................................................34

© ISO 2017 – All rights reserved v
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SIST EN ISO 14457:2018
ISO 14457:2017(E)
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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on 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 the following

URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental

instruments.

This second edition cancels and replaces the first edition (ISO 14457:2012), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— use of terms for handpieces and motors has been clarified;
— output power for high-speed air turbine handpieces has been added;
— light for handpieces has been added;
— a few technical data have been corrected;
— an example for the test report has been added i
...

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