EN ISO 14457:2017
(Main)Dentistry - Handpieces and motors (ISO 14457:2017)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 14457:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
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
...
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