EN 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

• Status: Published
• Publication Date: 05-Dec-2017
• Withdrawal Date: 29-Jun-2018
• 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: 06-Dec-2017
• 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 14457:2018 - Dentistry - Handpieces and motors (ISO 14457:2017)

Relations

• Replaces: EN ISO 14457:2012 - Dentistry - Handpieces and motors (ISO 14457:2012)
• Effective Date: 30-Jul-2014

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
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. [phone]
Fax [phone]
[e-mail]
www.iso.org
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 supply .16
7.5.1 Apparatus .16
7.5.2 Procedure .16
7.6 Water supply .16
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

ISO 14457:2017(E)
Annex A (informative) Handpiece and motor category tree .28
Annex B (informative) Test report form .30
Bibliography .34
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 in Annex B.
vi © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 14457:2017(E)
Dentistry — Handpieces and motors
1 Scope
This document 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.
This document 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.
This document 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 this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1797, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
tolerance indications
ISO 2768-2, General tolerances — Part 2: Geometrical tolerances for features without individual tolerance
indications
ISO 3964, Dentistry — Coupling dimensions for handpiece connectors
ISO 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted
vibration — Part 1: General requirements
ISO 14457:2017(E)
ISO 5349-2, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted
vibration — Part 2: Practical guidance for measurement at the workplace
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7494-1, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 13295, Dentistry — Mandrels for rotary instruments
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 21531, Dentistry — Graphical symbols for dental instruments
IEC 60601-1:2005+AMD1:2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 80601-2-60:2012, Medical electrical equipment — Part 2-60: Particular requirements for basic safety
and essential performance of dental equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
air motor
motor (3.14) powered by compressed air, which is supplied by a dental unit
3.2
powder jet handpiece
handpiece (3.10) powered by compressed air, designed to deliver powder to the patient’s oral cavity at
high velocity
3.3
air-powered scaler
handpiece (3.10) powered by compressed air, with an oscillating working part
3.4
angle handpiece
handpiece (3.10) with an angle between the input and output axes, driven by an air motor (3.1) or an
electrical motor (3.7) or with an internal power supply, including extension part of a handpiece designed
to hold a working part (3.9)
2 © ISO 2017 – All rights reserved

ISO 14457:2017(E)
3.5
contra-angle handpiece
angle handpiece (3.4) with one or more additional angles placed so as to bring the working part (3.9) of
the instrument or tool approximately into line with the main axis of the handpiece (3.10)
3.6
non-metallic chuck
handpiece (3.10) chuck with non-metallic material on the contact surface of the shank holding
mechanism
3.7
electrical motor
motor (3.14) powered by electrical energy, which is supplied by a dental unit
3.8
electrical-powered scaler
handpiece (3.10) powered by electrical energy, with an oscillating working part
3.9
working part
part of a fixed or interchangeable instrument connected to a dental handpiece
3.10
handpiece
powered handheld instrument used to operate a rotary, oscillating or reciprocating working part (3.9)
3.11
handpiece chuck
part of the handpiece (3.10) designed to securely hold the shank of a working part (3.9)
3.12
high-speed air turbine handpiece
handpiece (3.10) propelled by a small air-powered turbine (or rotor), capable of high speed, which is
integrated into the head of the handpiece and has a chucking device coaxial with the turbine
3.13
intraoral camera handpiece
handpiece (3.10) designed to take optical images from the oral cavity of the patient
3.14
motor
device, powered by air or electricity supplied by a dental unit, designed to transform energy into
movement
3.15
multifunction handpiece
syringe
handpiece (3.10), which is supplied with air and water, and transfers the water and air directly or as air-
water mixture (spray) in a cold or warm state in the patient’s mouth
3.16
polymerization handpiece
handpiece (3.10) producing light that is applied directly in the oral cavity of a patient, mainly to
polymerize dental materials
3.17
prophy handpiece
angle handpiece (3.4) used for dental prophylaxis, driven by an air motor (3.1) or an electrical motor (3.7)
ISO 14457:2017(E)
3.18
rotary instrument
rotating instrument used for dental procedures in a high-speed air turbine handpiece (3.12), a straight or
a geared-angle handpiece, consisting of a shank and a working end (3.21)
3.19
reciprocating instrument
oscillating instrument used in a straight or geared-angle handpiece, consisting of a shank and a working
end (3.21) used for dental procedures
3.20
straight handpiece
handpiece (3.10) with the input axe and the output axe are colinear, driven by an air motor (3.1) or an
electrical motor (3.7) or with an internal power supply, including extension part of a handpiece designed
to hold a working part (3.9)
3.21
working end
distal end of a rotary, oscillating or reciprocating instrument (3.19) intended for direct use in the oral
cavity of the patient
4 Classification of handpieces
Handpieces are classified according to their gear ratio into four types as given in Table 1.
This classification applies only to handpieces for rotary and reciprocating instruments.
Table 1 — Classification for handpieces
Class Gear ratio Resulting speed Resulting torque Colour
1 >1:1 lower higher green
2 1:1 constant constant blue
3 1:>1 higher lower red
4 — Movement as given by the manufacturer yellow
NOTE  Colour marking is optional.
5 Requirements and performance
5.1 General
The construction of handpieces and motors shall provide for their safe and reliable operation. Their
use and manipulation shall be easy and comfortable for the operator. These requirements shall be
compliant with IEC 80601-2-60 and IEC 62366-1.
If field-repairable, the handpieces and motors shall be capable of being easily disassembled and
reassembled for maintenance and repair utilizing either readily available tools or special tools supplied
by the manufacturer.
Electrical requirements are only applicable to electrically powered handpieces and motors.
All pressure values given in the requirements are flow pressure values.
5.2 Materials
Materials for the handpiece and/or motor shall meet all requirements of this document. Choice of
materials shall be at the discretion of the manufacturer.
4 © ISO 2017 – All rights reserved

ISO 14457:2017(E)
Material tests for biocompatibility shall be in accordance with ISO 10993-1.
5.3 Drop test
IEC 60601-1:2005, 15.3.4.1 applies.
5.4 Noise level
The A-weighted sound pressure level generated by the handpiece and motor or by the high-speed air
turbine handpiece shall not exceed 80 dB.
Test in accordance with 7.17.
NOTE This test applies to each handpiece and motor as a system in actual use, i.e. each handpiece used with
its respective drive motor.
5.5 Surfaces
Particular attention should be given to providing secure gripping surfaces for operator manipulation
under normal conditions of use.
Test in accordance with IEC 62366-1.
In order to reduce glare, highly polished surfaces are intended to be avoided.
5.6 Power supply
5.6.1 Electrical power supply
This requirement applies to all the electric-powered handpieces and motors not only for the movement
power but also lighting or revolution speed feedback.
The requirements for electrical power supply shall be specified by the manufacturer and shall comply
with IEC 60601-1 and IEC 80601-2-60. If applicable ISO 7494-1 shall apply.
Test in accordance with 7.3.
5.6.2 Air supply
5.6.2.1 Air-powered handpieces and motors
The following requirements are applicable for:
a) high-speed air turbine handpieces;
b) air motors;
c) handpieces with integrated air motor;
d) prophy handpieces with integrated air motor.
Air-powered handpieces and motors shall be operated by a pressurized air supply in accordance
with the manufacturer’s instructions. The necessary flow rate shall be <80 NL/min at a pressure of
(300 ± 100) kPa [(3,0 ± 1,0) bar].
NOTE NL/min indicates normal litres per minute, the amount of air that flows through a pipe calculated
back to “normal” conditions (0 °C, relative humidity 0 % and 1 atm or 1,013 25 bar).
Test in accordance with 7.4.
ISO 14457:2017(E)
5.6.2.2 Motor cooling air
The following requirements are applicable for electrical motors.
If the electrical motor is equipped with an air cooling system, the maximum airflow rate taken from the
electrical motor supply hose shall be not more than 40 NL/min and the pressure range at the connector
between electrical motor and supply hose shall be 250 kPa to 500 kPa (2,5 bar to 5,0 bar). The electrical
motor shall have an outlet for motor cooling air.
Test in accordance with 7.8.
5.6.2.3 Handpiece cooling air provided by the motor
The following requirements are applicable for motors that are intended to supply handpieces with
handpiece cooling air through the motor nozzle of a coupling system according to ISO 3964.
If the motor is equipped with an air cooling system, the motor coupling system according to ISO 3964
shall be able to transmit a cooling air flow no less than 5 NL/min and no more than 40 NL/min at the
pressure recommended by the manufacturer. The recommended pressure shall be in a pressure range
of 250 kPa to 500 kPa (2,5 bar to 5,0 bar).
Test in accordance with 7.9.
5.6.2.4 Spray air supply
Spray air coolant capability may be provided at the discretion of the manufacturer. Handpieces having
spray air coolant capability shall direct air to the working end of the rotary instrument. If water and
air are used simultaneously, a cooling mist shall be created and transmitted to the working end of the
rotary instrument. If spray air functionality is separate from drive air, the handpiece shall be capable of
attaining an airflow rate of at least 1,5 NL/min at 200 kPa (2,0 bar).
The motor, if applicable, shall provide air to a handpiece at a flow rate of at least 1,5 NL/min at 250 kPa
(2,5 bar).
Test in accordance with 7.5.
5.6.3 Water supply
The handpiece, if applicable, shall provide a coolant capability to the working end of the instrument at a
flow rate of at least 50 ml/min at 200 kPa (2,0 bar).
The motor, if applicable, shall provide water to a handpiece at a flow rate of at least 50 ml/min at
250 kPa (2,5 bar).
Test in accordance with 7.6.
5.7 Air and water pressure
Applicable motors and handpieces shall remain intact, i.e. shall not rupture or burst, when subjected to
a pressure 50 % above the manufacturers maximum recommended operating pressure.
Test in accordance with 7.7.
5.8 Temperature
5.8.1 General
The following requirements are not applicable for air motors and high-speed air turbine handpieces.
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ISO 14457:2017(E)
5.8.2 Temperature rise of housing
5.8.2.1 Temperature rise for motors
IEC 80601-2-60 applies.
Test in accordance with 7.19.1.
5.8.2.2 Temperature rise for handpieces
The maximum rate of temperature rise of handpiece housing on both the operator side and the patient
side shall not exceed 5 °C per second in any condition of use. The test shall be performed in the condition
of reasonably foreseeable misuse as defined in 7.19.2.
Test in accordance with 7.19.2.
5.8.3 Excessive temperature
5.8.3.1 Excessive temperature for motors
IEC 80601-2-60 applies.
Test in accordance with 7.20.1.
5.8.3.2 Excessive temperature for handpieces
Handpieces have an operator side and a patient side.
Maximum allowable temperatures are given in Table 2. Test shall be performed in both normal
conditions and reasonably foreseeable misuse conditions.
Test in normal conditions in accordance with 7.20.2.1.
Test in reasonably foreseeable misuse conditions in accordance with 7.20.2.2.
Table 2 — Allowable maximum temperatures
Allowable maximum temperature
Conditions
°C
Glass,
Applied part
Reasonably
porcelain, Plastic,
Metal Normal foreseeable
vitreous rubber
misuse
material
Having contact with operator 56 66 71 X
Having contact with operator 65 80 80 X
Having contact with t < 1 min 51 56 60 X X
patient for a time “t”
Having contact with 1 min ≤ t < 10 min 48 48 48 X X
patient for a time “t”
Having contact with 10 min ≤ t 43 43 43 X X
patient for a time “t”
If the surface temperature of an applied part exceeds the values in Table 2, the maximum temperature
shall be disclosed in the instructions for use. The
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