SIST EN ISO 14457:2012
(Main)Dentistry - Handpieces and motors (ISO 14457:2012)
Dentistry - Handpieces and motors (ISO 14457:2012)
This International Standard 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. This International Standard is applicable to: a) straight and geared-angle handpieces, including handpiece attachments; b) high-speed air turbine handpieces; c) air motors; d) electrical motors; e) prophy handpieces. This International Standard is not applicable to: 1) intraoral camera handpieces; 2) powered polymerization handpieces; 3) air-powered scalers; 4) electrical powered scalers; 5) air-powder polishing handpieces; 6) multifunction handpieces (syringes).
Zahnheilkunde - Handstücke und Motoren (ISO 14457:2012)
Diese Internationale Norm gilt für Handstücke und Motoren, die in der Zahnheilkunde unabhängig von ihrer
Konstruktion für die Anwendung an Patienten angewandt werden. Sie legt Anforderungen, Prüfverfahren,
Herstellerangaben, Kennzeichnung und Verpackung fest.
Die vorliegende Internationale Norm gilt für:
a) gerade und abgewinkelte angetriebene Handstücke;
b) schnelllaufende luftbetriebene Turbinen-Handstücke;
c) Luftmotoren;
d) elektrische Motoren;
e) Prophylaxeaufsätze.
Die vorliegende Internationale Norm gilt nicht für:
a) Intraoralkamera-Handstücke;
b) elektrisch angetriebene Polymerisationshandstücke;
c) luftbetriebene Scaler;
d) elektrisch angetriebene Scaler;
e) luftbetriebene Polierer-Handstücke;
f) Multifunktions-Handstücke (Spritzen).
Médecine bucco-dentaire - Pièces à main et moteurs (ISO 14457:2012)
This Standard applies to handpieces and motors used in dentistry, regardless of their construction. It specifies requirements, test methods, manufacturer's information, marking and packaging.
This International Standard is applicable to:
a) Straight handpieces;
b) Angle handpieces;
c) High-speed air turbine handpieces;
d) Air-motors;
e) Electrical motors;
f) Prophy angled handpieces.
This International Standard is not applicable for:
a) Intraoral camera handpieces;
b) Powered polymerization handpieces,
c) Scaler, air powered;
d) Scaler, electrical powered;
e) Air-powder polishing handpiece.
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14457:2012
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
SIST EN ISO 14457:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14457:2012
---------------------- Page: 2 ----------------------
SIST EN ISO 14457:2012
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 14457:2012
EN ISO 14457:2012 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14457:2012
EN ISO 14457:2012 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 14457:2012
---------------------- Page: 6 ----------------------
SIST EN ISO 14457:2012
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
---------------------- Page: 7 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 14457:2012
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 2012 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 14457:2012
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 .19
12 Packaging .19
Annex A (informative) Handpiece categories .20
Bibliography .22
iv © ISO 2012 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 14457 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.
ISO 14457 cancels and replaces ISO 7785-1:1997, ISO 7785-2:1995, ISO 11498:1997 and ISO 13294:1997,
which have been technically revised.
© ISO 2012 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
Introduction
Dental handpieces and dental motors have been used in dental treatment procedures for many years.
Technical development creates handpieces and motors that are better and easier to use. The combination of
these items is very important for good performance.
This International Standard combines the content of the following four ISO standards, which have now
been withdrawn.
ISO 7785-1:1997, Dental handpieces — Part 1: High-speed air turbine handpieces
ISO 7785-2:1995, Dental handpieces — Part 2: Straight and geared angle handpieces
ISO 11498:1997, Dental handpieces — Dental low-voltage electrical motors
ISO 13294:1997, Dental handpieces — Dental air-motors
vi © ISO 2012 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 14457:2012
INTERNATIONAL STANDARD ISO 14457:2012(E)
Dentistry — Handpieces and motors
1 Scope
This International Standard 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.
This International Standard is applicable to:
a) straight and geared-angle handpieces, including handpiece attachments;
b) high-speed air turbine handpieces;
c) air motors;
d) electrical motors;
e) prophy handpieces.
This International Standard is not applicable to:
1) intraoral camera handpieces;
2) powered polymerization handpieces;
3) air-powered scalers;
4) electrical powered scalers;
5) air-powder polishing handpieces;
6) multifunction handpieces (syringes).
NOTE See Annex A for clarification of the handpieces, attachments and motor types covered by this International Standard.
2 Normative references
The following referenced documents are indispensable for the application 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 1797-1, Dentistry — Shanks for rotary instruments — Part 1: Shanks made of metals
ISO 1797-2, Dental rotary instruments — Shanks — Part 2: Shanks made of plastics
ISO 1942, Dentistry — Vocabulary
ISO 3964, Dental handpieces — Coupling dimensions
ISO 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted
vibration — Part 1: General requirements
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 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
© ISO 2012 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
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, Dental equipment — Graphical symbols
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, 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, Medical devices — 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.
3.1
air motor
motor powered by compressed air, which is supplied by a dental unit
3.2
air-powered powder jet handpiece
handpiece powered by air, designed to transfer powder to the patient
3.3
air-powered scaler
handpiece powered by air, with an oscillating working part
3.4
angle handpiece
handpiece with an angle between the input and output axes, driven by an air motor or an electrical motor or
with an internal power supply
3.5
contra-angle handpiece
angle handpiece with one or more additional angles placed so as to bring the working part of the instrument or
tool approximately into line with the main axis of the handpiece
3.6
non-metallic chuck
handpiece chuck with non-metallic material on the contact surface of the shank holding mechanism
3.7
electrical motor
motor powered by electrical energy, which is supplied by a dental unit
2 © ISO 2012 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
3.8
electrical powered scaler
handpiece powered by electrical energy, with an oscillating working part
3.9
working part
part of a fixed or interchangeable instrument connected to a handpiece
3.10
handpiece
powered handheld instrument used to operate a rotary, oscillating or reciprocating working part
3.11
handpiece attachment
extension part of a handpiece designed to hold a working part
3.12
handpiece chuck
part of the handpiece designed to securely hold the shank of a working part
3.13
high-speed air turbine handpiece
handpiece 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
3.14
intraoral camera handpiece
handpiece designed to take optical images in the oral cavity of the patient
3.15
motor
device, powered by air or electricity supplied by a dental unit, designed to transform energy into movement
3.16
polymerization handpiece
handpiece producing light that is applied directly to polymerizable dental materials in the oral cavity of a patient
3.17
prophy handpiece
angle handpiece used for dental prophylaxis, driven by an air motor or an electrical motor
3.18
rotary instrument
rotating instrument used in a high-speed air turbine handpiece or in a straight and geared-angle handpiece,
consisting of a shank and a working end used for dental procedures
3.19
reciprocating instrument
oscillating instrument used in a high-speed air turbine handpiece, or in a straight and geared-angle handpiece,
consisting of a shank and a working end used for dental procedures
3.20
straight handpiece
handpiece with the input and output axes in alignment, driven by an air motor or an electrical motor or with an
internal power supply
3.21
transmission part
small tool (rotary or reciprocating) designed to transmit energy from the shank to the working end
© ISO 2012 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
3.22
working end
distal end of a rotary or oscillating instrument intended for direct use in the oral cavity of the patient
4 Classification of handpieces
Handpieces are classified according to their gear ratio into three types as given in Table 1.
Table 1 — Gear ratios for handpieces
Type Gear ratio Resulting rotating speed Resulting torque Colour
1 >1:1 lower higher green
2 1:1 constant constant blue
3 1:>1 higher lower red
5 Requirements and performance
5.1 General
The construction of handpieces 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 62366.
If field-repairable, the handpieces 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.
5.2 Materials
Tests for biocompatibility shall be in accordance with ISO 7405 and 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 value generated by the handpiece shall not exceed 80 dB.
Test in accordance with 7.16.
NOTE This test applies to each handpiece as a system in actual use, i.e. each attachment 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.
NOTE In order to reduce glare, highly polished surfaces should be avoided.
4 © ISO 2012 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
5.6 Power supply
5.6.1 Electrical power supply
The following requirements are applicable for:
a) electrical motors;
b) handpieces, integrated with the motor;
c) prophy handpieces, integrated with the motor.
The requirements shall be specified by the manufacturer and shall comply with ISO 7494-1.
Test in accordance with 7.3.
5.6.2 Air supply
5.6.2.1 Air-powered handpiece
The following requirements are applicable for:
a) high-speed air turbine handpieces;
b) air motors;
c) handpieces, integrated with the air motor;
d) prophy handpieces, integrated with the air motor.
Air-powered handpieces shall be operated by a pressurized air supply in accordance with the manufacturer’s
instructions. The necessary flow rate shall be < 66 Nl/min in a pressure range of (300 ± 100) kPa [(3,0 ±1,0) bar].
Test in accordance with 7.4.
5.6.2.2 Motor cooling air
The following requirement is applicable for electrical motors.
If the electrical motor is equipped with an air cooling system, the maximum air flow rate should not be more
than 40 Nl/min and the pressure range should be 250 kPa to 500 kPa (2,5 bar to 5,0 bar). The electrical motor
should have an outlet connection for motor air cooling.
Test in accordance with 7.8.
5.6.2.3 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 operating area of the rotary instrument. If water and air are used
simultaneously, a cooling mist shall be created and transmitted to the cutting area of a rotary instrument. The
handpiece shall be capable of attaining an air flow rate of at least 1,5 Nl/min at 200 kPa (2,0 bar).
Motors shall be equipped, if applicable, to transmit air to a handpiece attachment. The equipment shall be
capable of attaining an air flow rate of at least 1,5 Nl/min at 200 kPa (2,0 bar).
Test in accordance with 7.5.
5.6.3 Water supply
The handpiece, if applicable, shall provide a water coolant capability to the operating area of the working part
at a flow rate of at least 50 ml/min at 250 kPa (2,5 bar).
© ISO 2012 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 14457:2012
ISO 14457:2012(E)
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 manufacturer’s maximum recommended operating pressure.
Test in accordance with 7.7.
5.8 Temperature
5.8.1 Temperature rise of housing
IEC 80601-2-60:2012, 201.11.1.1, applies.
Test in accordance with 7.18.
5.8.2 Temperature, excessive
IEC 80601-2-60:2012, 201.11.1.2.2, applies.
Test in accordance with 7.19.
5.9 Vibrations
ISO 5349-1 and ISO 5349-2 apply.
5.10 Resistance to reprocessing
All handpieces or parts of handpieces shall withstand 250 reprocessing cycles, internally and externally, as
defined by the manufacturer’s instructions, without deterioration in performance or showing signs of corrosion.
The reprocessing cycle shall include the recommended methods of cleaning, disinfection and sterilization.
If the manufacturer states a lower number of permitted reprocessing cycles, then this shall be used in place of
the 250 stated above.
Test in accordance with 7.20.
5.11 Leakage and/or ingress of water
IEC 60601-1:2005, 11.6, applies.
5.12 Electromagnetic compatibility
Test in accordance with 5.6.1.
5.13 Operating controls
The following requirements are applicable for all handpieces and motors described in this International Standard.
Operating controls shall be designed and located to minimize accidental activation. Graphical symbols for
operating
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.