SIST EN ISO 22569:2020
(Main)Dentistry - Multifunction handpieces (ISO 22569:2020)
Dentistry - Multifunction handpieces (ISO 22569:2020)
This document is one of a series of standards describing the characteristics for identification cards as defined in the definitions clause and the use of such cards for international interchange.
This document specifies requirements for a high coercivity magnetic stripe (including any protective overlay) on an identification card and encoding technique. It takes into consideration both human and machine aspects and states minimum requirements.
Coercivity influences many of the quantities specified in this document but is not itself specified. The main characteristic of the high coercivity magnetic stripe is its improved resistance to erasure. This is achieved with minimal probability of damage to other magnetic stripes by contact while retaining read compatibility with magnetic stripes as defined in ISO/IEC 7811-2.
This document provides for a card capacity of approximately 10 times that of a card conforming to ISO/IEC 7811-6. The number of tracks has been increased to 6, each track being approximately half the width of tracks conforming to ISO/IEC 7811-6, located so that readers designed to read these high density tracks will also be able to read cards conforming to ISO/IEC 7811-2 and ISO/IEC 7811-6. Data is encoded in 8 bit bytes using the MFM encoding technique. Data framing is used to limit error propagation and error correction techniques further improve reliability of reading.
It is the purpose of the ISO/IEC 7811 series of standards to provide criteria to which cards shall perform. No consideration is given within these standards to the amount of use, if any, experienced by the card prior to test. Failure to conform to specified criteria is negotiated between the involved parties.
ISO/IEC 10373-2 specifies the test procedures used to check cards against the parameters specified in this document.
NOTE Numeric values in the SI and/or Imperial measurement system in this document may have been rounded off and are consistent with, but not exactly equal to each other. Using either system is correct but intermixing or reconverting values can result in errors. The original design was made using the Imperial measurement system.
Zahnheilkunde - Mehrfunktionshandstücke (ISO 22569:2020)
Dieses Dokument legt Anforderungen, Prüfverfahren, Gebrauchsanweisung und Kennzeichnung für Mehrfunktionshandstücke (umgangssprachlich als „Spritzen“ bezeichnet) fest, die in der Mundhöhle des Patienten angewendet werden.
Dieses Dokument ist nicht anwendbar für dentale Handstücke und Motoren, Intraoralkameras, dentale Polymerisationslampen, angetriebene Scaler, Pulverstrahlhandstücke, Prophylaxehandstücke, Absaug-kanülen und Speichelzieher.
Médecine bucco-dentaire - Pièces à main multifunctionale (ISO 22569:2020)
Le présent document spécifie les exigences, les méthodes d'essai, les instructions d'utilisation et le marquage des pièces à main multifonctions (familièrement appelées «seringues») destinées à être utilisées dans la cavité buccale du patient.
Le présent document ne s'applique pas aux pièces à main et moteurs dentaires, caméras intrabuccales, lampes à polymériser dentaires, détartreurs électriques, pièces à main à jet de poudre, pièces à main de prophylaxie, canules d'aspiration et aspirateurs de salive.
Zobozdravstvo - Večnamenski ročni pripomočki (ISO 22569:2020)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22569:2020
01-september-2020
Zobozdravstvo - Večnamenski ročni pripomočki (ISO 22569:2020)
Dentistry - Multifunction handpieces (ISO 22569:2020)
Zahnheilkunde - Mehrfunktionshandstücke (ISO 22569:2020)
Médecine bucco-dentaire - Pièces à main multifunctionale (ISO 22569:2020)
Ta slovenski standard je istoveten z: EN ISO 22569:2020
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 22569:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22569:2020
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SIST EN ISO 22569:2020
EN ISO 22569
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2020
EUROPÄISCHE NORM
ICS 11.060.25
English Version
Dentistry - Multifunction handpieces (ISO 22569:2020)
Médecine bucco-dentaire - Pièces à mains Zahnheilkunde - Mehrfunktionshandstücke (ISO
multifonctions (ISO 22569:2020) 22569:2020)
This European Standard was approved by CEN on 9 May 2020.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22569:2020 E
worldwide for CEN national Members.
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SIST EN ISO 22569:2020
EN ISO 22569:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 22569:2020
EN ISO 22569:2020 (E)
European foreword
This document (EN ISO 22569:2020) 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 January 2021, and conflicting national standards shall
be withdrawn at the latest by January 2021.
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.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22569:2020 has been approved by CEN as EN ISO 22569:2020 without any modification.
3
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SIST EN ISO 22569:2020
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SIST EN ISO 22569:2020
INTERNATIONAL ISO
STANDARD 22569
First edition
2020-06
Dentistry — Multifunction handpieces
Médecine bucco-dentaire — Pièces à mains multifonctions
Reference number
ISO 22569:2020(E)
©
ISO 2020
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SIST EN ISO 22569:2020
ISO 22569:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 22569:2020
ISO 22569:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Shape . 2
4.2 Number of functions . 2
4.3 Single use or reusable cannula . 3
5 Requirements . 3
5.1 General . 3
5.2 Handling. 4
5.2.1 Rotation of cannula . 4
5.2.2 Pull-off force of cannula . 4
5.3 Maintenance . 4
5.4 Materials . 4
5.5 Mechanical strength . 4
5.6 Surfaces . 4
5.7 Air supply . 4
5.8 Water supply . 5
5.9 Water outlet . 5
5.10 Air outlet. 5
5.11 Spray outlet . 5
5.12 Tightness . 5
5.13 Air and water pressure . 5
5.14 Electrical power supply . 5
5.15 Temperature . 6
5.15.1 Water temperature . 6
5.15.2 Air temperature . 6
5.15.3 Spray temperature. 6
5.15.4 Temperature rise of the housing . 6
5.15.5 Temperature, excessive . 6
5.16 Backflow prevention . 6
5.17 Reprocessing . 6
5.18 Resistance to reprocessing . 6
5.19 Operating controls . 7
5.20 Usability . 7
5.21 Connection and supply . 7
5.22 Test report . 7
6 Sampling . 7
7 Measurement and test methods . 8
7.1 General test conditions . 8
7.2 Visual inspection . 8
7.3 Spray angle . 8
7.3.1 Equipment . 8
7.3.2 Procedure . 8
7.4 Handling. 8
7.5 Air supply . 8
7.5.1 Equipment . 8
7.5.2 Procedure . 9
7.6 Water supply . 9
7.6.1 Equipment . 9
© ISO 2020 – All rights reserved iii
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SIST EN ISO 22569:2020
ISO 22569:2020(E)
7.6.2 Procedure . 9
7.7 Tightness . 9
7.8 Air and water pressure . 9
7.8.1 Equipment . 9
7.8.2 Procedure . 9
7.9 Temperature . 9
7.9.1 Water temperature . 9
7.9.2 Air temperature . 9
7.9.3 Spray temperature.10
7.10 Air outlet.10
7.11 Backflow prevention .10
7.12 Resistance to reprocessing .11
8 Instructions for use, maintenance and servicing .11
9 Technical description .12
10 Marking .12
10.1 General .12
10.2 Multifunction handpieces .13
11 Labelling .13
12 Packaging .13
Annex A (informative) Example of a test report .14
iv © ISO 2020 – All rights reserved
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SIST EN ISO 22569:2020
ISO 22569:2020(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 of 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4,
Dental instruments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST EN ISO 22569:2020
ISO 22569:2020(E)
Introduction
For many years, dental multifunction handpieces have been used in the field of dentistry to carry out
treatment in the oral cavity of the patient.
Multifunction handpieces are connected to dental units and provide the user with water, air and spray
for treatment purposes. Some multifunction handpieces provide also illumination of the situs.
Technological progress enables continual development of improved and new handpieces with simplified
handling and extended range of applications.
These handpieces are produced by the dental industry as high-quality medical devices under application
of quality management methods.
This document describes the applicable technical properties of products in order to maintain this high
level of quality.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 22569:2020
INTERNATIONAL STANDARD ISO 22569:2020(E)
Dentistry — Multifunction handpieces
1 Scope
This document specifies requirements, test methods, instructions for use and marking for multifunction
handpieces (colloquially called “syringes”) intended to be used in the oral cavity of the patient.
This document does not apply to dental handpieces and motors, intraoral cameras, dental
polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces, suction cannulas
and saliva ejectors.
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 1942, Dentistry — Vocabulary
ISO 7494-1, Dentistry — Stationary dental units and dental patient chairs — Part 1: General requirements
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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17664, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
ISO 21531, Dentistry — Graphical symbols for dental instruments
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for the 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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
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SIST EN ISO 22569:2020
ISO 22569:2020(E)
3.1
multifunction handpiece
handpiece, which is supplied with air and water and transfers the water and air directly or as air water
mixture (spray) in cold and/or warm state into the oral cavity of the patient
Note 1 to entry: Multifunction handpieces may be additionally equipped with a light function.
Note 2 to entry: Also used terms are multi-way syringe or multifunction syringe. A colloquial used term is
“syringe”.
3.2
cannula
forward, detachable part of the multifunction handpiece (3.1)
4 Classification
4.1 Shape
Multifunction handpieces are classified according to their geometry (as shown in Figure 1 to Figure 3)
as follows:
— angled handpieces;
— straight handpieces;
— curved handpieces.
4.2 Number of functions
The number of transferable fluids such as air, water and spray as well as fluid heating is indicated with
a numerical designation:
EXAMPLE 1 3-function handpiece: water, air, and spray.
EXAMPLE 2 6-function handpiece: water, air, spray, warm water, warm air, and warm spray.
In addition, the lighting equipment is also indicated if applicable.
Figure 1 — Angled multifunction handpiece
2 © ISO 2020 – All rights reserved
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SIST EN ISO 22569:2020
ISO 22569:2020(E)
Figure 2 — Straight multifunction handpiece
Figure 3 — Curved multifunction handpiece
4.3 Single use or reusable cannula
Cannula are classified by their capability to be reused as follows:
— single-use cannula;
— reusable cannula.
5 Requirements
5.1 General
The safe and reliable operation of multifunction handpieces shall be ensured by their design.
To meet this requirement, the handpiece shall be in accordance with the requirements specified in 5.2
to 5.22.
Multifunction handpieces should be suitable for continuous operation. IEC 60601-1:2005/AMD1: 2012,
6.6 applies.
All pressure values given in the requirements are flow pressure values.
© ISO 2020 – All rights reserved 3
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SIST EN ISO 22569:2020
ISO 22569:2020(E)
5.2 Handling
5.2.1 Rotation of cannula
The cannula of the multifunction handpiece used to control the discharged media shall be rotatable
through 360°.
Test in accordance with 7.4.
5.2.2 Pull-off force of cannula
The pull-off force for removing the cannula and the grip sleeve of the multifunction handpiece shall be
(30 ± 20) N.
This requirement only applies to handpieces intended for the use with dental units which conform to
ISO 7494-1, and does not apply for handpieces with a lock system (e.g. push button or screw).
Test in accordance with 7.4.
5.3 Maintenance
If the multifunction handpieces are field-repairable according to the manufacturer's indications, they
shall be easy to disassemble and reassemble for maintenance and repair. Either commonly used tools or
special tools supplied by the manufacturer shall be used for this purpose.
IEC 62366-1 shall be followed.
5.4 Materials
Materials shall meet all requirements of this document. Choice of materials shall be at the discretion of
the manufacturer.
Material tests for biocompatibility shall be in accordance with ISO 10993-1.
5.5 Mechanical strength
IEC 60601-1:2005/AMD1: 2012, 15.3.1 general shall apply.
IEC 60601-1:2005/AMD1: 2012, 15.3.2 push test shall apply.
IEC 60601-1:2005/AMD1: 2012, 15.3.3 impact test shall apply.
IEC 60601-1:2005/AMD1: 2012, 15.3.4.1 drop test, hand-held ME equipment shall apply.
IEC 60601-1:2005/AMD1: 2012, 15.3.6 mould stress relief test, if applicable, shall apply.
5.6 Surfaces
Particular attention shall be given to provide secure gripping surfaces for operator manipulation under
normal conditions of use.
Test following the process described in IEC 62
...
SLOVENSKI STANDARD
oSIST prEN ISO 22569:2019
01-julij-2019
Zobozdravstvo - Večnamenski ročni pripomočki (ISO/DIS 22569:2019)
Dentistry - Multifunction handpieces (ISO/DIS 22569:2019)
Zahnheilkunde - Mehrfunktionshandstücke (ISO/DIS 22569:2019)
Médecine bucco-dentaire - Pièces à main multifunctionale (ISO/DIS 22569:2019)
Ta slovenski standard je istoveten z: prEN ISO 22569
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 22569:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 22569:2019
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oSIST prEN ISO 22569:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22569
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-05-10 2019-08-02
Dentistry — Multifunction handpieces
Médecine bucco-dentaire — Pièces à main multifunctionale
ICS: 11.060.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 22569:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Shape . 2
4.2 Number of functions . 2
5 Requirements . 3
5.1 General . 3
5.2 Handling. 3
5.2.1 Rotation of cannula . 3
5.2.2 Pull-off force of cannula . 4
5.3 Maintenance . 4
5.4 Materials . 4
5.4.1 General. 4
5.4.2 Biocompatibility . 4
5.5 Mechanical strength . 4
5.6 Surfaces . 4
5.7 Air supply . 4
5.8 Water supply . 5
5.9 Water outlet . 5
5.10 Air outlet. 5
5.11 Spray outlet . 5
5.12 Tightness . 5
5.13 Air and water pressure . 5
5.14 Electrical power supply . 5
5.15 Temperature . 6
5.15.1 Water temperature . 6
5.15.2 Air temperature . 6
5.15.3 Spray temperature. 6
5.15.4 Temperature rise of the housing . 6
5.15.5 Temperature, excessive . 6
5.16 Backflow preventer . 6
5.17 Reprocessing . 6
5.18 Resistance to reprocessing . 6
5.19 Operating controls . 7
5.20 Usability . 7
5.21 Connection and supply . 7
5.21.1 General. 7
5.22 Test report . 7
6 Sampling . 7
7 Measurement and test methods . 7
7.1 General test conditions . 7
7.2 Visual inspection . 7
7.3 Spray angle . 8
7.3.1 Equipment . 8
7.3.2 Procedure . 8
7.4 Handling. 8
7.5 Air supply . 8
7.5.1 Equipment . 8
7.5.2 Procedure . 8
© ISO 2019 – All rights reserved iii
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oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
7.6 Water supply . 9
7.6.1 Equipment . 9
7.6.2 Procedure . 9
7.7 Tightness . 9
7.8 Air and water pressure . 9
7.8.1 Equipment . 9
7.8.2 Procedure . 9
7.9 Temperature . 9
7.9.1 Water temperature . 9
7.9.2 Air temperature . 9
7.9.3 Spray temperature. 9
7.10 Air outlet.10
7.11 Backflow preventer .10
7.12 Resistance to reprocessing .11
8 Instructions for use, maintenance and servicing .11
9 Technical description .12
10 Marking .12
10.1 General .12
10.2 Multifunction handpieces .12
11 Labelling .12
12 Packaging .12
Annex A (informative) Example of a test report .13
iv © ISO 2019 – All rights reserved
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oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(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 WTO
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary
information
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
© ISO 2019 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
Introduction
For many years, dental multifunction handpieces (colloquially called “syringes”) have been used in the
field of dentistry to carry out treatment in the oral cavity of the patient.
Technological progress enables continual development of improved and new handpieces with simplified
handling and extended range of applications.
These handpieces are produced by the dental industry as high-quality medical devices under application
of quality management methods.
This document describes the applicable technical properties of products in order to maintain this high
level of quality.
vi © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 22569:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 22569:2019(E)
Dentistry — Multifunction handpieces
1 Scope
This document specifies requirements, test methods, instructions for use and marking for multifunction
handpieces (colloquially called “syringes”) intended to be used in the oral cavity of the patient. The
multifunction handpieces are connected to dental units and provide the user with water, air and spray
for treatment purposes. Some multifunction handpieces provide also illumination of the situs.
This document does not apply to dental handpieces and motors, dental turbines, intraoral cameras,
contra angels, dental polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces,
suction cannulas and saliva ejectors.
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 1942, Dentistry — Vocabulary
ISO 7494-1, Dentistry — Stationary dental units and dental patient chairs — Part 1: General requirements
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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17664, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
ISO 21531, Dentistry — Graphical symbols for dental instruments
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for the 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
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oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
3.1
multifunction handpiece
handpiece, which is supplied with air and water and transfers the water and air directly or as air water
mixture (spray) in the cold and/or the warm state into the oral cavity of the patient
Note 1 to entry: Multifunction handpieces may be additionally equipped with a light function.
Note 2 to entry: Multifunction handpieces may be called as multi-way syringe or multifunction syringe.
4 Classification
4.1 Shape
Multifunction handpieces are classified according to their geometry (as shown in Figure 1 to Figure 3)
as follows:
— angled handpieces;
— straight handpieces;
— curved handpieces.
4.2 Number of functions
The number of transferable fluids such as air, water and spray as well as fluid heating is indicated with
a numerical designation:
Examples
3-function handpiece: water, air, and spray.
6-function handpiece: water, air, spray, warm water, warm air, and warm spray.
In addition the lighting equipment is also indicated if applicable.
Figure 1 — Angled multifunction handpiece
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oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
Figure 2 — Straight multifunction handpiece
Figure 3 — Curved multifunction handpiece
5 Requirements
5.1 General
The safe and reliable operation of multifunction handpieces shall be ensured by their design.
To comply with this requirement the handpiece shall meet the requirements as specified in 5.2 to 5.23.
Multifunction handpieces should be suitable for continuous operation (see IEC 60601-1:2005+AMD1:
2012, 6.6).
All pressure values given in the requirements are flow pressure values.
5.2 Handling
5.2.1 Rotation of cannula
The cannula of the multifunction handpiece used to control the discharged media shall be rotatable
through 360°.
Test in accordance with 7.4.
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5.2.2 Pull-off force of cannula
The pull-off force for removing the cannula and the grip sleeve of the multifunction handpiece shall be
(30 ± 20) N.
This requirement does only apply for handpieces intended for the use with dental units which conform
to ISO 7494-1, and does not apply for handpieces with a lock system (e.g. push button or screw).
Test in accordance with 7.4.
5.3 Maintenance
If the multifunction handpieces are field-repairable according to the manufacturer's indications, they
shall be easy to disassemble and reassemble for maintenance and repair. Either commonly used tools or
special tools supplied by the manufacturer shall be used for this purpose.
IEC 62366-1 shall be followed.
5.4 Materials
5.4.1 General
Materials for the handpiece shall meet all requirements of this document. Choice of materials shall be at
the discretion of the manufacturer.
5.4.2 Biocompatibility
Material tests for biocompatibility shall be conform with ISO 10993-1.
These biocompatibility requirements do not apply to materials which are in contact with water and/or
air only.
5.5 Mechanical strength
IEC 60601-1:2005+AMD1: 2012, 15.3.1 general shall apply.
IEC 60601-1:2005+AMD1: 2012, 15.3.2 push test shall apply.
IEC 60601-1:2005+AMD1: 2012, 15.3.3 impact test shall apply.
IEC 60601-1:2005+AMD1: 2012, 15.3.4.1 drop test, hand-held ME equipment shall apply.
IEC 60601-1:2005+AMD1: 2012, 15.3.6 mould stress relief test, if applicable shall apply.
5.6 Surfaces
Particular attention shall be given to provide secure gripping surfaces for operator manipulation under
normal conditions of use.
Test following the process described in IEC 62366-1.
To reduce glare, polished surfaces should be avoided.
5.7 Air supply
Multifunction handpieces shall be operated by an air supply as indicated by the manufacturer.
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This requirement does only apply for handpieces intended for the use with dental units which conform
to ISO 7494-1: Multifunction handpieces shall be able to transfer an air quantity (flow rate) of no less
1)
than 10 Nl/min with a pressure at the discretion of the manufacturer to the treatment area.
Test in accordance with 7.5.
5.8 Water supply
Multifunction handpieces shall be operated by a water supply as indicated by the manufacturer.
Multifunction handpieces shall be able to transfer a water quantity (flow rate) of at least (50) ml/min
with a pressure at the discretion of the manufacturer to the treatment area.
Test in accordance with 7.6.
5.9 Water outlet
The water shall be discharged in a focussed jet in direction of the cannula without any dripping.
Test in accordance with 7.2.
5.10 Air outlet
The air discharged from the multifunction handpiece shall be dry.
Test in accordance with 7.12.
5.11 Spray outlet
The spray jet shall be discharged in an atomized condition with an angle of no more than 60 degrees to
a central axis normal to the plane of the spray outlet of the cannula.
Test in accordance with 7.3.
5.12 Tightness
During normal use, the housing of the multifunction handpiece shall not show any signs of water
leakage.
Test in accordance with 7.7.
5.13 Air and water pressure
Multifunction handpieces shall remain functional and safe, i.e. they shall not rupture or burst, when
subjected to a pressure 50 % higher than the maximal operating pressure recommended by the
manufacturer.
Test in accordance with 7.8.
5.14 Electrical power supply
These requirements apply only to electrically powered multifunction handpieces.
Multifunction handpieces are connected to the dental unit and are therefore not intended for the direct
connection to the mains supply.
1) Nl/min indicates normal litres per minute, the amount of air that flows through a pipe calculated back to
2 2
“normal” conditions [0 °C and 1 atm or 1,013 25 bar (1 bar = 0,1 MPa = 0,1 N/mm = 105 N/m )].
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oSIST prEN ISO 22569:2019
ISO/DIS 22569:2019(E)
Multifunction handpieces with a fluid heating and/or lighting function
...
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