Dentistry - Multifunction handpieces (ISO 22569:2020)

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.

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 mains multifonctions (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

Status
Published
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
01-Jul-2020
Completion Date
01-Jul-2020

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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

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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.

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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
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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

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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
...

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