SIST EN ISO 22569:2020

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 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

• Status: Published
• Public Enquiry End Date: 19-Jul-2019
• Publication Date: 10-Aug-2020
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Jul-2020
• Due Date: 18-Sep-2020
• Completion Date: 11-Aug-2020
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Ref Project: EN ISO 22569:2020 - Dentistry - Multifunction handpieces (ISO 22569:2020)

Overview

EN ISO 22569:2020 - Dentistry: Multifunction handpieces (ISO 22569:2020) specifies requirements, test methods, instructions for use and marking for multifunction dental handpieces (commonly called “syringes”) intended for use in the oral cavity. Prepared by ISO/TC 106 in collaboration with CEN/TC 55, this harmonized European and international standard covers classification, performance, safety and reprocessing considerations for these dental devices. It does not apply to dental handpieces and motors, intraoral cameras, polymerisation lamps, powered scalers, powder-jet or prophy handpieces, suction cannulas or saliva ejectors.

Key topics and requirements

The standard addresses technical and safety topics relevant to manufacturers, test labs and regulatory reviewers:

• Scope & classification: shape, number of functions, single‑use vs reusable cannula
• General requirements: materials, mechanical strength and surface properties
• Handling: rotation and pull-off force of cannula, usability and operating controls
• Fluid and air systems: air and water supply, water/air outlets, spray outlet, tightness and pressure requirements
• Temperature control: water, air and spray temperature limits and housing temperature rise
• Backflow prevention: provisions to reduce cross-contamination risk
• Reprocessing: instructions for use, resistance to cleaning/sterilization and verification after reprocessing
• Testing & measurement: sampling, visual inspection, spray angle, pressure and tightness tests, and reporting
• Marking, labelling and packaging: required information for safe operation and traceability

Practical applications and users

EN ISO 22569:2020 is primarily used by:

• Dental device manufacturers designing and certifying multifunction handpieces
• Test laboratories performing conformity, performance and safety testing
• Regulatory and conformity assessment bodies verifying compliance with CEN/ISO requirements
• Dental clinics and procurement teams specifying equipment that meets harmonized safety and reprocessing criteria
• Sterilization service providers ensuring reprocessing instructions are adequate and validated

Benefits include improved device safety, consistent test procedures, clearer labelling and reduced infection risk through standardized backflow prevention and reprocessing requirements.

Related standards (context)

EN ISO 22569:2020 complements other dentistry and medical device standards developed by ISO/TC 106 and national CEN members - notably standards addressing dental handpieces, sterilization processes and medical device labelling and instructions for use. For regulatory alignment, refer to applicable regional medical device regulations and harmonized standards lists.

Keywords: EN ISO 22569:2020, multifunction handpieces, dental syringes, dentistry standard, test methods, backflow prevention, reprocessing, dental device marking.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.

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
ISO 22569:2020(E)
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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 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

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 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

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 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

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 Requirement
...