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 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
• Publication Date: 30-Jun-2020
• Withdrawal Date: 30-Jan-2021
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Jul-2020
• Completion Date: 01-Jul-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: SIST EN ISO 22569:2020 - Dentistry - Multifunction handpieces (ISO 22569:2020)

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
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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.
...