EN ISO 5467-1:2022
(Main)Dentistry - Mobile dental units and dental patient chairs - Part 1: General requirements (ISO 5467-1:2022)
Dentistry - Mobile dental units and dental patient chairs - Part 1: General requirements (ISO 5467-1:2022)
This document specifies the requirements and test methods for mobile dental units and dental patient chairs that is intended to be used within a permanent healthcare facility regardless of whether they are or not electrically powered.
This document also specifies the requirements for the instructions for use, for the technical description, for marking and for packaging.
Operator's stools, stationary dental equipment, other types of mobile dental equipment, portable dental equipment and operating lights are not in the scope of this document.
Zahnheilkunde - Mobile dentale Behandlungseinheiten und dentale Patientenliegen - Teil 1: Allgemeine Anforderungen (ISO 5467-1:2022)
Dieses Dokument legt Anforderungen und Prüfverfahren für mobile dentale Behandlungseinheiten und dentale Patientenliegen fest, die zur Anwendung innerhalb einer dauerhaften Einrichtung des Gesundheitswesens bestimmt sind, unabhängig davon, ob sie elektrisch angetrieben werden oder nicht.
Dieses Dokument legt auch Anforderungen an die Gebrauchsanweisung, die technische Beschreibung, die Kennzeichnung und die Verpackung fest.
Arbeitsstühle, fest installierte dentale Ausrüstung, andere Arten von mobiler dentaler Ausrüstung, tragbare dentale Ausrüstung und Behandlungsleuchten fallen nicht in den Anwendungsbereich dieses Dokuments.
Dieses Dokument legt Anforderungen und Prüfverfahren für mobile dentale Behandlungseinheiten und dentale Patientenliegen fest, die zur Anwendung innerhalb einer dauerhaften Einrichtung des Gesundheitswesens bestimmt sind, unabhängig davon, ob sie elektrisch angetrieben werden oder nicht.
Dieses Dokument legt auch Anforderungen an die Gebrauchsanweisung, die technische Beschreibung, die Kennzeichnung und die Verpackung fest.
Arbeitsstühle, fest installierte dentale Ausrüstung, andere Arten von mobiler dentaler Ausrüstung, tragbare dentale Ausrüstung und Behandlungsleuchten fallen nicht in den Anwendungsbereich dieses Dokuments.
Médecine bucco-dentaire - Units dentaires et fauteuils dentaires patient mobiles - Partie 1: Exigences générales (ISO 5467-1:2022)
Le présent document spécifie les exigences et les méthodes d’essai relatives aux units dentaires et aux fauteuils dentaires patient mobiles qui sont destinés à être utilisés dans un établissement de soins de santé permanent, qu’ils soient électriques ou non.
Le présent document spécifie également les exigences relatives aux instructions d'utilisation, à la description technique, au marquage et à l’emballage.
Les tabourets pour opérateurs, le matériel dentaire fixe, les autres types de matériel dentaire mobile, le matériel dentaire portatif et les lampes d’opération ne font pas partie du domaine d’application du présent document.
Zobozdravstvo - Mobilne dentalne enote in stoli za paciente - 1. del: Splošne zahteve (ISO 5467-1:2022)
Ta dokument določa zahteve in preskusne metode za brizge za mobilne dentalne enote.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2023
Zobozdravstvo - Mobilne dentalne enote in stoli za paciente - 1. del: Splošne
zahteve (ISO 5467-1:2022)
Dentistry - Mobile dental units and dental patient chairs - Part 1: General requirements
(ISO 5467-1:2022)
Zahnheilkunde - Mobile Behandlungseinheiten und Patientenliegen - Teil 1: Allgemeine
Anforderungen (ISO 5467-1:2022)
Médecine bucco-dentaire - Units dentaires et fauteuils dentaires patient mobiles - Partie
1: Exigences générales (ISO 5467-1:2022)
Ta slovenski standard je istoveten z: EN ISO 5467-1:2022
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5467-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Mobile dental units and dental patient chairs -
Part 1: General requirements (ISO 5467-1:2022)
Médecine bucco-dentaire - Units dentaires et fauteuils Zahnheilkunde - Mobile Behandlungseinheiten und
dentaires patient mobiles - Partie 1: Exigences Patientenliegen - Teil 1: Allgemeine Anforderungen
générales (ISO 5467-1:2022) (ISO 5467-1:2022)
This European Standard was approved by CEN on 6 September 2022.
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, Türkiye 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5467-1:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5467-1:2022) 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 April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5467-1:2022 has been approved by CEN as EN ISO 5467-1:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 5467-1
First edition
2022-09
Dentistry — Mobile dental units and
dental patient chairs —
Part 1:
General requirements
Médecine bucco-dentaire — Units dentaires et fauteuils dentaires
patient mobiles —
Partie 1: Exigences générales
Reference number
ISO 5467-1:2022(E)
ISO 5467-1:2022(E)
© ISO 2022
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: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
ISO 5467-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General requirements . 2
5.1.1 Basic safety and essential performance . 2
5.1.2 Controls and indicators . 2
5.1.3 Function stop system . 2
5.1.4 Usability . 2
5.1.5 Cleaning and disinfection . 3
5.1.6 Excessive temperatures . 3
5.1.7 Biocompatibility . 3
5.1.8 Solids filter . 3
5.1.9 Amalgam separator device . 3
5.1.10 Upholstery and padding . 3
5.1.11 Air, water, suction, and waste water systems . 3
5.2 Mechanical requirements . 4
5.2.1 General mechanical requirements . 4
5.2.2 Mechanical requirements for mobile dental units . 5
5.2.3 Mechanical requirements for mobile dental patient chairs . 5
5.3 Electrical requirements. 5
5.3.1 General electrical requirements . 5
5.3.2 Test points for periodic safety checks . 6
5.3.3 Position limiting of mobile dental patient chair . 6
5.4 Test report . 6
6 Sampling . 6
7 Testing. 6
7.1 Visual inspection . 6
7.1.1 Visual inspection of device . 6
7.1.2 Visual inspection of documentation or test reports . . 6
7.2 Tipping and stability of mobile dental patient chair. 6
8 Instructions for use . .7
9 Technical description .8
10 Marking . . 8
11 Packaging. 8
Annex A (informative) Example of a test report. 9
Bibliography .13
iii
ISO 5467-1:2022(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
...
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