SIST EN ISO 5467-1:2023

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
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 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 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 6,
Dental equipment, 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).
A list of all parts in the ISO 5467 series can be found on the ISO website.
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.
iv
ISO 5467-1:2022(E)
Introduction
This document was developed with consideration of ISO 7494-1:2018 to be applicable to mobile dental
units and dental patient chairs by
— limiting the scope to mobile dental units and dental patient chairs,
— providing instability and rough handling requirements in 5.2.1.4 and 5.2.1.5,
— providing a requirement for locking in position in 5.2.1.6,
— providing a requirement for dimension in 5.2.1.7, and
— providing a requirement for impact to 5.2.1.8.
v
INTERNATIONAL STANDARD ISO 5467-1:2022(E)
Dentistry — Mobile dental units and dental patient
chairs —
Part 1:
General requirements
1 Scope
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.
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 4073, Dentistry — Information system on the location of dental equipment in the working area of the
oral health care provider
ISO 5467-2, Dentistry — Mobile dental units and dental patient chairs — Part 2: Air, water, suction and
wastewater systems
ISO 7494-1:2018, Dentistry — Stationary dental units and dental patient chairs — Part 1: General
requirements
ISO 23402-1:2020, Dentistry — Portable dental equipment for use in non-permanent healthcare
environment — Part 1: General requirements
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
IEC 80601-2-60:2019, 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, ISO 4073, ISO 7494-1,
ISO 23402-1, IEC 60601-1, IEC 80601-2-60 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
ISO 5467-1:2022(E)
3.1
mobile dental unit
mobile dental equipment (3.3) designed to provide utilities and amenities for dental treatment, such
as compressed air, water or other liquids, suction, electricity, hand- or foot-activated controllers, work
surfaces, tray supports, cuspidor, and gasses
3.2
mobile dental patient chair
mobile dental equipment (3.3) designed to support and position the patient for treatment and therefore
provided with a range of movements
3.3
mobile dental equipment
transportable dental equipment intended to be moved from one location
...