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

Status
Published
Publication Date
11-Oct-2022
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
12-Oct-2022
Due Date
07-Apr-2024
Completion Date
12-Oct-2022

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SLOVENSKI STANDARD
SIST EN ISO 5467-1:2023
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
SIST EN ISO 5467-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5467-1:2023

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SIST EN ISO 5467-1:2023


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.

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SIST EN ISO 5467-1:2023
EN ISO 5467-1:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 5467-1:2023
EN ISO 5467-1:2022 (E)
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.

3

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SIST EN ISO 5467-1:2023

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SIST EN ISO 5467-1:2023
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 2022

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SIST EN ISO 5467-1:2023
ISO 5467-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 2022 – All rights reserved

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SIST EN ISO 5467-1:2023
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 2022 – All rights reserved

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SIST EN ISO 5467-1:2023
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 2022 – All rights reserved

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SIST EN ISO 5467-1:2023
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
© ISO 2022 – All rights reserved

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SIST EN ISO 5467-1:2023

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SIST EN ISO 5467-1:2023
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/
1
© ISO 2022 – All rights reserved

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SIST EN ISO 5467-1:2023
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 5467-1:2022
01-januar-2022
Zobozdravstvo - Mobilne zobozdravstvene enote in stoli za paciente - 1. del:
Splošne zahteve (ISO/DIS 5467-1:2021)
Dentistry - Mobile dental units and patient chairs - Part 1: General requirements
(ISO/DIS 5467-1:2021)
Zahnheilkunde - Mobile Behandlungseinheiten und Patientenliegen - Teil 1: Allgemeine
Anforderungen (ISO/DIS 5467 1:2021)
Médecine bucco-dentaire - Partie 1: Exigences générales (ISO/DIS 5467-1:2021)
Ta slovenski standard je istoveten z: prEN ISO 5467-1
ICS:
11.060.20 Zobotehnična oprema Dental equipment
oSIST prEN ISO 5467-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 5467-1:2022

---------------------- Page: 2 ----------------------
oSIST prEN ISO 5467-1:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5467-1
ISO/TC 106/SC 6 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-11-23 2022-02-15
Dentistry — Mobile dental units and patient chairs —
Part 1:
General requirements
Partie 1: Exigences générales
ICS: 11.060.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5467-1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021

---------------------- Page: 3 ----------------------
oSIST prEN ISO 5467-1:2022
ISO/DIS 5467-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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 2021 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 5467-1:2022
ISO/DIS 5467-1:2021(E)
Contents Page
Foreword .iv
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 . 3
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. 6
5.3.1 General electrical requirements . 6
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 Mechanical tests . 6
7.2.1 Measurement of solids filter . 6
7.2.2 Pressure vessels and parts subject to pneumatic or hydraulic pressure . 7
7.2.3 Headrest of mobile dental patient chair . 7
7.2.4 Armrest of mobile dental patient chair . 7
7.2.5 Vertical lift of mobile dental patient chair . 7
7.2.6 Tipping and stability of mobile dental patient chair . 7
7.3 Electrical tests . 8
7.3.1 Position limiting of mobile dental patient chair . 8
7.3.2 Function stop system of mobile dental patient chairs . 8
8 Manufacturer's instructions . 9
8.1 General . 9
8.2 Instructions for use . 9
8.3 Technical description. 9
9 Marking . . 9
10 Packaging. 9
Annex A (informative) Example of a test report.10
Bibliography .14
iii
© ISO 2021 – All rights reserved

---------------------- Page: 5 ----------------------
oSIST prEN ISO 5467-1:2022
ISO/DIS 5467-1:2021(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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This first edition of ISO 5467-1 was developed in consideration of ISO 7494-1:2018 to be applicable to
mobile dental units and dental patient chairs. The main changes compared to ISO 7494-1:2018 are as
follows:
— the scope was limited to mobile dental units and dental patient chairs;
— instability and rough handling requirements were added to 5.2.1.4 and 5.2.1.5;
— requirement for locking in position was added to 5.2.1.6;
— requirement for dimension was added to 5.2.1.7;
— requirement for impact was added to 5.2.1.8.
A list of all parts in the ISO 5467 series can be found on the ISO website.
iv
  © ISO 2021 – All rights reserved

---------------------- Page: 6 ----------------------
oSIST prEN ISO 5467-1:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 5467-1:2021(E)
Dentistry — Mobile dental units and patient chairs —
Part 1:
General requirements
1 Scope
This document specifies 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 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 7494-1:2018, Dentistry — Stationary dental units and dental patient chairs — Part 1: General
requirements
ISO 5467-2, Dentistry — Mobile dental units and dental patient chairs — Part 2: Air, water, suction and
wastewater systems
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
ISO 23402-1, Dentistry — Portable dental equipment for use in non‐permanent healthcare environment —
Part 1: General requirements
I EC 6 06 01-1:20 05+A M D1: 2012 , 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 and IEC 80601-2-60 and the following apply.
1
© ISO 2021 – All rights reserved

---------------------- Page: 7 ----------------------
oSIST prEN ISO 5467-1:2022
ISO/DIS 5467-1:2021(E)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
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 to another while supported by
its own wheels or equivalent means
Note 1 to entry: Mobile dental units and dental patient chairs are categorized into this group.
Note 2 to entry: The meaning of transport defined in the IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 9.4.2.1 is
moving the mobile dental units and dental patient chairs from room to room during normal use.
4 Classification
Clause 4 of ISO 7494-1:2018 applies.
Test in accordance with 7.1.2.
5 Requirements
5.1 General requirements
5.1.1 Basic safety and essential performance
The requirements specified in 5.1.1 of ISO 7494-1:2018 applies by replacing dental unit and dental
patient chair with mobile dental unit and mobile dental patient chair.
Conformity shall be checked in accordance with IEC 60601-1 and IEC 80601-2-60.
5.1.2 Controls and indicators
The requirements and NOTE specified in 5.1.2 of ISO 7494-1:2018 applies.
Conformity shall be checked in accordance with IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020.
5.1.3 Function stop system
The requirements and EXAMPLE specified in 5.1.3 of ISO 7494-1:2018 applies by replacing dental unit
and dental patient chair with mobile dental unit and mobile dental patient chair.
Test in accordance with 7.3.2.
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oSIST prEN ISO 5467-1:2022
ISO/DIS 5467-1:2021(E)
5.1.4 Usability
The requirements specified in 5.1.4 of ISO 7494-1:2018 applies.
Test in accordance with 7.1.2.
5.1.5 Cleaning and disinfection
The requirements specified in 5.1.5 of ISO 7494-1:2018 applies by replacing dental unit and dental
patient chair with mobile dental unit and mobile dental patient chair.
Test in accordance with ISO 21530.
5.1.6 Excessive temperatures
The requirements specified in 5.1.6 of ISO 7494-1:2018 applies.
Test in accordance with IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020 and IEC 80601-2-60:2019.
5.1.7 Biocompatibility
The requirements specified in 5.1.7 of ISO 7494-1:2018 applies.
Biocompatibility shall be assessed in accordance with ISO 10993-1.
5.1.8 Solids filter
The requirements specified in 5.1.8 of ISO 7494-1:2018 applies by replacing dental unit with mobile
dental unit.
Test in accordance with 7.2.1.
5.1.9 Amalgam separator device
The requirements specified in 5.1.9 of ISO 7494-1:2018
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