SIST EN ISO 7494-1:2018
(Main)Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements (ISO 7494-1:2018)
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements (ISO 7494-1:2018)
This document specifies requirements and test methods for stationary dental units, dental patient
chairs, and combinations of both 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, portable dental equipment and operating lights are not in the scope of this document.
Zahnheilkunde - Fest installierte Behandlungseinheiten und Patientenstühle - Teil 1: Allgemeine Anforderungen und Prüfverfahren (ISO 7494-1:2018)
Médecine bucco-dentaire - Units dentaires fixes et fauteuils dentaires patient - Partie 1: Exigences générales (ISO 7494-1:2018)
Le présent document spécifie les exigences et les méthodes d'essai relatives aux unités dentaires fixes, aux fauteuils dentaires patient et aux combinaisons des deux, qu'ils soient ou non commandés électriquement.
Le présent document spécifie également les exigences relatives à la notice d'utilisation, à la description technique, au marquage et à l'emballage.
Les sièges d'opérateur, l'équipement dentaire portable et les scialytiques ne relèvent pas du domaine d'application du présent document.
Zobozdravstvo - Stacionarne dentalne enote in stoli za paciente - 1. del: Splošne zahteve (ISO 7494-1:2018)
Ta dokument določa zahteve in preskusne metode za stacionarne dentalne enote, stole za paciente in kombinacije obeh, ne glede na to, ali so električni ali ne.
Ta dokument določa tudi zahteve za navodila za uporabo, za tehnični opis, za označevanje in pakiranje.
Stoli za upravljavce, prenosna zobna oprema in delovne luči ne spadajo na področje uporabe tega dokumenta.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7494-1:2018
01-oktober-2018
1DGRPHãþD
SIST EN ISO 6875:2011
SIST EN ISO 7494-1:2011
Zobozdravstvo - Stacionarne dentalne enote in stoli za paciente - 1. del: Splošne
zahteve (ISO 7494-1:2018)
Dentistry - Stationary dental units and dental patient chairs - Part 1: General
requirements (ISO 7494-1:2018)
Zahnheilkunde - Fest installierte Behandlungseinheiten und Patientenstühle - Teil 1:
Allgemeine Anforderungen und Prüfverfahren (ISO 7494-1:2018)
Médecine bucco-dentaire - Units dentaires fixes et fauteuils dentaires patient - Partie 1:
Exigences générales (ISO 7494-1:2018)
Ta slovenski standard je istoveten z: EN ISO 7494-1:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 7494-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7494-1:2018
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SIST EN ISO 7494-1:2018
EN ISO 7494-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 6875:2011, EN ISO 7494-1:2011
English Version
Dentistry - Stationary dental units and dental patient
chairs - Part 1: General requirements (ISO 7494-1:2018)
Médecine bucco-dentaire - Units dentaires fixes et Zahnheilkunde - Fest installierte
fauteuils dentaires patient - Partie 1: Exigences Behandlungseinheiten und Patientenstühle - Teil 1:
générales (ISO 7494-1:2018) Allgemeine Anforderungen und Prüfverfahren (ISO
7494-1:2018)
This European Standard was approved by CEN on 27 May 2018.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7494-1:2018 E
worldwide for CEN national Members.
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SIST EN ISO 7494-1:2018
EN ISO 7494-1:2018 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 7494-1:2018
EN ISO 7494-1:2018 (E)
European foreword
This document (EN ISO 7494-1:2018) 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 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
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.
This document supersedes EN ISO 6875:2011 and EN ISO 7494-1:2011.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7494-1:2018 has been approved by CEN as EN ISO 7494-1:2018 without any
modification.
3
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SIST EN ISO 7494-1:2018
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SIST EN ISO 7494-1:2018
INTERNATIONAL ISO
STANDARD 7494-1
Third edition
2018-06
Dentistry — Stationary dental units
and dental patient chairs —
Part 1:
General requirements
Médecine bucco-dentaire — Units dentaires fixes et fauteuils
dentaires patient —
Partie 1: Exigences générales
Reference number
ISO 7494-1:2018(E)
©
ISO 2018
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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.
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
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 .4
5.2 Mechanical requirements.4
5.2.1 General mechanical requirements .4
5.2.2 Mechanical requirements for dental units .4
5.2.3 Mechanical requirements for 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 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 .7
7.2.1 Measurement of solids filter.7
7.2.2 Pressure vessels and parts subject to pneumatic or hydraulic pressure .7
7.2.3 Headrest of dental patient chair .7
7.2.4 Armrest of dental patient chair .7
7.2.5 Vertical lift of dental patient chair .7
7.2.6 Tipping and stability of dental patient chair .7
7.3 Electrical tests .8
7.3.1 Position limiting of dental patient chair.8
7.3.2 Function stop system . .8
8 Manufacturer's instructions . 9
8.1 General . 9
8.2 Instructions for use .9
8.3 Technical description .9
9 Marking .10
9.1 Product marking . 10
9.2 Marking of packaging . 10
10 Packaging .10
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
Annex A (informative) Example of a test report .12
Bibliography .18
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(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 third edition of ISO 7494-1 cancels and replaces ISO 7494-1:2011 and ISO 6875:2011, which has
been technically revised.
A list of all parts in the ISO 7494 series can be found on the ISO website.
© ISO 2018 – All rights reserved v
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SIST EN ISO 7494-1:2018
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SIST EN ISO 7494-1:2018
INTERNATIONAL STANDARD ISO 7494-1:2018(E)
Dentistry — Stationary dental units and dental patient
chairs —
Part 1:
General requirements
1 Scope
This document specifies requirements and test methods for stationary dental units, dental patient
chairs, and combinations of both 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, 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 7494-2, Dentistry — Dental units — Part 2: Air, water, suction and wastewater systems
ISO 8191-1, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source:
smouldering cigarette
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11143, Dentistry — Amalgam separators
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
IEC 60601-1:2005+AMD1: 2012, 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 62353, Medical electrical equipment — Recurrent test and test after repair of medical electrical
equipment
IEC 80601-2-60:2012, Medical electrical equipment — Part 2-60: Particular requirements for basic safety
and essential performance of dental equipment
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 60601-
1:2005 + AMD1: 2012 and IEC 80601-2-60:2012 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
dental unit
assembly of devices 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
dental patient chair
device designed to support and position the patient for treatment and therefore provided with a range
of movements
3.3
dental handpiece
handheld instrument used in dentistry for use in patient treatment and connected to the dental unit (3.1)
[SOURCE: IEC 80601-2-60:2012, 201.3.203]
4 Classification
Classification according to IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-60:2012 shall apply.
5 Requirements
5.1 General requirements
5.1.1 Basic safety and essential performance
IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-60:2012 shall apply to dental units, to electrical dental
patient chairs and to non-electrical dental patient chairs.
Conformity shall be checked in accordance with IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-
60:2012.
5.1.2 Controls and indicators
Controls and indicators shall be designed and located to minimize accidental activation. For
arrangement of controls and indicators IEC 60601-1:2005 + AMD1: 2012, 15.1 shall apply.
NOTE Standardized graphical symbols for controls and indicators are specified in ISO 9687.
Conformity shall be checked in accordance with IEC 60601-1:2005 + AMD1: 2012.
5.1.3 Function stop system
Electrically powered dental patient chairs shall incorporate at least one function stop system which is
located so that it can be easily activated by the operating personnel and which, when activated, instantly
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
stops all powered movements of the dental patient chair that could be hazardous to the patient and/or
the operating personnel.
EXAMPLE A foot control capable of immediately stopping all powered movements of the dental patient chair
is a suitable function stop system.
Testing shall be carried out in accordance with 7.3.2.
5.1.4 Usability
Usability evaluation shall be carried out following the process described in IEC 62366-1.
Testing shall be carried out in accordance with IEC 62366-1.
5.1.5 Cleaning and disinfection
All materials used for external and touchable surfaces of the dental unit and dental patient chair which
can be contaminated by aerosols, splatters and droplets in normal use shall be capable to be cleaned
and disinfected without deterioration or discoloration when tested in accordance with ISO 21530 and
using the relevant cleaning agents and disinfectant agents recommended by the manufacturer.
Testing shall be carried out in accordance with ISO 21530.
5.1.6 Excessive temperatures
IEC 60601-1:2005 + AMD1: 2012, 11.1 and IEC 80601-2-60:2012, 201.11 shall apply.
Testing shall be carried out in accordance with IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-
60:2012.
5.1.7 Biocompatibility
ISO 10993-1 shall apply.
Biocompatibility shall be assessed in accordance with ISO 10993-1.
5.1.8 Solids filter
Dental units with a waste water system shall contain a solids filter. The solids filter shall be capable of
retaining solid particles with a diameter of ≥ 2 mm.
Testing shall be carried out in accordance with 7.2.1.
5.1.9 Amalgam separator device
If the dental unit is equipped with or capable to be equipped with an amalgam separator device, this
device shall conform to ISO 11143.
Testing shall be carried out in accordance with 7.1.2.
5.1.10 Upholstery and padding
5.1.10.1 Resistance to liquid absorption
Covering upholstery materials shall be resistant to liquid absorption.
Testing shall be carried out in accordance with 7.1.1.
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
5.1.10.2 Flammability
Testing shall be carried out in accordance with ISO 8191-1.
When tested, the upholstery and padding shall not ignite. Resultant charring, if any, shall be not greater
in length than 30 mm in any direction measured from the nearest point of the test cigarette.
Conformity shall be checked in accordance with 7.1.1
5.1.11 Air, water suction and waste water systems
For air, water suction and waste water systems of dental units and dental patient chairs ISO 7494-2
shall apply.
Testing shall be carried out in accordance with ISO 7494-2.
5.2 Mechanical requirements
5.2.1 General mechanical requirements
5.2.1.1 Moving parts
IEC 60601-1:2005 + AMD1: 2012, 9.2 shall apply.
Conformity shall be checked in accordance with IEC 60601-1:2005 + AMD1: 2012.
5.2.1.2 Pressure vessels and parts subject to pneumatic or hydraulic pressure
Pressure vessels and parts subject to pneumatic or hydraulic pressure used in dental units and dental
patient chairs shall be capable of withstanding, without bursting or leaking, the pressure test specified
in 7.2.2.
5.2.1.3 Mechanical hazards associated with surfaces, corners and edges
IEC 60601-1:2005 + AMD1: 2012, 9.3 shall apply.
Conformity shall be checked in accordance with IEC 60601-1:2005 + AMD1: 2012.
5.2.1.4 Stability of support systems
IEC 60601-1:2005 + AMD1: 2012, 9.4 and 9.8 shall apply.
Conformity shall be checked in accordance with IEC 60601-1:2005 + AMD1: 2012.
5.2.2 Mechanical requirements for dental units
5.2.2.1 Handpiece hoses
Handpiece hoses connected to the dental unit should be disconnectable for cleaning and disinfection.
For hoses for air driven dental handpieces ISO 9168 shall apply.
For hoses for other dental handpieces the hose connector is determined by the manufacturer.
Testing shall be carried out in accordance with 7.1.1.
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SIST EN ISO 7494-1:2018
ISO 7494-1:2018(E)
5.2.3 Mechanical requirements for dental patient chairs
5.2.3.1 Maximum patient mass and static loading
The maximum patient mass shall be specified by the manufacturer and shall be at least 150 kg. The
mass distribution to be used in testing shall be in accordance with Table 1.
If the patient chair is intended to support a patient mass greater than 150 kg, the mass distribution
shall be distributed proportionally according to the %-values given in Table 1.
Table 1 — Patient mass distribution
Example:
Mass distribution
Part of patient
Mass distribution for 150 kg
supported by dental patient chair
% patient
kg (rounded)
Head and neck 7,4 11
Upper trunk and upper arms 33,4 50
Lower trunk, lower arms and hands, thighs 40,7 61
Legs and feet 18,5 28
Total patient 100 150
The static loading requirements of IEC 60601-1:2005 + AMD1: 2012, 9.8 and IEC 80601-2-60:2012, 201.9
shall apply when the dental patient chair is in the most unfavourable position.
Testing shall be carried out in accordance with IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-
60:2012 under static load condition.
5.2.3.2 Stability of headrest
The headrest shall be capable of withstanding the force specified in 7.2.3 without failure and without
risk to the patient or operating personnel. This force simulates unintentional movements and the
weight of the patient's head, including any additional load applied by the operating personnel and the
force imparted to the headrest by the patient due to arching of his/her body.
Testing shall be carried out in accordance with 7.2.3.
5.2.3.3 Stability of armrests
Armrests, if provided, shall be capable of withstanding, without failure or permanent deformation the
force specified in 7.2.4. Armrests designed to be movable horizontally or vertically shall be capable of
withstanding the loads specified in 7.2.4 without their function becoming permanently impaired.
Testing shall be carried out in accordance with 7.2.4.
5.2.3.4 Loading capacity and vertical lift
Dental patient chairs shall be capable of supporting and lifting the maximum patient mass specified by
the manufacturer, distributed according to Table 1, plus the movable mass of additional mounted items,
plus any accessory devices specified by the manufacturer as additional lifting capability. The dental
patient chair shall not sink more than 10 mm in 1 h.
Testing shall be carried out in accordance with 7.2.5.
5.2.3.5 Tipping and stability
The dental patient chair shall not overbalance and no part of the base edge shall lift off of the ground by
more than 5 mm when tested in accordance with 7.2.6.
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ISO 7494-1:2018(E)
5.3 Electrical requirements
5.3.1 General electrical requirements
Electrical requirements are only applicable to electrically operated dental units and dental patient chairs.
IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-60:2012 shall apply.
Conformity shall be checked in accordance with IEC 60601-1:2005 + AMD1: 2012 and IEC 80601-2-
60:2012.
5.3.2 Test points for periodic safety checks
In order to perform the safety checks specified in IEC 62353, dental units and dental patient chairs
shall have a connector/plug for the power supply.
Testing shall be carried out in accordance with 7.1.1.
NOTE To simplify the periodic safety checks a plug is preferred.
5.3.3 Position limiting of dental patient chair
In case of a single-fault condition of a limit switch or other means controlling dental patient chair
movement, additional protective means shall be provided.
EXAMPLE Mechanical limits to prevent injury to the patient and/or
...
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