EN 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 dentale Behandlungseinheiten und dentale Patientenliegen - Teil 1: Allgemeine Anforderungen (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

• Status: Published
• Publication Date: 24-Jul-2018
• Withdrawal Date: 30-Jan-2019
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 25-Jul-2018
• Due Date: 25-Jul-2018
• Completion Date: 25-Jul-2018
• Ref Project: SIST EN ISO 7494-1:2018 - Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements (ISO 7494-1:2018)

Relations

• Replaces: EN ISO 7494-1:2011 - Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
• Effective Date: 01-Aug-2018
• Replaces: EN ISO 6875:2011 - Dentistry - Patient chair (ISO 6875:2011)
• Effective Date: 30-Mar-2016

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO 7494-1:2018(E)
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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
ISO 7494-1:2018(E)
Annex A (informative) Example of a test report .12
Bibliography .
...