SIST EN ISO 6875:2011
(Main)Dentistry - Patient chair (ISO 6875:2011)
Dentistry - Patient chair (ISO 6875:2011)
This International Standard is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these. This International Standard specifies requirements, test methods, manufacturer’s information, marking and packaging.
Zahnheilkunde - Patientenstuhl (ISO 6875:2011)
Diese Internationale Norm gilt für alle Patientenstühle, unabhängig von ihrer Konstruktion und auch unabhängig davon, ob sie manuell oder elektrisch oder auf andere Weise betrieben werden oder durch eine Kombination davon.
Sie legt Anforderungen, Prüfverfahren, Herstellerangaben, Kennzeichnung und Verpackung fest.
Médecine bucco-dentaire - Fauteuil dentaire (ISO 6875:2011)
L'ISO 6875:2011 s'applique à tous les fauteuils dentaires, quelle que soit leur construction et qu'ils soient commandés manuellement, électriquement ou par tout autre moyen, ou par une combinaison de ces moyens.
L'ISO 6875:2011 spécifie des exigences, des méthodes d'essai, les informations à fournir par le fabricant, le marquage et l'emballage.
Zobozdravstvo - Stol za paciente (ISO 6875:2011)
Ta mednarodni standard velja za stole za bolnike, ne glede na njihovo konstrukcijo in ne glede na to, ali se upravljajo ročno, električno ali kako drugače ali kot kombinacija navedenih možnosti. Ta mednarodni standard določa zahteve, preskusne metode, proizvajalčeve informacije, označevanje in pakiranje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 6875:2011
01-oktober-2011
1DGRPHãþD
SIST EN ISO 6875:2000
Zobozdravstvo - Stol za paciente (ISO 6875:2011)
Dentistry - Patient chair (ISO 6875:2011)
Zahnheilkunde - Patientenstuhl (ISO 6875:2011)
Médecine bucco-dentaire - Fauteuil dentaire (ISO 6875:2011)
Ta slovenski standard je istoveten z: EN ISO 6875:2011
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 6875:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 6875:2011
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SIST EN ISO 6875:2011
EUROPEAN STANDARD
EN ISO 6875
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2011
ICS 11.060.20 Supersedes EN ISO 6875:1996
English Version
Dentistry - Patient chair (ISO 6875:2011)
Médecine bucco-dentaire - Fauteuil dentaire (ISO Zahnheilkunde - Patientenstuhl (ISO/FDIS 6875:2011)
6875:2011)
This European Standard was approved by CEN on 30 June 2011.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6875:2011: E
worldwide for CEN national Members.
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SIST EN ISO 6875:2011
EN ISO 6875:2011 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 6875:2011
EN ISO 6875:2011 (E)
Foreword
This document (EN ISO 6875:2011) 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 2012, and conflicting national standards shall be withdrawn at
the latest by January 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 6875:1996.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 6875:2011 has been approved by CEN as a EN ISO 6875:2011 without any modification.
3
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SIST EN ISO 6875:2011
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SIST EN ISO 6875:2011
INTERNATIONAL ISO
STANDARD 6875
Third edition
2011-07-01
Dentistry — Patient chair
Médecine bucco-dentaire — Fauteuil dentaire
Reference number
ISO 6875:2011(E)
©
ISO 2011
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SIST EN ISO 6875:2011
ISO 6875:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
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SIST EN ISO 6875:2011
ISO 6875:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 6875 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.
This third edition cancels and replaces the second edition (ISO 6875:1995), which has been technically revised.
The following changes were made:
a) the requirements were aligned with IEC 60601-1:2005;
b) the mass distribution for the different parts of the patient chair was changed to percent distribution in order
to allow the manufacturer to provide for a mass of more than 135 kg;
c) the requirements for the technical description and the labelling were updated.
© ISO 2011 – All rights reserved iii
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SIST EN ISO 6875:2011
ISO 6875:2011(E)
Introduction
Specific qualitative and quantitative test methods for freedom from biological hazard are not included in this
International Standard. However, it is recommended that, for the assessment of possible biological hazards,
reference be made to ISO 10993-1.
iv © ISO 2011 – All rights reserved
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SIST EN ISO 6875:2011
INTERNATIONAL STANDARD ISO 6875:2011(E)
Dentistry — Patient chair
1 Scope
This International Standard is applicable to all patient chairs, regardless of their construction, and regardless of
whether they are operated manually, electrically or by other means, or as a combination of these.
This International Standard specifies requirements, test methods, manufacturer’s information, marking
and packaging.
2 Normative references
The following referenced documents are indispensable for the application 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 8191-1, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source:
smouldering cigarette
ISO 9687, Dental equipment — Graphical symbols
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
ISO/IEC 80601-2-60:2011, Medical electrical equipment — Part 2-60: Particular requirements for basic safety
and essential performance of dental equipment
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 62366, Medical devices — Application of usability engineering to medical devices
IEC 62353, Medical electrical equipment — Recurrent test and test after repair of medical electrical equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 60601-1 and
ISO/IEC 80601-2-60 and the following apply.
3.1
patient chair
device equipped with a range of movements, designed to support and position the patient for dental treatment
4 Classification
4.1 General
This classification applies to electrically operated patient chairs only.
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SIST EN ISO 6875:2011
ISO 6875:2011(E)
4.2 According to type of protection against electric shock
Patient chairs are classified in accordance with IEC 60601-1 as follows:
a) Class I equipment, see IEC 60601-1:2005, 3.13.
b) Class II equipment, see IEC 60601-1:2005, 3.14.
4.3 According to degree of protection against electric shock
If a patient chair has an applied part it shall be classified as Type B, see IEC 60601-1:2005, 3.132.
4.4 According to mode of operation
IEC 60601-1:2005, 6.6 applies.
NOTE Patient chairs are intended for non-continuous operation.
5 Requirements
5.1 General requirements
5.1.1 Electrical requirements
Electrical requirements are only applicable to electrically operated patient chairs. There are, however, general
requirements given in IEC 60601-1, which are also applicable to non-electrical patient chairs.
IEC 60601-1 and ISO/IEC 80601-2-60 apply.
5.1.2 Moving parts
IEC 60601-1:2005, 9.2 applies.
Testing shall be carried out in accordance with 7.2.1.
5.1.3 Operating controls
Operating controls shall be designed and located to minimize accidental activation. Graphical symbols for
operating controls and performance shall be in accordance with ISO 9687.
IEC 60601-1:2005, 15.1 applies.
5.1.4 Usability
Testing shall be carried out in accordance with IEC 62366.
5.1.5 Function stop system
The patient chair shall incorporate at least one function stop system which is located so that it can be easily
activated by the dentist and/or the operating personnel and which, when activated, instantly stops all functions
that could be hazardous to the patient and the dental personnel.
EXAMPLE Foot control is a suitable function stop system.
Testing shall be carried out in accordance with 7.1.
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SIST EN ISO 6875:2011
ISO 6875:2011(E)
5.1.6 Upholstery and padding
5.1.6.1 Resistance to liquid absorption
Covering upholstery materials shall be resistant to liquid absorption.
Testing shall be carried out in accordance with 7.1.
Covering materials that are suitable for cleaning and disinfection with agents
...
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