SIST EN ISO 7494-1:2011
(Main)Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
ISO 7494-1:2011 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered.
ISO 7494-1:2011 also specifies requirements for manufacturer's instructions, marking and packaging.
Zahnheilkunde - Zahnärztliche Behandlungsgeräte - Teil 1: Allgemeine Anforderungen und Prüfverfahren (ISO 7494-1:2011)
Dieser Teil von ISO 7494 legt Anforderungen und Prüfverfahren für zahnärztliche Behandlungsgeräte fest, unabhängig davon, ob sie elektrisch oder nicht elektrisch betrieben werden.
Er enthält auch Anforderungen an die Gebrauchsanweisung, Kennzeichnung und Verpackung.
Médecine bucco-dentaire - Units dentaires - Partie 1: Exigences et méthodes d'essai générales (ISO 7494-1:2011)
L'ISO 7494-1:2011 spécifie les exigences et les méthodes d'essai relatives aux units dentaires, qu'ils soient mus électriquement ou non.
L'ISO 7494-1:2011 spécifie également les exigences relatives aux instructions du fabricant, au marquage et à l'emballage.
Zobozdravstvo - Dentalne enote - 1. del: Splošne zahteve in preskusne metode (ISO 7494-1:2011)
Ta del ISO 7494 določa zahteve in preskusne metode za dentalne enote, ne glede na to, ali so na električni pogon ali ne. Prav tako določa zahteve za navodila proizvajalca, označevanje in pakiranje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7494-1:2011
01-december-2011
1DGRPHãþD
SIST EN ISO 7494-1:2005
Zobozdravstvo - Dentalne enote - 1. del: Splošne zahteve in preskusne metode
(ISO 7494-1:2011)
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-
1:2011)
Zahnheilkunde - Zahnärztliche Behandlungsgeräte - Teil 1: Allgemeine Anforderungen
und Prüfverfahren (ISO 7494-1:2011)
Médecine bucco-dentaire - Units dentaires - Partie 1: Exigences et méthodes d'essai
générales (ISO 7494-1:2011)
Ta slovenski standard je istoveten z: EN ISO 7494-1:2011
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 7494-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7494-1:2011
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SIST EN ISO 7494-1:2011
EUROPEAN STANDARD
EN ISO 7494-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2011
ICS 11.060.20 Supersedes EN ISO 7494-1:2005
English Version
Dentistry - Dental units - Part 1: General requirements and test
methods (ISO 7494-1:2011)
Médecine bucco-dentaire - Units dentaires - Partie 1: Zahnheilkunde - Zahnärztliche Behandlungseinheiten - Teil
Exigences générales et méthodes d'essai (ISO 7494- 1: Allgemeine Anforderungen und Prüfverfahren (ISO 7494-
1:2011) 1:2011)
This European Standard was approved by CEN on 14 August 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 7494-1:2011: E
worldwide for CEN national Members.
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SIST EN ISO 7494-1:2011
EN ISO 7494-1:2011 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 7494-1:2011
EN ISO 7494-1:2011 (E)
Foreword
This document (EN ISO 7494-1:2011) 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 February 2012, and conflicting national standards shall be withdrawn
at the latest by February 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 7494-1:2005.
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 7494-1:2011 has been approved by CEN as a EN ISO 7494-1:2011 without any modification.
3
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SIST EN ISO 7494-1:2011
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SIST EN ISO 7494-1:2011
INTERNATIONAL ISO
STANDARD 7494-1
Second edition
2011-08-15
Dentistry — Dental units —
Part 1:
General requirements and test methods
Médecine bucco-dentaire — Units dentaires —
Partie 1: Exigences générales et méthodes d'essai
Reference number
ISO 7494-1:2011(E)
©
ISO 2011
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SIST EN ISO 7494-1:2011
ISO 7494-1:2011(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 7494-1:2011
ISO 7494-1:2011(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 7494-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 7494-1:2004), which has been technically
revised.
The following changes were made:
a) the requirements were aligned with IEC 60601-1:2005;
b) the mass distributions for the maximum loads were aligned with ISO 6875;
c) the requirements for the technical description and the labelling were updated.
ISO 7494 consists of the following parts, under the general title Dentistry — Dental units:
Part 1: General requirements and test methods
Part 2: Water and air supply
© ISO 2011 – All rights reserved iii
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SIST EN ISO 7494-1:2011
ISO 7494-1:2011(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 7494-1:2011
INTERNATIONAL STANDARD ISO 7494-1:2011(E)
Dentistry — Dental units —
Part 1:
General requirements and test methods
1 Scope
This part of ISO 7494 specifies requirements and test methods for dental units, regardless of whether or not
they are electrically powered.
It also specifies requirements for the manufacturer's instructions, 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 6875, Dentistry — Patient chair
ISO 9687, Dental equipment — Graphical symbols
ISO 11144, Dental equipment — Connections for supply and waste lines
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
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
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for basic safety and
1)
essential performance of dental equipment
1) To be published.
© ISO 2011 – All rights reserved 1
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SIST EN ISO 7494-1:2011
ISO 7494-1:2011(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given i
...
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