EN ISO 7494-1-2018 Dentistry - Stationary dental units and dental patient chairs - Part 1 General requirements.pdf
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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Stationary dental units and dental patient chairsPart 1: General requirementsBS EN ISO 74941:2018National forewordThis British Standard is the UK implementation of EN ISO 74941:2018. It is identical to ISO 7
2、4941:2018. It supersedes BS EN ISO 6875:2011 and BS EN ISO 74941:2011, which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained on request to its s
3、ecretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 92085 1ICS 11.060.20Compliance with a British Standard can
4、not confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 74941:2018EUROPEAN STANDARDNORME EUROPENNEEUROPI
5、SCHE NORMEN ISO 7494-1July 2018ICS 11.060.20 Supersedes EN ISO 6875:2011, EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 74941:2018: EAll rights of exploitatio
6、n in any form and by any means reserved worldwide for CEN national MembersDentistry Stationary dental units and dental patient chairs Part 1: General requirements (ISO 74941:2018)Mdecine buccodentaire Units dentaires fixes et fauteuils dentaires patient - Partie 1: Exigences gnrales (ISO 74941:2018)
7、Zahnheilkunde Fest installierte Behandlungseinheiten und Patientensthle Teil 1: Allgemeine Anforderungen und Prfverfahren (ISO 74941:2018)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
8、 for giving this European Standard the status of a national standard without any alteration. Uptodate lists and bibliographical references concerning such national standards may be obtained on application to the CENCENELEC Management Centre or to any CEN member.This European Standard exists in three
9、 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 bodie
10、s 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, Slove
11、nia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 7494-1:2018 (E)European forewordThis document (EN ISO 74941:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
12、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 possibili
13、ty 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 74941:2011.According to the CENCENELEC Internal Regulations, the national standards
14、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, Luxembo
15、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 7494-1:2018 has been approved by CEN as EN ISO 7494-1:2018 without any modification.iiBS EN ISO 74941:2018ISO 7494-1:201
16、8Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 24 Classification 25 Requirements 25.1 General requirements . 25.1.1 Basic safety and essential performance . 25.1.2 Controls and indicators 25.1.3 Function stop system . 25.1.4 Usability . 35.1.5 Cleaning and disinfection . 35.
17、1.6 Excessive temperatures . 35.1.7 Biocompatibility . 35.1.8 Solids filter 35.1.9 Amalgam separator device 35.1.10 Upholstery and padding 35.1.11 Air, water suction and waste water systems 45.2 Mechanical requirements 45.2.1 General mechanical requirements 45.2.2 Mechanical requirements for dental
18、units 45.2.3 Mechanical requirements for dental patient chairs 45.3 Electrical requirements . 65.3.1 General electrical requirements . 65.3.2 Test points for periodic safety checks . 65.3.3 Position limiting of dental patient chair 65.4 Test report . 66 Sampling 67 Testing . 67.1 Visual inspection .
19、 67.1.1 Visual inspection of device 67.1.2 Visual inspection of documentation or test reports 67.2 Mechanical tests . 77.2.1 Measurement of solids filter 77.2.2 Pressure vessels and parts subject to pneumatic or hydraulic pressure 77.2.3 Headrest of dental patient chair . 77.2.4 Armrest of dental pa
20、tient chair . 77.2.5 Vertical lift of dental patient chair 77.2.6 Tipping and stability of dental patient chair . 77.3 Electrical tests . 87.3.1 Position limiting of dental patient chair 87.3.2 Function stop system . 88 Manufacturers instructions . 98.1 General . 98.2 Instructions for use . 98.3 Tec
21、hnical description 99 Marking .109.1 Product marking . 109.2 Marking of packaging . 1010 Packaging 10 ISO 2018 All rights reserved iiiContents PageBS EN ISO 74941:2018ISO 7494-1:2018Annex A (informative) Example of a test report 12Bibliography .18iv ISO 2018 All rights reservedBS EN ISO 74941:2018IS
22、O 7494-1:2018ForewordISO (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 f
23、or which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on
24、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.
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