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 It supersedes BS EN ISO 6875:2011 and BS EN ISO 74941:2011, which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on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.

25、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

26、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 user

27、s 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 ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers

28、 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 74941 cancels and replaces ISO 74941:2011 and ISO 6875:2011, which has been technically revised.

29、A list of all parts in the ISO 7494 series can be found on the ISO website. ISO 2018 All rights reserved vBS EN ISO 74941:2018This page deliberately left blankDentistry - Stationary dental units and dental patient chairs Part 1: General requirements1 ScopeThis document specifies requirements and tes

30、t 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.Operators stools, por

31、table dental equipment and operating lights are not in the scope of this document.2 Normative referencesThe 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.

32、 For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 4073, Dentistry Information system on the location of dental equipment in the working area of the oral health care providerISO 74942, Dentistry Dental units Par

33、t 2: Air, water, suction and wastewater systemsISO 81911, Furniture Assessment of the ignitability of upholstered furniture Part 1: Ignition source: smouldering cigaretteISO 9168, Dentistry Hose connectors for air driven dental handpiecesISO 109931, Biological evaluation of medical devices Part 1: E

34、valuation and testing within a risk management processISO 11143, Dentistry Amalgam separatorsISO 17664, Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devicesISO 21530, Dentistry Materials used for dental equipment surfa

35、ces Determination of resistance to chemical disinfectantsIEC 606011:2005+AMD1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 623661, Medical devices Part 1: Application of usability engineering to medical devicesIEC 62353, Medical electr

36、ical equipment Recurrent test and test after repair of medical electrical equipmentIEC 80601260:2012, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipmentINTERNATIONAL STANDARD ISO 7494-1:2018 ISO 2018 All rights reserved 1BS

37、EN ISO 74941:2018ISO 7494-1:20183 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 606011:2005 + AMD1:2012 and IEC 80601260:2012 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the f

38、ollowing addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1dental unitassembly of devices designed to provide utilities and amenities for dental treatment, such as compressed air, water or other liquids, suction,

39、 electricity, hand or footactivated controllers, work surfaces, tray supports, cuspidor, and gasses3.2dental patient chairdevice designed to support and position the patient for treatment and therefore provided with a range of movements3.3dental handpiecehandheld instrument used in dentistry for use

40、 in patient treatment and connected to the dental unit (3.1)SOURCE: IEC 80601260:2012, 201.3.2034 ClassificationClassification according to IEC 60601-1:2005 + AMD1:2012 and IEC 80601-2-60:2012 shall apply.5 Requirements5.1 General requirements5.1.1 Basic safety and essential performanceIEC 606011:20

41、05 + AMD1:2012 and IEC 80601260:2012 shall apply to dental units, to electrical dental patient chairs and to nonelectrical dental patient chairs.Conformity shall be checked in accordance with IEC 606011:2005 + AMD1:2012 and IEC 80601260:2012.5.1.2 Controls and indicatorsControls and indicators shall

42、 be designed and located to minimize accidental activation. For arrangement of controls and indicators IEC 606011:2005 + 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 606011:200

43、5 + AMD1:2012.5.1.3 Function stop systemElectrically 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 2 ISO 2018 All rights reservedBS EN ISO 74941:201

44、8ISO 7494-1:2018stops 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 c

45、arried out in accordance with 7.3.2.5.1.4 UsabilityUsability evaluation shall be carried out following the process described in IEC 623661.Testing shall be carried out in accordance with IEC 623661.5.1.5 Cleaning and disinfectionAll materials used for external and touchable surfaces of the dental un

46、it 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 recomm

47、ended by the manufacturer.Testing shall be carried out in accordance with ISO 21530.5.1.6 Excessive temperaturesIEC 606011:2005 + AMD1:2012, 11.1 and IEC 80601260:2012, 201.11 shall apply.Testing shall be carried out in accordance with IEC 606011:2005 + AMD1:2012 and IEC 80601260:2012.5.1.7 Biocompa

48、tibilityISO 109931 shall apply.Biocompatibility shall be assessed in accordance with ISO 109931.5.1.8 Solids filterDental 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 ou

49、t in accordance with 7.2.1.5.1.9 Amalgam separator deviceIf 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 padding5.1.10.1 Resistance to liquid absorptionCovering upholstery materials shall be resistant to liquid absorption.Testing shall be carried out in accordance with 7.1.1.5.1.10.2 Flammabi