EN ISO 6875-2011 en Dentistry - Patient chair《牙科学 牙科病人椅》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 6875:2011Dentistry Patient chair (ISO6875:2011)BS EN ISO 6875:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 6875:2011.I

2、t supersedes BS EN ISO 6875:1997 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purpor

3、t to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68377 0ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards

4、 Policy and Strategy Committee on 31 July 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 6875 July 2011 ICS 11.060.20 Supersedes EN ISO 6875:1996English Version Dentistry - Patient chair (ISO 6875:2011) Mdecine bucco-dentaire - Faut

5、euil dentaire (ISO 6875:2011) Zahnheilkunde - Patientenstuhl (ISO/FDIS 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 nat

6、ional 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 ve

7、rsion 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,

8、 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 COMIT

9、 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 6875:2011: EBS EN ISO 6875:2011EN ISO 6875:2011 (E) 3 Foreword T

10、his 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 a

11、n 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 b

12、e 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, C

13、roatia, 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 te

14、xt of ISO 6875:2011 has been approved by CEN as a EN ISO 6875:2011 without any modification. BS EN ISO 6875:2011ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards i

15、s 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 par

16、t 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 pre

17、pare 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 s

18、ome 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 th

19、e 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

20、provide for a mass of more than 135 kg;c) the requirements for the technical description and the labelling were updated.ISO 6875:2011(E) ISO 2011 All rights reserved iiiBS EN ISO 6875:2011IntroductionSpecific qualitative and quantitative test methods for freedom from biological hazard are not includ

21、ed in this International Standard. However, it is recommended that, for the assessment of possible biological hazards, reference be made to ISO 10993-1.ISO 6875:2011(E)iv ISO 2011 All rights reservedBS EN ISO 6875:2011INTERNATIONAL STANDARD ISO 6875:2011(E)Dentistry Patient chair1 ScopeThis Internat

22、ional 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, manufacturers information, markin

23、g and packaging.2 Normative referencesThe 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, De

24、ntistry VocabularyISO 4073, Dentistry Information system on the location of dental equipment in the working area of the oral health care providerISO 8191-1, Furniture Assessment of the ignitability of upholstered furniture Part 1: Ignition source: smouldering cigaretteISO 9687, Dental equipment Grap

25、hical symbolsISO 21530, Dentistry Materials used for dental equipment surfaces Determination of resistance to chemical disinfectantsISO/IEC 80601-2-60:2011, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipmentIEC 60601-1:2005,

26、 Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 62366, Medical devices Application of usability engineering to medical devicesIEC 62353, Medical electrical equipment Recurrent test and test after repair of medical electrical equipment3 Terms a

27、nd definitionsFor 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.3.1patient chairdevice equipped with a range of movements, designed to support and position the patient for dental treatment4 Classificat

28、ion4.1 GeneralThis classification applies to electrically operated patient chairs only. ISO 2011 All rights reserved 1BS EN ISO 6875:20114.2 According to type of protection against electric shockPatient chairs are classified in accordance with IEC 60601-1 as follows:a) Class I equipment, see IEC 606

29、01-1:2005, 3.13.b) Class II equipment, see IEC 60601-1:2005, 3.14.4.3 According to degree of protection against electric shockIf 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 operationIEC 60601-1:2005, 6.6 applies.NOTE Pati

30、ent chairs are intended for non-continuous operation.5 Requirements5.1 General requirements5.1.1 Electrical requirementsElectrical 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

31、-electrical patient chairs.IEC 60601-1 and ISO/IEC 80601-2-60 apply.5.1.2 Moving partsIEC 60601-1:2005, 9.2 applies.Testing shall be carried out in accordance with 7.2.1.5.1.3 Operating controlsOperating controls shall be designed and located to minimize accidental activation. Graphical symbols for

32、operating controls and performance shall be in accordance with ISO 9687.IEC 60601-1:2005, 15.1 applies.5.1.4 UsabilityTesting shall be carried out in accordance with IEC 62366.5.1.5 Function stop systemThe patient chair shall incorporate at least one function stop system which is located so that it

33、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.I

34、SO 6875:2011(E)2 ISO 2011 All rights reservedBS EN ISO 6875:20115.1.6 Upholstery and padding5.1.6.1 Resistance to liquid absorptionCovering upholstery materials shall be resistant to liquid absorption.Testing shall be carried out in accordance with 7.1.Covering materials that are suitable for cleani

35、ng and disinfection with agents recommended by the manufacturer shall be used. Such covering materials shall be resistant to these agents.Testing shall be carried out in accordance with ISO 21530.5.1.6.2 FlammabilityThe upholstery and padding shall not catch fire and resultant charring, if any, shal

36、l be not greater in length than 30 mm in any direction measured from the nearest point of the test cigarette.Testing shall be carried out in accordance with ISO 8191-1.5.1.7 Cleaning and disinfectionIt shall be possible to clean and disinfect all exterior parts of the patient chair using agents reco

37、mmended by the manufacturer without causing deterioration of the surface or markings.Testing shall be carried out in accordance with ISO 21530.5.1.8 Excessive temperaturesIEC 60601-1:2005, 11.1 applies.5.2 Mechanical requirements5.2.1 GeneralIEC 60601-1:2005, 9.1 and 9.8, and ISO/IEC 80601-2-60:2011

38、, 201.9 apply. The total patient weight shall be specified by the manufacturer in the instructions for use. The patient chair shall be capable of withstanding a patient weight of at least 135 kg.Table 1 Mass distribution in percentage of the total patient weight specified by the manufacturerPart of

39、patient supported by patient chairMass distribution%Minimum mass distributionkghead and neck 7,4 10upper trunk and upper arms 33,4 45lower trunk, lower arms and hands, thighs40,7 55legs and feet 18,5 25total patient 100 1355.2.2 Headrest constructionThe headrest shall be capable of withstanding, wit

40、hout failure and without risk to the patient or personnel, the force specified in 7.2.2. This force simulates unintentional movements and the weight of the patients head, including any additional load applied by the operator and the force imparted to the headrest by the patient due to arching of his

41、/her body.ISO 6875:2011(E) ISO 2011 All rights reserved 3BS EN ISO 6875:2011Testing shall be carried out in accordance with 7.2.2.5.2.3 ArmrestsArmrests, if provided, shall be capable of withstanding, without failure or permanent deformation, the force specified in 7.2.3. Armrests designed to be mov

42、able horizontally or vertically shall be capable of withstanding the loads specified in 7.2.3 without their function becoming permanently impaired.Testing shall be carried out in accordance with 7.2.3.5.2.4 Loading capacity5.2.4.1 Vertical liftPatient chairs shall be capable of supporting and liftin

43、g a mass of at least that given in 5.2.1 distributed according to Table 1, plus the movable mass of additional mounted dental equipment, plus the accessory devices, specified by the manufacturer as additional lifting capability. The patient chair shall not sink more than 10 mm in 1 h.Testing shall b

44、e carried out in accordance with 7.2.4.5.2.4.2 Static loadingPatient chairs have to be positioned in the most unfavourable position.Testing shall be carried out in accordance with IEC 60601-1:2005, 9.8 and ISO/IEC 80601-2-60:2011, 201.9.5.2.4.3 Tipping and stabilityThe base edge of the patient chair

45、 shall not tip or lift off the ground when either loaded or unloaded during the full backrest, seat, legrest and longitudinal adjustment motions, and after applying an additional mass as specified in 7.2.4.Testing shall be carried out in accordance with 7.2.5.5.2.5 Bursting pressurePressure systems

46、used in patient chairs shall be strong enough to withstand, without bursting or leaking, the pressure specified in 7.2.6.Testing shall be carried out in accordance with 7.2.6.5.3 Electrical requirements5.3.1 GeneralIEC 60601-1 and ISO/IEC 80601-2-60 apply.5.3.2 Failsafe deviceIn case of a single-fau

47、lt condition, e.g. failure of a limit switch, additional protective means shall be provided such as mechanical limits to prevent injury to the patient or operating personnel.Testing shall be carried out in accordance with 7.3.1.5.3.3 Test pointIn order to simplify safety tests specified in IEC 62353

48、, the patient chair shall have a connector for the mains power supply.ISO 6875:2011(E)4 ISO 2011 All rights reservedBS EN ISO 6875:2011Testing shall be carried out in accordance with 7.1.6 SamplingWhere possible, all type tests shall be made on one representative sample of the patient chair.7 Testin

49、g7.1 Visual inspectionVisually inspect the test piece to determine compliance with the requirements.7.2 Mechanical tests7.2.1 Moving partsMeasure the distances between the moving parts and counterparts and visually inspect the test piece to determine compliance with the requirements.7.2.2 Headrest constructionUse a circular metal disc of 100 mm diameter and with a radius of 15 mm at the edges.Place the test piece in the fully reclined position with the headrest fully extended. Apply the metal disc with a force of 7,4 % of the pati