EN ISO 7494-1-2011 en Dentistry - Dental units - Part 1 General requirements and test methods《牙科学 牙科综合治疗装置 第1部分 通用要求和试验方法》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 7494-1:2011Dentistry Dental unitsPart 1: General requirements and testmethods (ISO 7494-1:2011)BS EN ISO 7494-1:2011 BRITISH STANDARDNational forewordThis British Stand

2、ard is the UK implementation of EN ISO7494-1:2011. It supersedes BS EN ISO 7494-1:2005 which iswithdrawn.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 requ

3、est to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 68212 4ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Stand

4、ard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7494-1 August 2011 ICS 11.060.20 Supersedes EN ISO 7494-1:2005English Version Dentistry

5、- Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) Mdecine bucco-dentaire - Units dentaires - Partie 1: Exigences gnrales et mthodes dessai (ISO 7494-1:2011) Zahnheilkunde - Zahnrztliche Behandlungseinheiten - Teil 1: Allgemeine Anforderungen und Prfverfahren (ISO 7494-

6、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 bibliographi

7、cal 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

8、 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, Hun

9、gary, 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 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Cent

10、re: 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 7494-1:2011: EBS EN ISO 7494-1:2011EN ISO 7494-1:2011 (E) 3 Foreword This document (EN ISO 7494-1:2011) has been prepared by Technical C

11、ommittee 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 2

12、012, 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 rig

13、hts. 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,

14、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

15、7494-1:2011 without any modification. BS EN ISO 7494-1:2011ISO 7494-1:2011(E) ISO 2011 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is

16、 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

17、 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 pr

18、epare 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

19、 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 repl

20、aces 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

21、 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 BS EN ISO 7494-1:2011ISO 7494-1:2011(E) iv ISO 2011 All rights reservedIntroduction Specific qualitative and q

22、uantitative 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. BS EN ISO 7494-1:2011INTERNATIONAL STANDARD ISO 7494-1:2011(E) ISO 2011 A

23、ll rights reserved 1Dentistry 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 manufacturers instructio

24、ns, 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.

25、 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

26、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 eng

27、ineering 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 essential performance of dental equipment1)1) To be published.

28、 BS EN ISO 7494-1:2011ISO 7494-1:2011(E) 2 ISO 2011 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 60601-1 and IEC 80601-2-60 and the following apply. 3.1 dental equipment furniture, machines, apparatus and acc

29、essories made for use in the practice of dentistry and/or its associated procedures NOTE Adapted from ISO 1942:2009, definition 2.68. 3.2 dental unit combination of interconnected dental equipment and dental instruments constituting a functional assembly for use in the provision of dental treatment

30、ISO 1942:2009, definition 2.86 3.3 dental handpiece hand-held instrument used in dentistry for patient treatment, which is connected to the dental unit 3.4 high frequency surgery device HF surgery device electrosurgical device hand-held medical electrical instrument designed to transmit high frequen

31、cy electrical current to biological tissue for the purpose of cutting or modifying the tissue in a surgical procedure 4 Classification 4.1 General This classification applies to electrically operated dental units only. 4.2 According to type of protection against electric shock Dental units are class

32、ified 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 dental unit has an applied part, the applied part shall be grouped as Type B (see IE

33、C 60601-1:2005, 3.132). High frequency surgery devices incorporated in the dental unit are exempt from this classification. 4.4 According to mode of operation IEC 60601-1:2005, 6.6 applies. BS EN ISO 7494-1:2011ISO 7494-1:2011(E) ISO 2011 All rights reserved 35 Requirements 5.1 General Electrical re

34、quirements are only applicable to electrically operated dental units. There are, however, general requirements referred to in IEC 60601-1 which are applicable to non-electrical dental units as well. If a patient chair is an integral part of the dental unit, then ISO 6875 also applies. IEC 60601-1 an

35、d IEC 80601-2-60 apply. 5.1.1 Handpiece hoses Handpiece hoses connected to the dental unit shall be disconnectable for cleaning and disinfection. The disconnectability shall be checked by manual inspection. 5.1.2 Moving parts The requirements given in IEC 60601-1:2005, 9.2 apply. Testing shall be ca

36、rried 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 shall be in accordance with ISO 9687. IEC 60601-1:2005, 15.1 applies. 5.1.4 Usability Testing shall be carried out

37、 in accordance with IEC 62366. 5.1.5 Cleaning and disinfection All exterior parts, including cuspidor bowls and instrument hoses, shall be cleanable and disinfectable using agents recommended by the manufacturer without deterioration of the surface or markings. Testing shall be carried out in accord

38、ance with ISO 21530. 5.1.6 Excessive temperatures The requirements given in IEC 60601-1:2005, 11.1 apply. 5.1.7 Biocompatibility The requirements given in IEC 60601-1:2005, 11.7 apply. Compliance is checked by inspection of the information provided by the manufacturer. 5.1.8 Connections for supply a

39、nd waste lines All connections shall be in accordance with ISO 11144. BS EN ISO 7494-1:2011ISO 7494-1:2011(E) 4 ISO 2011 All rights reserved5.2 Mechanical requirements 5.2.1 Solids collector Dental units shall contain a solids collector in the waste system. The solids collector shall be capable of r

40、etaining solid particles with a diameter of 2 mm. Testing shall be carried out in accordance with 7.1. Measurement shall be carried out using readily available measuring instruments. 5.2.2 Amalgam separator device Dental units shall be capable of being equipped with or connected to an amalgam separa

41、tor device in the waste system. Testing shall be carried out in accordance with 7.1. 5.2.3 Bursting pressure Pressure systems used in dental units shall be strong enough to withstand, without bursting or leaking, the pressures specified in 7.2.2. Testing shall be carried out in accordance with 7.2.2

42、. 5.3 Electrical requirements IEC 60601-1 and IEC 80601-2-60 apply. 5.3.1 Failsafe device In case of a single-fault condition, e.g. failure of a limit switch, additional protective means (failsafe device) shall be provided. EXAMPLE Mechanical limits to prevent injury to the patient and/or operating

43、personnel. Testing shall be carried out in accordance with 7.3.1. 5.3.2 Test point In order to perform the service requirement specified in IEC 62353, the dental unit shall have a connector/plug for the power supply. Testing shall be carried out in accordance with 7.1. 6 Sampling Where possible, all

44、 type tests shall be made on one representative sample of the dental unit being tested. 7 Testing 7.1 Visual inspection Visually inspect the equipment to determine compliance with the requirements. BS EN ISO 7494-1:2011ISO 7494-1:2011(E) ISO 2011 All rights reserved 57.2 Mechanical tests 7.2.1 Movin

45、g parts Measure the distances between the moving parts and counterparts and visually inspect the equipment to determine compliance with the requirements. 7.2.2 Pressure vessels and parts subject to pneumatic and hydraulic pressure Test in accordance with IEC 60601-1:2005, 9.7. 7.3 Electrical tests I

46、EC 60601-1 and IEC 80601-2-60 apply. 7.3.1 Failsafe device On dental units which are power-activated and controlled by limit switches, deliberately bypass such limit switches one by one (single-fault condition). Then operate the test piece through its full range of motion to ensure that it does not

47、result in collapse of the test piece or damage to the test piece that would be harmful to the patient or to the operating personnel. 8 Manufacturers instructions 8.1 General Documents shall be provided containing at least the information specified in 8.2 to 8.3. IEC 60601-1: 2005, 7.9.1 applies. 8.2

48、 Instructions for use IEC 60601-1: 2005, 7.9.2 applies. In addition, the full range of motion shall be quoted. If mounting equipment for other manufacturers attachments is provided, the manufacturer shall stipulate the maximum loading capabilities for those attachments in the instructions for use in

49、cluded with each dental unit. 8.3 Technical description IEC 60601-1:2005, 7.9.3.1, 7.9.3.2 and 7.9.3.3 apply. In addition, the following information shall also be provided by the manufacturer: a) overall dimensions of the dental unit; b) overall dimensions of the baseplate and service location interfaces, if applicable; c) details of interface surfaces and methods of retention (bolts, etc.), electrical supplies and other services; d) information on the assembly and mounting of the dental unit; e) electrical