EN ISO 20608-2018 en Dentistry - Powder jet handpieces and powders.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Powder jet handpieces and powdersBS EN ISO 20608:2018National forewordThis British Standard is the UK implementation of EN ISO 20608:2018. It is identical to ISO 20608:2018.The UK participation in its prepar

2、ation 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 secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for i

3、ts correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 90419 6ICS 11.060.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy an

4、d Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 20608:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 20608May 2018ICS 11.060.20EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMI

5、TEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 20608:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry - Powder jet handpieces and powders (ISO 20608:2018)Mdecine bucco-dentaire

6、 - Poudres et pices main de pulvrisation (ISO 20608:2018)Zahnheilkunde - Pulverstrahl-Handstcke und Pulver (ISO 20608:2018)This European Standard was approved by CEN on 22 March 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving t

7、his 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

8、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 Austr

9、ia, 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, Slovenia, Spain

10、, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 20608:2018 (E)European forewordThis document (EN ISO 20608:2018) 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

11、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 November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Attention is drawn to the possibility that s

12、ome 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.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Eur

13、opean 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slov

14、akia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.2BS EN ISO 20608:2018ISO 20608:2018Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Classification of handpieces . 35 Requirements 35.1 Powder for powder jet handpieces . 35.1.1 General

15、35.1.2 Biocompatibility . 35.2 Powder jet handpieces . 45.2.1 General 45.2.2 Biocompatibility of materials . 45.2.3 Drop test 45.2.4 Noise level 45.2.5 Surfaces 45.2.6 Nozzle rotation 45.3 Air and water supply 45.3.1 Drive air . 45.3.2 Spray water . 55.4 Excessive air and water pressure 55.5 Tempera

16、ture 55.5.1 Maximum temperature during normal use 55.5.2 Applied parts not intended to supply heat to a patient 55.6 Vibrations 55.7 Resistance to reprocessing . 55.8 Leakage and/or ingress of water 55.9 Operating controls . 65.10 Usability 65.11 Connection 65.11.1 General 65.11.2 Connections 65.12

17、Backflow preventer . 65.13 Electrical safety 65.14 Test report . 76 Sampling 77 Measurement and test methods . 77.1 General test conditions 77.2 Visual inspection . 77.2.1 Visual inspection of equipment 77.2.2 Visual inspection of documentation or test reports 77.3 Drive air . 77.3.1 Apparatus . 77.

18、3.2 Procedure . 77.4 Spray water 77.4.1 Apparatus . 77.4.2 Procedure . 87.5 Air and water pressure 87.5.1 Apparatus . 87.5.2 Procedure . 87.6 Connection 87.6.1 Apparatus . 8 ISO 2018 All rights reserved iiiContents PageBS EN ISO 20608:2018ISO 20608:20187.6.2 Procedure . 87.7 Noise level . 87.7.1 App

19、aratus . 87.7.2 Test chamber . 87.7.3 Procedure . 87.8 Maximum temperature during normal use 97.9 Applied parts not intended to supply heat to a patient . 97.10 Resistance to reprocessing . 97.11 Backflow preventer . 98 Instructions for use, maintenance and service 108.1 Powder jet handpieces 108.2

20、Powder 119 Technical description .119.1 Powder jet handpiece . 119.2 Powder 1110 Marking and labelling 1110.1 General 1110.2 Powder jet handpieces 1210.3 Powders 1211 Packaging 12Annex A (informative) Example of a test report 13iv ISO 2018 All rights reservedBS EN ISO 20608:2018ISO 20608:2018Forewor

21、dISO (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

22、 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 elec

23、trotechnical 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. This document was

24、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 or all such patent

25、 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 users and does not con

26、stitute 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 to Trade (TBT) s

27、ee the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. ISO 2018 All rights reserved vBS EN ISO 20608:2018ISO 20608:2018IntroductionPowder jet handpieces have been used in applications and pro

28、cedures in the field of dentistry for many years.Technological developments continuously create better powder jet handpieces that are easier to handle, as well as the associated powders in use, for example for teeth cleaning. The correct combination of these elements is very important in order to ac

29、hieve a good clinical performancevi ISO 2018 All rights reservedBS EN ISO 20608:2018ISO 20608:2018 ISO 2018 All rights reserved viiBS EN ISO 20608:2018This page deliberately left blankDentistry - Powder jet handpieces and powders1 ScopeThis document specifies the general requirements, test methods,

30、manufacturers information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1).This document applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations

31、and plaque and to clean and polish teeth where abrasion is a side effect.It is also applicable to powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the remov

32、al of cement residues where abrasion is part of the desired outcome.This document is not applicable for the dental units that are employed to supply the powder jet handpieces.This document is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (sca

33、lers) or multifunctional handpieces (syringes).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. For undated references, the latest

34、 edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 5349-1, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirementsISO 5349-2, Mechanical vibration Measurement and evaluation of

35、human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplaceISO 7494-1, Dentistry Dental units Part 1: General requirements and test methodsISO 9168, Dentistry Hose connectors for air driven dental handpiecesISO 9687, Dentistry Graphical symbols for dental

36、 equipmentISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 11014, Safety data sheet for chemical products Content and order of sectionsISO 14971, Medical devices Application of risk management to medical devicesISO 15223-1, Medi

37、cal devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 17664, Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devicesISO 21531, Dentistry Graphi

38、cal symbols for dental instrumentsINTERNATIONAL STANDARD ISO 20608:2018 ISO 2018 All rights reserved 1BS EN ISO 20608:2018ISO 20608:2018IEC 60601-1:2005+AMD1: 2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 61672-1, Electroacoustics Sound

39、 level meters Part 1: SpecificationsIEC 62366-1, Medical devices Part 1: Application of usability engineering to medical devicesIEC 80601-2-60:2012, Medical electrical equipment Part 2-60: Particular requirements for basic safety and essential performance of dental equipment3 Terms and definitionsFo

40、r the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available

41、 at https:/www.iso.org./obp3.1abrasionremoval of material using a powder by grinding, scouring or spraying3.2powder jet handpiecedental handpiece designed to transfer powder to the patient, powered via a dental unit meeting the requirements of ISO 7494-1 or a dedicated dental unit according to the m

42、anufacturers discretion (e.g. table top control unit) Key1 powder jet handpiece2 handpiece nozzle3 hose connectorFigure 1 Powder jet handpiece3.2.1cleaning powder jet handpiecedental handpiece designed to transfer powder to the patient for tooth cleaning and polishing3.2.2abrasion powder jet handpie

43、cedental handpiece designed to transfer powder to the patient for abrasive dental treatment3.3powderdry material consisting of fine ground biocompatible substances intended for the cleaning, and polishing or abrasion of tooth surfaces in conjunction with a powder jet handpiece2 ISO 2018 All rights r

44、eservedBS EN ISO 20608:2018ISO 20608:20183.4spray waterwater that is used to suppress dust production and to wash away the powder3.5dental unitdevice (stationary or non-stationary) through which electrical power and/or various fluids or gasses are supplied to at least one or more dental handpieces a

45、nd devicesSOURCE: IEC 80601-2-60:2012,201.3.2063.6dental handpiecehandheld instrument used in dentistry for use in patient treatment and connected to the dental unitSOURCE: IEC 80601-2-60:2012,201.3.2034 Classification of handpiecesPowder jet handpieces are classified into two types according to the

46、ir scope of application, as given in Table 1.Table 1 Powder jet handpieces and powders according to scope of applicationNumber Type Common used powder substances1 Cleaning powder jet handpiece e.g. sodium hydrogen carbonate, sodium bicarbonate, calcium carbonate, glycine2 Abrasion powder jet handpie

47、ce e.g. corundum5 Requirements5.1 Powder for powder jet handpieces5.1.1 GeneralThe powders used in combination with powder jet handpieces shall ensure a safe and reliable operation and the efficacy of the system (powder and handpiece). The powders shall not present a hazard for the patient, the user

48、 or a third party when used in accordance with the manufacturers instructions. To ensure this the manufacturer shall provide suitable protection measures against aspiration or ingestion of the powder where either would be hazardous to the patient.IEC 62366-1 and ISO 14971 shall apply.Test conformity

49、 in accordance with 7.2.2 and by examination of the instructions for use of the powder.5.1.2 BiocompatibilityPowders used for powder jet handpieces shall be evaluated for biocompatibility meeting the requirements of ISO 10993-1.Test conformity in accordance with 7.2.2. ISO 2018 All rights reserved 3BS EN ISO 20608:2018ISO 20608:20185.2 Powder jet handpieces5.2.1 GeneralThe design of the powder jet handpieces in combination with the powder shall ensure a safe and reliable operation. The use and h