EN ISO 19715-2017 en Dentistry - Filling instrument with contra angle.pdf

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1、Dentistry Filling instrument with contra angleBS EN ISO 19715:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 19715:2017. It is identical to ISO 19715:2017. The UK participation in its prep

2、aration was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee 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

3、contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 86883 2ICS 11.060.20Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under th

4、e authority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 19715:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 19715May 2017ICS 11.060.20EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT E

5、UROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 19715:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry - Filling instrument with contra an

6、gle (ISO 19715:2017)Mdecine bucco-dentaire - Instrument dobturation double angulation (ISO 19715:2017)Zahnheilkunde - Fllinstrumente mit Kontrawinkel (ISO 19715:2017)This European Standard was approved by CEN on 1 March 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations w

7、hich stipulate the conditions for giving this 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 E

8、uropean Standard exists in three 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

9、are the national standards bodies 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,

10、Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 19715:2017 (E)European forewordThis document (EN ISO 19715:2017) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Denti

11、stry” 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 November 2017 and conflicting national standards shall be withdrawn at the latest by November 2017.Att

12、ention 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 rights.According to the CEN-CENELEC Internal Regulations, the national standards organizations of

13、 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, Luxembourg, Malta, Neth

14、erlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 19715:2017 has been approved by CEN as EN ISO 19715:2017 without any modification.iiBS EN ISO 19715:2017ISO 19715:2017(E)Foreword ivIntr

15、oduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 45.1 Dimensions . 45.2 Dimensions of working end . 45.3 Materials . 55.4 Surface finish 55.5 Handle. 55.6 Designation and combination of working ends 55.7 Resistance to reprocessing . 56 Measurem

16、ent and test methods . 66.1 Dimensions . 66.2 Hardness testing 66.3 Surface roughness inspection 66.4 Resistance to reprocessing test 67 Marking 6Annex A (informative) Designation and combinations of working ends 7Bibliography 9 ISO 2017 All rights reserved iiiContents PageBS EN ISO 19715:2017ISO 19

17、715:2017(E)ForewordISO (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

18、 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 in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on a

19、ll 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. T

20、his 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 o

21、r 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 users

22、 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

23、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 4, Dental instruments.iv ISO 2017 All rights reservedBS EN ISO 19715:2017ISO 19715:2017(E)IntroductionIn dentistry, corresponding to their inte

24、nded use, filling instruments come into contact with the patient. Consequently, special attention is to be given in respect to (re)processing.Consideration of ergonomic aspects is also required. This is supported by the specific contra angle design. ISO 2017 All rights reserved vBS EN ISO 19715:2017

25、This page deliberately left blankDentistry Filling instrument with contra angle1 ScopeThis document specifies requirements and test methods for a filling instrument with contra angle, which is used for the restoration of teeth via the application of polymer-based restorative materials and cements. I

26、t also specifies requirements for the design, dimensions and marking.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

27、references, the latest edition of the referenced document (including any amendments) applies.ISO 1942 , Dentistry VocabularyISO 6507-1 , Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1 , Metallic materials Rockwell hardness test Part 1: Test methodISO 17664 , Sterilization of

28、medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices3 Terms and definitionsFor 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 st

29、andardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1filling instrumentnon-active hand-guided dental instrument for applying and modelling polymer-based restorative materials and cemen

30、ts during dental restoration procedures3.2contra angleangle of the second bend of the shank that connects the handle to the working end (3.4) and that compensates the first bend so that the working end is in line with the axis of the shankEXAMPLE See Figure 1.3.3filling instrument with contra anglef

31、illing instrument (3.1), in which the working end (3.4) and the handle axis are on one axis and the shank forms a contra angle (3.2) EXAMPLE See Figure 1.INTERNATIONAL STANDARD ISO 19715:2017(E) ISO 2017 All rights reserved 1BS EN ISO 19715:2017ISO 19715:2017(E)3.4working endmost frontal area of the

32、 filling instrument (3.1) which is used for workingEXAMPLE See Figure 1.Key1 handle2 first bend of the shank3 second bend of the shank4 working endFigure 1 Design of filling instrument with contra angle4 ClassificationFilling instruments with contra angles are classified into the following types acc

33、ording to the design of the working end: Type A: Ball corresponding to Figure 2; Type B: Pear corresponding to Figure 3; Type C: Plane plugger corresponding to Figure 4 or Figure 5; Type D: Spatula, curved over edge corresponding to Figure 6; Type E: Spatula, curved over surface (beaver tail) corres

34、ponding to Figure 7.Figure 2 Type A: BallFigure 3 Type B: Pear2 ISO 2017 All rights reservedBS EN ISO 19715:2017ISO 19715:2017(E)Figure 4 Type C: Plane plugger, cylindricalFigure 5 Type C: Plane plugger, taperedFigure 6 Type D: Spatula, bended over edgeaFrontal view of enlargement X.Figure 7 Type E:

35、 Spatula, bended over surface (beaver tail) ISO 2017 All rights reserved 3BS EN ISO 19715:2017ISO 19715:2017(E)5 Requirements5.1 DimensionsThe dimensions shown in Figure 8 are recommended dimensions for filling instruments with contra angle. Other dimensions may be used at the manufacturers discreti

36、on.Single-ended filling instruments are also possible.Test in accordance with 6.1.Dimensions in millimetresKey first bend angle, 135 contra angle, 90NOTE This example shows the combination of working ends Type A Type A.Figure 8 Dimensions for filling instruments with contra angle 5.2 Dimensions of w

37、orking endWorking ends of filling instruments with contra angles shall satisfy the dimensions indicated in Table 1 and Table 2.The diameter for Type A shall be: min. 0,8 mm, max. 3,5 mm.The diameter for Type B shall be: min. 0,8 mm, max. 2,5 mm.The diameter for Type C shall be: min. 0,8 mm, max. 2,5

38、 mm.The diameter for Type D shall be: min 1,0 mm, max. 3,2 mm.The diameter for Type E shall be: min. 1,0 mm, max. 3,2 mm.Table 1 Examples for dimensions for working end of type A, type B and type CType DesignationDiameter, d 0,1 mmType A Ball 0,8 1,0 1,2 1,6 2,0 2,5 3,2 3,5Type B Pear 0,8 1,0 1,2 1,

39、6 2,0 2,5 Type C Plane plugger 0,8 1,0 1,2 1,6 2,0 2,5 4 ISO 2017 All rights reservedBS EN ISO 19715:2017ISO 19715:2017(E)Table 2 Examples for dimensions for working end of type D and type EType DesignationWidth, b 0,1 mmType D Spatula, edge 1,0 1,5 2,0 2,5 3,2Type E Spatula, surface (beaver tail) 1

40、,0 1,5 2,0 2,5 3,2Test in accordance with 6.1.5.3 MaterialsThe material of both the handle and the working tip is at the manufacturers discretion provided that the requirements of this document are met. If stainless steel is the material of choice, examples of suitable steel types can be found in IS

41、O 7153-1 .The stainless steel of the filling instrument shall have a hardness of 42 HRC to 60 HRC.Test in accordance with 6.2.5.4 Surface finishThe working ends of the filling instrument shall be polished with a surface roughness, R a, not exceeding 0,4 m, except where otherwise designed. The surfac

42、e can be gloss or matte, at the manufacturers discretion. All surfaces of the filling instrument shall be free of any surface defects and residues.Coatings may be added to the working tip of metal filling instruments to increase lubricity and provide contrast in the oral cavity.Test in accordance wi

43、th 6.3.5.5 HandleThe shape of the handle (e.g. circular, octagonal) is left to the discretion of the manufacturer.5.6 Designation and combination of working endsThe designation and combination of the working ends is described in Annex A.5.7 Resistance to reprocessingThe filling instrument shall with

44、stand 100 reprocessing cycles, as defined by the manufacturers instructions, in accordance with ISO 17664 without visible signs of distortion, deterioration in performance, or signs of corrosion.Non-metallic filling instruments shall withstand the same reprocessing materials as metallic filling inst

45、ruments, unless:a) the filling instrument is designated as single-use disposable item;b) the manufacturer has specified a maximum number of cycles less than 100. This number shall be used for the test.The reprocessing cycle shall include the recommended methods of cleaning, disinfection and, if reco

46、mmended by the manufacturer, sterilization.Test in accordance with 6.4. ISO 2017 All rights reserved 5BS EN ISO 19715:2017ISO 19715:2017(E)6 Measurement and test methods6.1 DimensionsMeasure the dimensions using a device that is accurate to 1/10 of the tolerance to be measured.NOTE Example of suitab

47、le measuring devices are vernier calipers and micrometers in accordance with ISO 3611 .6.2 Hardness testingCarry out hardness testing in accordance with ISO 6508-1 , scale C or ISO 6507-1 .6.3 Surface roughness inspectionMeasure the surface roughness, R a, by using a profilometer or calibrated refer

48、ence plates by probing at the central point that is 1 mm in linear distance from the working end of the instrument.6.4 Resistance to reprocessing testCarry out 100 reprocessing cycles with the filling instrument, as defined by the manufacturers instructions, in accordance with ISO 17664 .If the manu

49、facturer has specified a maximum number of cycles less than 100, this number shall be used for the test.Inspect the filling instrument for signs of deterioration, distortion or corrosion.NOTE Discolorations due to water stains are not signs of corrosion.7 MarkingFilling instruments with contra angle shall be indelibly marked with the following information:a) name of the manufacturer and/or trade name;b) model number (reference number);c) lot number (batch designation).6 ISO 2017 A