EN ISO 7492-2018 en Dentistry - Dental explorer.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry Dental explorer (ISO 7492:2018)BS EN ISO 7492:2018National forewordThis British Standard is the UK implementation of EN ISO 7492:2018. It is identical to ISO 7492:2018. It supersedes BS EN ISO 7492:1998, which

2、 is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on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 secretary.This publication does not purport to include all the necessary provi

3、sions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 87023 1ICS 11.060.25Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was publish

4、ed under the authority of the Standards Policy and Strategy Committee on 28 February 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 7492:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 7492February 2018ICS 11.060.20 Supersedes EN ISO 7492:199

5、8EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 7492:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members

6、Dentistry - Dental explorer (ISO 7492:2018)Mdecine bucco-dentaire - Sondes exploratrices dentaire (ISO 7492:2018)Zahnheilkunde - Zahnsonde (ISO 7492:2018)This European Standard was approved by CEN on 2 February 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stip

7、ulate 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 European S

8、tandard 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 are the n

9、ational 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, Romania,

10、Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 7492:2018 (E)European forewordThis document (EN ISO 7492:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the s

11、ecretariat 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 August 2018, and conflicting national standards shall be withdrawn at the latest by August 2018.Attention is draw

12、n to the possibility 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 7492:1998.According to the CEN-CENELEC Internal Regulations, the national standards organiz

13、ations 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, Luxembourg, Ma

14、lta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 7492:2018 has been approved by CEN as EN ISO 7492:2018 without any modification.2BS EN ISO 7492:2018ISO 7492:2018Foreword iv1 S

15、cope . 12 Normative references 13 Terms, definitions and symbols 13.1 Terms and definitions . 13.2 Symbols and abbreviated terms. 24 Requirements 34.1 Materials . 34.1.1 Material of the working end . 34.1.2 Material of the handle . 34.2 Location of measurement points . 34.3 Shape and dimensions 34.4

16、 Hardness of working tip 64.5 Connection between working end and handle 64.6 Surface finish 64.6.1 All surfaces 64.6.2 Surface finish of handle 64.7 Resistance to reprocessing . 65 Test methods . 75.1 Visual inspection . 75.2 Dimensions . 75.3 Hardness testing 75.4 Connection between working end and

17、 handle 75.4.1 Tensile load . 75.4.2 Torque . 75.5 Resistance to reprocessing . 76 Marking and labelling . 76.1 Labelling . 76.2 Marking . 8 ISO 2018 All rights reserved iiiContents PageBS EN ISO 7492:2018ISO 7492:2018ForewordISO (the International Organization for Standardization) is a worldwide fe

18、deration 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 committee has been established has the right to be represented on that com

19、mittee. 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 electrotechnical standardization.The procedures used to develop this document a

20、nd 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 drafted in accordance with the editorial rules of the ISO/IEC Directives, Pa

21、rt 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 rights. Details of any patent rights identified during the development of t

22、he 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 constitute an endorsement.For an explanation on the voluntary nature of standar

23、ds, 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) see the following URL: www.iso.org/iso/foreword.html.This document was prepare

24、d by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.This third edition cancels and replaces the second edition (ISO 7492:1997), which has been technically revised. The main changes compared to the previous edition are as follows:a) Reduction of forms by combination

25、of similar forms in one Figure (e. g Form A and Form B in Figure 2; Form C and Form D in Figure 3; Form E and Form F in Figure 4).b) Addition of new forms shown in Figure 7, Figure 8 and Figure 9;c) Addition of requirement for resistance to reprocessing.iv ISO 2018 All rights reservedBS EN ISO 7492:

26、2018Dentistry Dental explorer (ISO 7492:2018)1 ScopeThis document specifies the dimensions and performance requirements for dental explorers.This document is not applicable to endodontic explorers.2 Normative referencesThe following documents are referred to in the text in such a way that some or al

27、l of their content constitutes requirements 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, Dentistry VocabularyISO 6507-1, Metallic materials Vickers hardness t

28、est Part 1: Test methodISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test methodISO 7153-1, Surgical instruments Materials Part 1: MetalsISO 17664,Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices3 T

29、erms, definitions and symbols3.1 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 standardization at the following addresses: IEC Electropedia: available at https:/www.

30、electropedia.de ISO Online browsing platform: available at https:/www.iso.org/obp3.1.1dental explorerhandheld dental instrument with a pointed tip designed for tactile examination of tooth surfacesNote 1 to entry: See Figure 1.Note 2 to entry: Dental explorer is used to examine teeth for decay (cari

31、es), calculus, furcations, or other abnormalities. INTERNATIONAL STANDARD ISO 7492:2018 ISO 2018 All rights reserved 1BS EN ISO 7492:2018ISO 7492:2018Key1 handle2 shank3 working tip4 first bending point5 centreline6 datum pointh1working end heighth2shank heightFigure 1 Designation of parts and dimen

32、sions for dental explorers3.1.2datum pointsection point between the centreline of the handle, at right angle to the centreline, and the working tipNote 1 to entry: The datum point is where h1and h2meet.3.1.3handlearea used for holding the dental explorer (3.1.1) during tactile exploration3.1.4shankp

33、art of the dental explorer (3.1.1) that connects the working end to the handle3.1.5working endpart of the dental explorer (3.1.1) after the first bend of the shank including the working tipNote 1 to entry: The working end is the combination of h1and h2directly on the explorer.3.1.6working tipactive

34、part of the working end which will be first to contact the tooth surface3.2 Symbols and abbreviated termsFor the purposes of this document, the following symbols and abbreviated terms apply, and are shown in Figure 1 to Figure 9.b length of working tip (only used in Figure 5)h1working end heighth2sh

35、ank heightr working end radius2 ISO 2018 All rights reservedBS EN ISO 7492:2018ISO 7492:2018 working end angle secondary angle of working tip (only used in Figure 5)4 Requirements4.1 Materials4.1.1 Material of the working endThe working end of a dental explorer shall be made of metallic materials in

36、 accordance with ISO 7153-1.4.1.2 Material of the handleThe material for the handle, selected at the discretion of the manufacturer, shall meet the requirements of Clause 5.5.3 does not apply.4.2 Location of measurement pointsThe location of the points of measurement for dental explorers shall be as

37、 shown in Figure 1 and in Table 1.Table 1 Measurement of dimensions for dental explorersSymbol Meaning Points of measurementb Length of working tip (only used in Figure 5)distance from the extreme tip of the working end, parallel to the centre-line of the working tip, to the first bend of the workin

38、g endh1Working end height distance from the datum point, at right angles to the centreline of the shank, to the farthest extremity of the working tiph2Shank height distance from the datum point, at right angles to the centreline of the shank, to the furthest point on the external surface of the firs

39、t bend of the working endr Working end radius radius of curvature of the inside of the first bend of the working end Working end angle angle between the centreline of the shank and the working end Secondary angle of working tip (only used in Figure 5)angle between the centreline of the shank and a l

40、ine parallel to the tangent to the first bend of the working end4.3 Shape and dimensionsThe dental explorer shall have one of the forms shown in Figure 2 to Figure 9.Commonly used dimensions are shown in Table 2. The column is arranged according to the increase in the dimension h1.The dimensions sha

41、ll be measured in accordance with Table 1 and Figure 1.The working tip shall be pointed but the exact shape and design of the working end is left to the discretion of the manufacturer.The maximum length of a dental explorer shall be at the manufacturers discretion, but it should be noted that overal

42、l lengths in excess of 178 mm can cause difficulty in containment within a sterilization cassette. ISO 2018 All rights reserved 3BS EN ISO 7492:2018ISO 7492:2018Figure 2 Dental explorerFigure 3 Dental explorerFigure 4 Dental explorerFigure 5 Dental explorerFigure 6 Dental explorerFigure 7 Dental exp

43、lorer4 ISO 2018 All rights reservedBS EN ISO 7492:2018ISO 7492:2018Figure 8 Dental explorerFigure 9 Dental explorerTable 2 Dimensions of dental explorerLinear dimensions in millimetres Angular dimensions in degreesShape b0,5h10,5h20,5r0,51010Figure 2 1,5 9,0 6 90 2,0 9,0 6 70 2,5 7, 5 6 85 3,0 8,5 6

44、 90 4,2 3,8 4 85 Figure 3 6,3 4,0 1,5 40 7, 2 3,2 2,5 62 8,2 4,1 2,5 85 9,0 3,0 2 90 9,0 3,0 2 60 10,0 3,0 2 85 Figure 4 4,5 80 6,0 67 11,5 67 12,0 80 13,0 40 14,3 70 Figure 5 1,6 5,2 5,8 5 50 2601,6 6,5 5,8 5 50 1002,0 5,0 4,0 2 38 125Figure 6 4 11 25 5 4 55 5 12 25 6 11 35 7 8 40 11 11 45 11,5 8 5

45、5 ISO 2018 All rights reserved 5BS EN ISO 7492:2018ISO 7492:2018Shape b0,5h10,5h20,5r0,51010Figure 7 1,6 3,2 4 Figure 8 5,6 2,2 5 Figure 9 5,2 2,2 0,2 4.4 Hardness of working tipThe hardness of the working tip of the finished instrument shall be for:a) Martensitic stainless steel: 500 HV1 to 650 HV1

46、.b) Austenitic stainless steel: greater than 500 HV1.c) Cobalt-based alloys: greater than 500 HV1.Test the hardness in accordance with 5.3.4.5 Connection between working end and handleThe connection between working end and handle of the dental explorer shall not loosen under tensile test or torque.T

47、he connection between working end and handle shall meet at least a tensile force of 600 N and a torque of 0,45 Nm.Test the tensile strength in accordance with 5.4.1.Test the torque in accordance with 5.4.2.4.6 Surface finish4.6.1 All surfacesThe surface finish is at the discretion of the manufacture

48、r, but shall be visibly free from surface defects, e.g. pores, crevices, grinding marks, and from production residues, e.g. residual scale, acids, grease, remaining grinding and polishing material.Handle surface finishes should be able to be easily cleaned.Test in accordance with 5.1.4.6.2 Surface f

49、inish of handleThe mirror finish shall be both uniform and smooth with a highly reflective surface.Test in accordance with 5.1.4.7 Resistance to reprocessingDental explores shall withstand 100 reprocessing cycles, as defined by the manufacturers instructions, without deformation or showing signs of corrosion.There shall be no visible