EN ISO 7492-1998 en Dental Explorers《牙科用探针》.pdf

1、BRITISH STANDARD BS EN ISO 7492:1998 Incorporating Amendment No. 1 to BS ISO7492:1997 (which renumbers theBS ISO as BSENISO7492: 1998) Dental explorers ICS 11.060.20BSENISO7492:1998 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublishe

2、d underthe authorityof the Standards Boardand comes intoeffect on 15 September1997 BSI 05-1999 ISBN 0 580 28493 X National foreword This British Standard is the English language version of EN ISO7492:1998. It is identical with ISO7492:1997. It partly supersedes BS2965:1970 which has been withdrawn.

3、The UK participation in its preparation was entrusted to Technical Committee CH/52, Dental instruments, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and

4、 keep the UK interests, informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European

5、 publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessar

6、y provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN ISO

7、 title page, page 2, the ISO title page, page ii, pages1 to9 and aback cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date Comme

8、nts 10134 September 1998 Indicated by a sideline in the marginBSENISO7492:1998 BSI 05-1999 i Contents Page National foreword Inside front cover Foreword 2 Foreword ii Text of ISO 7492 1ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7492 May 1998 ICS 11.060.20 Descriptors: See ISO d

9、ocument English version Dental explorers (ISO 7492:1997) Sondes exploratrices dentaires (ISO 7492:1997) Zahnrztliche Sonden (ISO 7492:1997) This European Standard was approved by CEN on1 May1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions

10、 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 Central Secretariat or to any CEN member. This European Standard exists in three offic

11、ial 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, B

12、elgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secret

13、ariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7492:1998 EENISO7492:1998 BSI 05-1999 2 Foreword The text of the International Standard from Technical Committee ISO/TC106, Dentist

14、ry, of the International Organization for Standardization (ISO) has been taken over as a European Standard by Technical Committee CEN/TC55, 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 identic

15、al text or by endorsement, at the latest by November1998, and conflicting national standards shall be withdrawn at the latest by November1998. According to CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard:

16、 Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsment notice The text of the International Standard ISO7492:1997 has been approved by CEN as a Europ

17、ean Standard without any modification. NOTENormative references to International Standards are listed inAnnex ZA (normative). Contents Page Foreword 2 1 Scope 1 2 Normative references 1 3 Definitions 1 4 Material 1 4.1 Material of the working end 1 4.2 Material of the handle 1 5 Requirements 1 5.1 S

18、urface finish 1 5.2 Vickers hardness and tensile strength oftheworking end 1 5.3 Resistance against corrosion 1 5.4 Resistance against thermal exposure 1 5.5 Union of working end and handle 2 5.6 Marking 2 6 Form and dimensions 2 7 Test methods 2 7.1 Visual inspection 2 7.2 Tests for heat and corros

19、ion resistance 2 7.3 Test for union of working end and handle 2 Annex A (informative) Measurement of dimensions 5 Annex B (informative) Vickers hardness testing 5 Annex C (informative) Tensile load test 6 Annex D (informative) Torque test 6 Annex E (informative) Designation and marking 9 Annex ZA (n

20、ormative) Normative references tointernational publications with their relevantEuropean publications 9 Figure 1 Forms of dental explorer 4 Figure D.1 Torque test 8 Table 1 Measurement of dental explorer dimensions (seeFigure 1) 2 Table 2 Dental explorers Dimensions 3BSENISO7492:1998 ii BSI 05-1999 F

21、oreword ISO (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 te

22、chnical 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

23、of electrotechnical standardization. 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 least75%of the member bodies casting a vote. International Standard ISO 7492 was pre

24、pared by Technical Committee ISO/TC106, Dentistry, Subcommittee SC4, Dental instruments. This second edition cancels and replaces the first edition (ISO7492:1983), of which it constitutes a technical revision. Annex A toAnnex E of this International Standard are for information only. Descriptors: De

25、ntistry, dental equipment, dental probes, specifications, dimensions, tests, marking.BSENISO7492:1998 BSI 05-1999 1 1 Scope This International Standard specifies the dimensions and performance requirements for dental explorers. 2 Normative references The following standards contain provisions which,

26、 through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of

27、 applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 1942-3:1989, Dental vocabulary Part3:Dental instruments. ISO 6507-1:, Metallic materials Vickers hardness test Part1: Test method 1) . ISO 71

28、53-1:1991, Instruments for surgery Metallic materials Part1: Stainless steel. ISO 13402:1995, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure. 3 Definitions For the purposes of this International Standard, the definition for the te

29、rm “dental explorer” stated in ISO1942-3 applies. 4 Material 4.1 Material of the working end Working ends shall be made of austenitic or martensitic stainless steel in accordance with ISO7153-1. NOTEOther materials may also be used, provided that the instruments made therefrom meet the requirements

30、of clause5. 4.2 Material of the handle The material of the handle, selected at the discretion of the manufacturer, shall meet the requirements of clause5. 5 Requirements 5.1 Surface finish 5.1.1 All surfaces All dental explorer surfaces shall be visibly free from pores, crevices, grinding marks, res

31、idual scale, acid, greases and residual grinding and polishing materials. Tests shall be carried out in accordance with7.1. 5.1.2 Satin finish The satin finish shall be both uniform and smooth, and it shall reduce glare. 5.1.3 Mirror finish The mirror finish shall be obtained by grinding to remove a

32、ll surface imperfections and by polishing to remove grind marks, resulting in a highly reflective surface. 5.2 Vickers hardness and tensile strength of the working end The Vickers hardness of the finished instrument when tested in accordance with ISO6507-1, shall be: Annex B andAnnex C describe meth

33、ods for the measurement of Vickers hardness and tensile strength, respectively. 5.3 Resistance against corrosion When the dental explorer is tested in accordance with7.2.1 or7.2.2 and7.1, there shall be no visible signs of corrosion. With the exception of serrated martensitic stainless steel handles

34、, any blemish shall be considered as evidence of corrosion. 5.4 Resistance against thermal exposure When the dental explorer is tested in accordance with7.2.3, there shall be no alteration in physical appearance; the hardness value (or, in the case of austenitic stainless steel, tensile strength) sh

35、all remain within the specified limits. Annex B andAnnex C describe methods for the measurement of Vickers hardness and tensile strength, respectively. 1) To be published. (Revision of ISO6507-1:1982, ISO6507-2:1983, ISO6507-3:1989, ISO409-1:1982, ISO409-2:1983 and ISO/DIS409-3) Martensitic stainles

36、s steel 500 HV1 to650 HV1 Cobalt-based alloys min. 480 HV1 Austenitic stainless steel min. 500 HV1 or min. 1 700 MNmm 2tensile strengthBSENISO7492:1998 2 BSI 05-1999 5.5 Union of working end and handle The union between the working end and the handle of the instrument, which has previously been subj

37、ected to the tests according to7.2.1 and7.2.2, shall not become loosened under tensile load when tested in accordance with7.3.1 and under torque when tested in accordance with7.3.2. 5.6 Marking The instruments shall be marked in a manner chosen at the discretion of the manufacturer. Annex E provides

38、 details of a proposed method for instrument designation (seealsoTable 2) and it is recommended that manufacturers mark their packaging and catalogues in the proposed manner. 6 Form and dimensions The explorers shall have one of the forms A to H shown inFigure 1 and the dimensions, measured in accor

39、dance withTable 1, as shown inTable 2. All linear dimensions shall be expressed in millimetres and all angular dimensions shall be expressed in degrees. Annex A provides details of one method of measurement applicable to most types of dental instrument. The maximum overall length, irrespective of th

40、e form of the instrument, shall be178 mm. 7 Test methods 7.1 Visual inspection Visually inspect, without magnification and at normal visual acuity, the surfaces to determine compliance with the requirements. 7.2 Tests for heat and corrosion resistance Carry out the autoclave test(7.2.1) or the boili

41、ng water test(7.2.2) and the thermal test(7.2.3), in one continuous operation for five cycles. After completion of the tests, the instrument(s) shall be rubbed vigorously with a cloth to remove blemishes. 7.2.1 Autoclave test The autoclave test shall be carried out as specified in ISO13402. 7.2.2 Bo

42、iling water test The boiling water test shall be carried out as specified in ISO13402. 7.2.3 Thermal test The thermal test shall be carried out as specified in ISO13402. 7.3 Test for union of working end and handle 7.3.1 Under tensile load Subject the union between the working end and handle to a te

43、nsile force of600 N, applied in the direction parallel to the centreline of the handle, for a duration of5 s. Annex C describes a suitable test procedure. 7.3.2 Under torque Subject the union between the working end and handle to a torque of45 Ncm for a duration of5 s. Annex D describes a suitable t

44、est procedure. Table 1 Measurement of dental explorer dimensions (seeFigure 1) Symbol Meaning Points of measurement b 3 Blade length distance from the extreme tip of the blade, parallel to the centreline of the blade, to the blade/shank interface h 1 Blade height distance from the datum point, at ri

45、ght angles to the centreline of the instrument, to the farthest extremity of the blade h 2 Shank height distance from the datum point, at right angles to the centreline of the instrument, to the farthest external surface of the first bend of the shank r 1 Radius of blade radius of curvature of the i

46、nside of the blade Blade angle angle between the centreline of the blade and the centreline of the instrument Offset angle angle between the centreline of the shank and a line, parallel to the centreline of the instrument, forming a tangent with the first bend of the instrumentBSENISO7492:1998 BSI 0

47、5-1999 3 Table 2 Dental explorers Dimensions Linear dimensions in millimetres Angular dimensions in degrees Form (designation) Dimensions r 1 b 3 0,5 5 h 1 0,5 h 2 0,5 5 A (= 010) 011 012 4 4 85 90 4,2 4,2 3,8 3,8 B (= 020) 021 022 6 6 85 90 2,5 1,5 7,5 9,0 C (= 030) 031 032 033 2 2,5 2 85 86 80 10,

48、0 8,2 9,0 3,0 4,1 3,0 D (= 040) 041 042 2 2,5 60 62 9,0 7,2 3,0 3,2 E (= 050) 051 052 67 80 6,0 4,5 F (= 060) 061 062 67 80 11,5 12,0 G (= 070) 071 2 2 125 5,0 4,0 38 H (= 080) 081 082 083 11 11 11 45 35 25 11 6 4 BSENISO7492:1998 4 BSI 05-1999 Figure 1 Forms of dental explorerBSENISO7492:1998 BSI 0

49、5-1999 5 Annex A (informative) Measurement of dimensions A.1 General This method of measurement is applicable to most types of dental hand instrument and is based on the use of an optical projector. Dimensions are measured parallel, and at right angles, to the centreline of the instrument and are constructed from a datum point at its working end. Although this is the preferred method, it is by no means the only t