BS EN ISO 13397-1-1996 Periodontal curettes dental scalers and excavators General requirements《牙周刮匙 牙刮除器和牙钻孔器 一般要求》.pdf

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1、BRITISHSTANDARD BS EN ISO 13397-1:1996 Periodontal curettes, dental scalers and excavators Part1: General requirements The European Standard EN ISO13397-1:1995 has the status of a BritishStandard ICS 11.060.20BSENISO13397-1:1996 This BritishStandard, having been prepared under the directionof the He

2、alth and Environment Sector Board, was published under the authority ofthe Standards Boardand comesinto effect on 15June1996 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference CH/52 Draft for comment 94/504196 DC ISBN 0 580 25683 9 Committees responsibl

3、e for this BritishStandard The preparation of this BritishStandard was entrusted to Technical Committee CH/52, Dental instruments, upon which the following bodies wererepresented: British Dental Association British Dental Trade Association British Endodontic Society British Society for Restorative D

4、entistry British Society for the Study of Prosthetic Dentistry Department of Health Ministry of Defence Amendments issued since publication Amd. No. Date CommentsBSENISO13397-1:1996 BSI 01-2000 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 1 Scope 3 2 Norm

5、ative references 3 3 Definitions 3 4 Classification 3 5 Material 3 6 Requirements 3 7 Test methods 4 Annex A (informative) Measurement of dimensions 5 Annex ZA (normative) Normative references to international publicationswiththeir relevant European publications 6 List of references Inside back cove

6、rBSENISO13397-1:1996 ii BSI 01-2000 National foreword This BritishStandard has been prepared by Technical Committee CH/52 and isthe English language version of EN ISO13397-1:1995 Periodontal curettes, dental scalers and excavators Part1: General requirements, published by theEuropean Committee for S

7、tandardization (CEN). It is identical with ISO13397-1:1995 published by the International Organization for Standardization (ISO). EN ISO13397-1 was produced as a result of international discussion in which the United Kingdom took an active part. BS EN ISO13397-1:1996 supersedes BS2965:1970 which is

8、withdrawn. A British Standard does not purport to include all the necessary 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. Cross-references Publication r

9、eferred to Corresponding BritishStandard EN21942-3:1993 (ISO1942-3:1989) BS EN21942 Dental vocabulary Part3:1994 Dental instruments ISO7153-1:1991 BS5194 Surgical instruments Part1:1991 Specification for stainless steel Summary of pages This document comprises a front cover, an inside front cover, p

10、agesi andii, theEN ISO title page, pages2 to6, an inside back cover and a back 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.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NOR

11、M EN ISO13397-1 December1995 ICS 11.060.20 Descriptors: Dentistry, dental equipment, dental instruments, classification, specifications, material specifications, performance, tests, generalities English version Periodontal curettes, dental scalers and excavators Part1: General requirements (ISO13397

12、-1:1995) Curettes parodontales, instruments dentaires pour dtartrage et excavateurs dentaires Partie1: Prescriptions gnrale (ISO13397-1:1995) Parodontalkretten, zahnrztliche Schaber und Exkavatoren Teil1: Allgemeine Anforderungen (ISO13397-1:1995) This European Standard was approved by CEN on1995-12

13、-06. 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 bibliographical references concerning such national standards may be obtained

14、 on application to the Central Secretariat 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 of a CEN member into its own language and notified to the Central Secretar

15、iat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee fo

16、r Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1995 All rights of reproduction and communication in any form and by any means reserved in all countries to CEN and its members Ref.No.ENISO13397-1:1995EENISO13397

17、-1:1995 BSI 01-2000 2 Foreword The text of the International Standard ISO13397-1:1995 has been prepared by Technical Committee ISO/TC106, Dentistry, in collaboration with CEN/TC55, Dentistry. ISO13397 consists of the following parts, under the general title Periodontal curettes, dental scalers and e

18、xcavators: Part1: General requirements; Part2: Periodontal curettes Gr-type (dimensions); Part3: Dental scalers H-type (dimensions); Part4: Dental excavators. It is anticipated that additional types of instruments will form the subject of future parts. Annex A of this part of ISO13397 is for informa

19、tion only. 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 June1996, and conflicting national standards shall be withdrawn at the latest by June1996. In accordance with the CEN/CENELEC Internal Re

20、gulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. NOTENormative references to international

21、publications are listed in Annex ZA (normative).ENISO13397-1:1995 BSI 01-2000 3 1 Scope This part of ISO13397 specifies the general material and performance requirements for periodontal curettes, dental scalers and excavators. 2 Normative references The following standards contain provisions which,

22、through reference in this text, constitute provisions of this part of ISO13397. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO13397 are encouraged to investigate the possibility of applying the

23、 most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO1942-3:1989, Dental vocabulary Part3:Dental instruments. ISO6507-2:1983, Metallic materials Hardness test Vickers test Part2: HV0,2 to less thanHV5. ISO715

24、3-1:1991, Surgical instruments Metallic materials Part1: Stainless steel. ISO13402:1995, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure. 3 Definitions For the purposes of this part of ISO13397, the definitions given in ISO1942-3 a

25、pply. 4 Classification Periodontal curettes, dental scalers and excavators specified in all parts of ISO13397 are classified according to the Vickers hardness of the working end: class1:600HV1700HV1 class2:550HV1620HV1 5 Material 5.1 Material of working end The working end shall be made of martensit

26、ic stainless steel complying with ISO7153-1 or other materials providing the instrument made therefrom meets the requirements of clause6. 5.2 Material of handle The material of the handle, selected at the discretion of the manufacturer, shall meet the requirements of clause6. 6 Requirements 6.1 Surf

27、ace finish 6.1.1 All surfaces All surfaces shall be visibly free from pores, crevices, grinding marks, residual scales, acid, grease and residual grinding and polishing materials, when inspected using normal vision. 6.1.2 Satin finish Satin finish shall be both uniform and smooth, and it shall reduc

28、e glare. 6.1.3 Mirror finish Mirror finish shall be ground to remove all surface imperfections and polished to remove grind marks, resulting in a highly reflective surface. 6.2 Vickers hardness of working end The Vickers hardness of the finished instrument, when tested in accordance with ISO6507-2,

29、shall be within the range of class1 or class2. The manufacturer shall state the appropriate(hardness) class for each instrument pattern or range of instruments in the documentation. 6.3 Resistance against corrosion When tested in accordance with7.2 or7.3, there shall be no visible signs of corrosion

30、. With the exception of serrated martensitic stainless steel handles, any blemish shall be considered as evidence of corrosion. 6.4 Resistance against thermal exposure When tested in accordance with7.4, there shall be no alteration of its physical appearance. The Vickers hardness after thermal expos

31、ure shall still be within the stipulated hardness range. 6.5 Union of working end and handle The union between the working end and the handle of the instrument, previously tested in accordance with7.1, shall not become loosened under tensile load when tested in accordance with7.5.1 and under torque

32、when tested in accordance with7.5.2. 6.6 Design and dimensions The instrument shall have the design and dimensions specified in the appropriate part ofISO13397. Annex A provides details of one method of measurement applicable to most types of dental hand instrument.ENISO13397-1:1995 4 BSI 01-2000 7

33、Test methods 7.1 Test sequence and cycles Carry out the autoclave test or the boiling water testand the thermal test in one operation for fivecycles. After completion of the tests rub the instrument(s) vigorously with a cloth to remove any blemishes. 7.2 Autoclave test Carry out the autoclave test a

34、s specified in ISO13402. 7.3 Boiling water test Carry out the boiling water test as specified inISO13402. 7.4 Thermal test Carry out the thermal test as specified in ISO13402. 7.5 Test for union of working end and handle 7.5.1 Test under tensile load Subject the union between the working end and the

35、 handle to a tensile force of600N, applied in the direction parallel to the centreline of the handle, for a duration of at least5s. 7.5.2 Test under torque Subject the union between the working end and the handle to a torque of400Ncm for a duration of at least5s.ENISO13397-1:1995 BSI 01-2000 5 Annex

36、 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

37、 a datum point at its working end. Although this is the preferred method, it is by no means the only technique available. A.2 Apparatus A.2.1 Optical projector (shadowgraph) fitted with 10 magnifying lens and micrometer stage. A.2.2 Glass specimen slide and plasticine, or A.2.3 Mechanical holding de

38、vice (e.g.light machine vice), or A.2.4 V-block A.3 Procedure A.3.1 Preparation for measurement A.3.1.1 Support or hold the dental instrument using one of the devices inA.2.2, A.2.3 orA.2.4. A.3.1.2 Place the supported instrument on the micrometer stage of the projector(A.2.1) and ensure that the fo

39、llowing requirements are met: a) the working end of the instrument projects beyond the holding device; b) the instrument is securely held; c) there is an unobstructed view of the working end. A.3.1.3 Ensure that the dental instrument is parallel to the micrometer stage by focussing on, and traversin

40、g the length of, the handle. If the handle remains in focus over the traversed distance, then the instrument is ready for measurement. If the handle does not remain in focus, repeatA.3.1.2 andA.3.1.3 until the handle remains in focus through the field of traverse. A.3.1.4 Align the centreline of the

41、 dental instrument with the vertical and horizontal cross-wires on the projector screen. A.3.2 Horizontal and vertical measurements A.3.2.1 Refer to the illustration, table of dimensions and table of measurement points related to the instrument to be measured and, using the micrometer stage, bring t

42、he appropriate point of the projected image to either the vertical or horizontal cross-wire, whichever is appropriate to the datum measuring point of interest. A.3.2.2 Zero the micrometer and move the micrometer stage to the final measurement position and record the measurement. A.3.2.3 Realign the

43、instrument(A.3.1.4) and repeat stepsA.3.2.1 andA.3.2.2 for the remaining dimensions. A.3.3 Angular measurements A.3.3.1 Refer to the illustration, table of dimensions and table of measurement points related to the instrument to be measured and, using the micrometer stage, bring the appropriate point

44、 of the projected image to either the vertical or horizontal cross-wire, whichever is appropriate. A.3.3.2 Rotate the bezel of the projector screen to the datum measuring point and note the angular reading. A.3.3.3 Rotate the bezel to the final measurement position, subtract the initial angular read

45、ing from the final reading and record the measured angle.ENISO13397-1:1995 6 BSI 01-2000 Annex ZA (normative) Normative references to international publications with their relevant European publications This European Standard incorporates by dated or undated reference, provisions from other publicat

46、ions. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision.

47、For undated references the latest edition of the publication referred to applies. Publication Year Title EN Year ISO1942-3 1989 Dental vocabulary Part3: Dental instruments EN21942-3 1993BSENISO13397-1:1996 BSI 01-2000 List of references Seenational foreword.BS EN ISO 13397-1:1996 BSI 389 Chiswick Hi

48、gh Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions BritishStandards are updated by amendmen

49、t or revision. Users of BritishStandards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this BritishStandard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel:02089969000. Fax:02089967400. BSI offers members an individual updating service called PLUS which ensur