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1、BRITISH STANDARD BS EN ISO 1797-2:1995 Dental rotary instruments Shanks Part 2: Shanks made of plastics The European Standard EN ISO 1797-2:1995 has the status of a British Standard Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1
2、797-2:1995 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 August 1995 BSI 01-2000 The following BSI references relate to the work on this standard: Commit
3、tee reference HCC/52 Draft for comment 90/56943 DC ISBN 0 580 24559 4 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee HCC/52, Dental instruments, upon which the following bodies were represented: British Dental Associatio
4、n British Dental Trade Association British Endodontic Society British Society for Restorative Dentistry British Society for the Study of Prosthetic Dentistry Department of Health Ministry of Defence Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na,
5、Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1797-2:1995 BSI 01-2000i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Introduction3 1Scope3 2Normative references3 3Symbols and terms3 4Requirements4 5Test methods5 6Quality control5 Anne
6、x ZA (normative) Normative references to international publications with their relevant European publications6 Figure 1 Type 1 shank3 Figure 2 Type 2 and type 4 shank4 Figure 3 Type 3 shank4 Figure 4 Shank4 Figure 5 Flattened portions, cross-section B-B of Figure 45 List of referencesInside back cov
7、er Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1797-2:1995 ii BSI 01-2000 National foreword This Part of this British Standard has been prepared by Technical Committee HCC/52 and is the English language version of EN ISO 1797-2
8、:1995 Dental rotary instruments Shanks Part 2: Shanks made of plastics, published by the European Committee for Standardization (CEN). It is identical with ISO 1797-2:1992 published by the International Organization for Standardization (ISO). This Part of this British Standard, together with BS EN I
9、SO 1797-1:1995, constitutes a revision of BS 6828-1:1987 which is 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 conf
10、er immunity from legal obligations. Cross-references Publication referred toCorresponding British Standard ISO 1797-1:1992BS EN ISO 1797-1:1995 Specification for dental rotary instruments Shanks Part 1. Shanks made of metals EN ISO 3630-1:1990 (ISO 3630-1:1992) BS 6815 Dental root canal instruments
11、Part 1:1993 Specification for files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches EN 23630-2:1991 (ISO 3630-2:1986) BS EN 23630-2:1992 Dental root canal instruments Part 2. Specification for enlargers Summary of pages This document comprises a front cover, an inside
12、 front cover, pages i and ii, the EN ISO title page, pages 2 to 6, 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. Licensed Copy: sheffieldun
13、sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1797-2 February 1995 ICS 11.060.20 Descriptors: Dentistry, dental equipment, dental rotary-cutting instruments, burs(dental), plastic products, shanks, classificat
14、ion, specification, dimensions, dimensional measurements English version Dental rotary instruments Shanks Part 2: Shanks made of plastics (ISO 1797-2:1992) Instruments rotatifs dentaires Queues Partie 2: Queues en matires plastiques (ISO 1797-1:1992) Zahnrztliche rotierende Instrumente Schfte Teil 2
15、: Schfte aus Kunststoff (ISO 1797-2:1992) This European Standard was approved by CEN on 1995-01-12. 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-
16、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 official versions (English, French, German). A version in any other language made by translation unde
17、r 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, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherla
18、nds, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for 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
19、 any means reserved in all countries to CEN and its members Ref. No. EN ISO 1797-2:1995 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 1797-2:1995 BSI 01-2000 2 Foreword This European Standard has been taken over by Technical Commi
20、ttee CEN/TC 55, Dentistry, from the work of ISO/TC 106, Dentistry, of the International Standardization Organization (ISO). ISO 1797 consists of the following parts, under the general title Dental rotary instruments Shanks. Part 1: Shanks made of metals; Part 2: Shanks made of plastics. The text was
21、 submitted to the Updating Questionnaire Procedure (UQ) and approved as a European Standard. EN ISO 1797-1 together with EN ISO 1797-2 replaces EN 21797:1989. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the
22、 latest by August 1995, and conflicting national standards shall be withdrawn at the latest by August 1995. In accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ice
23、land, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. NOTENormative references to international publications are listed in Annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy
24、, (c) BSI EN ISO 1797-2:1995 BSI 01-20003 Introduction This International Standard is one of a series of basic standards on dental rotary instruments and constitutes an important link between the standards on dental rotary instruments and those on dental handpieces. 1 Scope This part of ISO 1797 spe
25、cifies shanks of dental rotary instruments made of plastics materials and gives measurement methods for the verification of the dimensions. A quality requirement is added in order to ensure a high quality level. Subclauses 4.6 and 4.7 do not apply to disposable (single-use) instruments. Shanks made
26、of plastics materials are designed for use at speeds less than 5 000 r/min. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 1797. At the time of publication, the editions indicated were valid. All stan
27、dards are subject to revision, and parties to agreements based on this part of ISO 1797 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO/R 527
28、:1966, Plastics Determination of tensile properties. ISO 1797-1:1992, Dental rotary instruments Shanks Part 1: Shanks made of metals. ISO 3274:1975, Instruments for the measurement of surface roughness by the profile method Contact (stylus) instruments of consecutive profile transformation Contact p
29、rofile meters, system M. ISO 3630-1:, Dental root-canal instruments Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches1). ISO 3630-2:1986, Dental root canal instruments Part 2: Enlargers. ISO 4288:1985, Rules and procedures for the measurement of surface ro
30、ughness using stylus instruments. 3 Symbols and terms Symbols and terms are shown in Figure 1 to Figure 3, with the following key: NOTE 1Figure 2 and Figure 3 are given for consistency with ISO 1797-1. 1) To be published. d1diameter of shank d2diameter in the groove sD-flat dimension l1fitting lengt
31、h l2shoulder to end length l3shoulder to groove length l4width of groove Figure 1 Type 1 shank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 1797-2:1995 4 BSI 01-2000 4 Requirements 4.1 Material Shanks shall be made of plastics mate
32、rials. The type of plastics and treatment are at the discretion of the manufacturer. 4.2 Dimensions The dimensions and tolerances shall be as shown in Figure 4 and Figure 5. 4.3 Surface irregularities Flattened portions Surface irregularities shall comply with the following specifications, which rel
33、ate to Figure 5: d1= 2,35 x = 0,04 max. d2u d1 4.4 Surface roughness The surface roughness within l1 shall be as specified in Figure 4. Testing shall be carried out in accordance with ISO 3274 and ISO 4288. 4.5 Tensile strength The tensile strength shall be a minimum of 84 N/mm2. Testing shall be ca
34、rried out in accordance with ISO/R 527. 4.6 Heat resistance and colour stability This requirement does not apply to disposable instruments. Shanks shall show no signs of deformation and there shall not be recognizable colour change after testing. Testing shall be carried out in accordance with 5.3.
35、Figure 2 Type 2 and type 4 shank Figure 3 Type 3 shank 0 0,05 Figure 4 Shank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 1797-2:1995 BSI 01-20005 4.7 Stability against swelling and chemicals This requirement does not apply to disp
36、osable instruments. Shanks shall not swell beyond the specified tolerance range of Figure 4 when treated with disinfecting or sterilizing solutions as recommended by the manufacturer. Shanks shall meet the tolerance range of Figure 4 when sterilized according to 5.3. Testing shall be carried out in
37、accordance with 5.1 and 5.2. 4.8 Colour code The colour of the plastic shanks shall comply with the colour code of the instrument for which it is used. For root-canal instruments, this shall meet the requirements of ISO 3630-1 and ISO 3630-2. Testing shall be carried out by visual inspection. 5 Test
38、 methods 5.1 Shank dimensions Measurements shall be made using either tungsten carbide ring gauges checked regularly with mating plugs, air gauges, or dial indicators, graduated in divisions of 0,001 mm. The diameter d1 shall apply over the length l1. 5.2 Other dimensions Measurements shall be made
39、using either appropriate gauges with tungsten carbide faces, tungsten carbide-faced micrometer calipers, toolmakers microscopes, or dial indicators. 5.3 Heat resistance, colour stability and stability against swelling and chemicals 5.3.1 Apparatus Steam autoclave and dry heat sterilizers. 5.3.2 Proc
40、edure Autoclave ten instruments of each size under pressure of 220 kPa (2,2 bar) at (136 2) C for 20 min and dry heat sterilize at (180 5) C for 120 min. 6 Quality control The specification of ISO 1797-1:1992, clause 8 for shanks of type 1 applies. Figure 5 Flattened portions, cross-section B-B of F
41、igure 4 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 1797-2:1995 6 BSI 01-2000 Annex ZA (normative) Normative references to international publications with their relevant European publications This European Standard incorporates by
42、 dated or undated reference, provisions from other publications. 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 Stand
43、ard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). PublicationYearTitleEN/HDYear ISO 3630-11992Dental root-canal instruments Part 1: Files, reamers, barbed broaches, rasps, paste carriers
44、, explorers and cotton broaches. EN ISO 3630-11990 ISO 3630-21986Dental root-canal instruments Part 2: Enlargers EN 23630-21991 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1797-2:1995 BSI 01-2000 List of references See national
45、 foreword. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:10:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1797-2:1995 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It
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