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1、BRITISH STANDARD BS EN ISO 15087-1:2001 Incorporating Corrigendum No. 1 Dental elevators Part 1: General requirements The European Standard EN ISO 15087-1:2001 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: she
2、ffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 15087-1:2001 This British Standard, having been prepared under the direction of the Health and Environmental Sector Policy and Strategy Committee, was published under the authority of the Standards Pol
3、icy and Strategy Committee on 18 September 2001 BSI 29 January 2002 ISBN 0 580 38058 0 National foreword This British Standard is the official English language version of EN ISO 15087-1:2001. It is identical with ISO 15087-1:1999. The UK participation in its preparation was entrusted to Technical Co
4、mmittee CH/52, Dental instruments, which has the responsibility to: 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 publications referred to in this document may be fou
5、nd 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 necessary provisions of a contract. Users of British Standard
6、s are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for chang
7、e, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii and iii, a blank
8、page, pages 1 to 11, the Annex ZA page, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 13635 Incorporating Corrigendum No. 1 29 January 2002 Corrected the
9、EN ISO foreword page and inserted the Annex ZA page. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15087-1 August 2001 ICS 11.060.20 English version Dental elevators - Part 1: Genera
10、l requirements (ISO 15087- 1:1999) Elvateurs dentaires - Partie 1: Exigences gnrales (ISO 15087-1:1999) Zahnrztliche Wurzelheber - Teil 1: Allgemeine Anforderungen (ISO 15087-1:1999) This European Standard was approved by CEN on 11 June 2001. CEN members are bound to comply with the CEN/CENELEC Inte
11、rnal 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 on application to the Management Centre or to any CEN member.
12、 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 Management Centre has the same status as the official versions. CEN members are
13、the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROP
14、ISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15087-1:2001 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006,
15、 Uncontrolled Copy, (c) BSI CORRECTED 2001-12-05 Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Dentistry“ of the International Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 55 “Dentistry“, the s
16、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 February 2002, and conflicting national standards shall be withdrawn at the latest by February 2002. According t
17、o the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spai
18、n, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 15087-1:1999 has been approved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 150871:
19、2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI A Reference number ISO 15087-1:1999(E) INTERNATIONAL STANDARD ISO 15087-1 First edition 1999-11-01 Dental elevators Part 1: General requirements lvateurs dentaires Partie 1: Exigences gnra
20、les EN ISO 150871:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Contents 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification2 5 Material .2 6 Requirements.2 7 Test methods3 8 Marking.4 Annex A (informative)
21、 Measurement of dimensions5 Annex B (informative) Vickers hardness testing7 Annex C (informative) Test under tensile load.9 Annex D (informative) Test under torque10 EN ISO 150871:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Fore
22、word 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 techn
23、ical 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 of
24、electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requi
25、res approval by at least 75 % of the member bodies casting a vote. International Standard ISO 15087-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. ISO 15087 consists of the following parts, under the general title Dental elevators: Part 1: General
26、 requirements Part 2: Warwick James elevators Part 3: Cryer elevators Part 4: Coupland elevators Part 5: Bein elevators Part 6: Flohr elevators Annexes A to D of this part of ISO 15087 are for information only. EN ISO 150871:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00
27、:00 2006, Uncontrolled Copy, (c) BSI EN ISO 150871:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DRADNATS LANOITANRETNI OSI)E(9991:1-78051 OSI 1 Dental elevators Part 1: General requirements 1 Scope This part of ISO 15087 specifies th
28、e general material and performance requirements for dental elevators. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 15087. For dated references, subsequent amendments to, or revisions of, a
29、ny of these publications do not apply. However, parties to agreements based on this part of ISO 15087 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document re
30、ferred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1942-3:1989, Dental vocabulary Part 3: Dental instruments. ISO 2592, Petroleum products Determination of flash and fire points Cleveland open cup method. ISO 3104, Petroleum products Transpar
31、ent and opaque liquids Determination of kinematic viscosity and calculation of dynamic viscosity. ISO 6507-1:1997, Metallic materials Vickers hardness test Part 1: Test method. ISO 7153-1:1991, Surgical instruments Metallic materials Part 1: Stainless steel. ISO 13402, Surgical and dental hand instr
32、uments Determination of resistance against autoclaving, corrosion and thermal exposure. 3 Terms and definitions For the purposes of this part of ISO 15087, the terms and definitions given in ISO 1942-3 apply. EN ISO 150871:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:0
33、0 2006, Uncontrolled Copy, (c) BSI )E(9991:1-78051 OSI OSI 2 4 Classification Dental elevators specified in all parts of ISO 15087 are classified according to the Vickers hardness of the working end into the following classes: Class 1: 480 HV 1 to 600 HV 1 Class 2: 600 HV 1 to 720 HV 1 The manufactu
34、rer shall state the Vickers classification in the product documentation. 5 Material 5.1 Material of the working end The working end shall be made of martensitic stainless steel of grade B, C, D or R complying with ISO 7153-1, or other materials providing the instrument made therefrom meets the requi
35、rements of clause 6. 5.2 Material of the handle The material of the handle, selected at the discretion of the manufacturer, shall meet the requirements of clause 6. 6 Requirements 6.1 Maximum overall length Unless otherwise specified in other parts of ISO 15087, the maximum overall length of dental
36、elevators shall be 178 mm. Annex A provides details of one method of measurement applicable to most types of dental elevators. 6.2 Vickers hardness of the working end The Vickers hardness of the working end of the finished instrument, when tested in accordance with ISO 6507-1, shall be within the ra
37、nge of class 1 or class 2. The manufacturer shall state the appropriate hardness class for each instrument pattern or range of instruments in the product documentation. Annex B provides details of a method of measurement for Vickers hardness. 6.3 Surface finish 6.3.1 All surfaces All surfaces shall
38、be visibly free from pores, crevices, grinding marks, residual scales, acid, grease and residual grinding and polishing materials, when inspected using normal vision. 6.3.2 Satin finish Any satin finish shall be both uniform and smooth, and it shall reduce glare. 6.3.3 Mirror finish Any mirror finis
39、h shall be ground to remove all surface imperfections and polished to remove grinding marks, resulting in a highly reflective surface. 6.4 Resistance against autoclaving When tested in accordance with 7.2, the instrument shall exhibit no visible signs of alteration. EN ISO 150871:2001 Licensed Copy:
40、 sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI OSI)E(9991:1-78051 OSI 3 6.5 Resistance against corrosion 6.5.1 Working end When tested for resistance to boiling water in accordance with 7.3, the working end shall exhibit no visible signs of corrosion. 6.
41、5.2 Handle When tested for resistance to boiling water in accordance with 7.3, the handle shall exhibit no visible signs of corrosion. 6.6 Resistance against thermal exposure When tested for resistance against thermal exposure in accordance with 7.3, the instrument shall exhibit no visible signs of
42、alteration. 6.7 Union between the working end and handle The union between the working end and the handle of the instrument, previously tested in accordance with 6.3 to 6.6, shall not become loosened under tensile load when tested in accordance with 7.4.1 and under torque when tested in accordance w
43、ith 7.4.2. 6.8 Hollow-handle leak test When tested in accordance with 7.5.1 or 7.5.2, the instrument handle shall emit no bubbles which are a sign of leakage. 7 Test methods 7.1 Test sequence and cycles Carry out one of the following testing alternatives in one continuous operation for five cycles:
44、a) autoclave test or b) boiling water test and thermal exposure test. After completing the test (7.2 or 7.3), rub the instrument vigorously with a cloth to remove blemishes. NOTE Instruments with hollow handles, when subject to the combination of boiling water and thermal exposure tests, may rupture
45、 from the expansion of trapped moisture. 7.2 Autoclave test Carry out the autoclave test as specified in ISO 13402. 7.3 Boiling water test and thermal exposure test Carry out both the boiling water test and the thermal exposure test as specified in ISO 13402. 7.4 Test for union between working end a
46、nd handle 7.4.1 Test under tensile load Subject the union between the working end and the handle to a tensile force of 1000 N, applied in the direction parallel to the centreline of the handle, for a duration of at least 5 s. Annex C describes a suitable test procedure. EN ISO 150871:2001 Licensed C
47、opy: sheffieldun sheffieldun, na, Fri Nov 17 09:53:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI )E(9991:1-78051 OSI OSI 4 7.4.2 Test under torque Subject the union between the working end and the handle to a torque of 500 N cm for a duration of at least 5 s. Annex D describes a suitable test proced
48、ure. 7.5 Hollow-handle leak test 7.5.1 Heated oil test 7.5.1.1 Apparatus 7.5.1.1.1 Heat-resistant vessel. 7.5.1.1.2 Light oil, of minimum flash point 220 C in accordance with ISO 2592 and nominal kinematic viscosity of 16,5 mm2/s at 100 C in accordance with ISO 3104. 7.5.1.2 Procedure Put the light
49、oil into the heat-resistant vessel. Heat the oil to (180 5) C and then completely immerse the elevator handle in the oil for 2 min. No air bubbles shall be emitted during this test. 7.5.2 Ultrasonic test 7.5.2.1 Apparatus 7.5.2.1.1 Ultrasonic cleaning apparatus. 7.5.2.1.2 Basket made of wire net. 7.5.2.2 Procedure Align the dental elevators in a basket (7.5.2.1.2). Put the basket in an ultrasonic cleaning apparatus (7.5.2.1.1) filled with water at (40 2) C. Shake the basket carefully by hand and observe