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1、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 gnrales Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NAS
2、A Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15087-1:1999(E) ISO 1999 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by a
3、ny means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case postale 56 CH-1211 Genve 20 Switzerland Internetisoiso.ch Printed in Switzerland ii Contents 1 Scope1 2 Normative references
4、1 3 Terms and definitions .1 4 Classification2 5 Material .2 6 Requirements.2 7 Test methods3 8 Marking.4 Annex A (informative) Measurement of dimensions5 Annex B (informative) Vickers hardness testing7 Annex C (informative) Test under tensile load.9 Annex D (informative) Test under torque10 Copyrig
5、ht International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 15087-1:1999(E) iii Foreword ISO (the Internati
6、onal 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 technical committee has been
7、 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 electrotechnical standa
8、rdization. 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 requires approval by at leas
9、t 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 requirements Part 2: W
10、arwick 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. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Te
11、chnical Standards 1/9972545001 Not for Resale, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale,
12、04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISOISO 15087-1:1999(E) 1 Dental elevators Part 1: General requirements 1 Scope This part of ISO 15087 specifies the general material and performance requirements for dental elevators.
13、 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, any of these publications do not apply. However, parties to agreements
14、 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 referred to applies. Members of ISO and IEC maintain registers of curre
15、ntly 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 Transparent and opaque liquids Determination of kinematic viscosity and calcu
16、lation 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 instruments Determination of resistance against autoclaving, corrosion and
17、 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. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 0
18、4/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15087-1:1999(E) ISO 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
19、 1 to 600 HV 1 Class 2: 600 HV 1 to 720 HV 1 The manufacturer 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 materia
20、ls providing the instrument made therefrom meets the requirements 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
21、 parts of ISO 15087, the maximum overall length of dental 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 te
22、sted in accordance with ISO 6507-1, shall be within the range 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.
23、 6.3 Surface finish 6.3.1 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. 6.3.2 Satin finish Any satin finish shall be both uniform and smooth, and i
24、t shall reduce glare. 6.3.3 Mirror finish Any mirror finish 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 visi
25、ble signs of alteration. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 15087-1:1999(E)
26、 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. 6.5.2 Handle When tested for resistance to boiling water in accordance with 7.3, the handle shall exhibit no visible
27、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 alteration. 6.7 Union between the working end and handle The union between the working end and the handle of the in
28、strument, 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 with 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 e
29、mit 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: a) autoclave test or b) boiling water test and thermal exposure test. After completing the test (7.2 or 7.3), rub t
30、he 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 from the expansion of trapped moisture. 7.2 Autoclave test Carry out the autoclave test as specified in ISO 13402.
31、 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 and handle 7.4.1 Test under tensile load Subject the union between the working end and the handle to a tensile force
32、 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. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 N
33、ot for Resale, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15087-1:1999(E) ISO 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
34、 test procedure. 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 Pu
35、t the light 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
36、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 the appearance of the handles. If air bubbles immediately emerge from the handl
37、e surfaces, there are large-size pinholes in the handle. Sink the basket slowly to the bottom, leave it for 3 min and observe again whether air bubbles emerge from the handle surfaces. NOTE After a long time, air bubbles formed from air dissolved in water may adhere to the handle surfaces. Neglect t
38、hem. Subsequently put the basket in an ultrasonic cleaning apparatus under running water at (70 2) C for 5 min. The running water will remove any air bubbles adhering to the surface. If the emergence of such air bubbles is observed, there are very small size pinholes in the handle. 8 Marking The ins
39、trument shall be indelibly marked with the following information: a) manufacturers name or trade name; b) pattern number or name; c) lot number. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resa
40、le, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 15087-1:1999(E) 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 optica
41、l 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 technique available. A.2 Apparatus A.2.1 Optical projector (shadowgraph
42、) fitted with a 103 magnifying lens and micrometer stage. A.2.2 Glass specimen slide and plasticine, or A.2.3 Mechanical holding device (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
43、in A.2.2, A.2.3 or A.2.4. A.3.1.2 Place the supported instrument on the micrometer stage of the projector (A.2.1) and ensure that the following 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 unobstruct
44、ed view of the working end. A.3.1.3 Ensure that the dental instrument is parallel to the micrometer stage by focusing on, and traversing 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
45、in focus, repeat A.3.1.2 and A.3.1.3 until the handle remains in focus through the field of traverse. A.3.1.4 Align the centreline of the dental instrument with the vertical or horizontal cross-wires on the projector screen. Copyright International Organization for Standardization Provided by IHS un
46、der license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 02:22:47 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15087-1:1999(E) ISO 6 A.3.2 Horizontal and vertical measurements A.3.2.1 Refer to the illustration, table of dimension
47、s and table of measurement points related to the instrument to be measured and, using the micrometer stage, bring the 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 micromet
48、er and move the micrometer stage to the final measurement position and record the measurement. A.3.2.3 Realign the instrument (A.3.1.4) and repeat steps A.3.2.1 and A.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 app