ISO 16402-2008 Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics《外科植入物 丙烯酸树脂粘接剂 矫形外科用丙烯酸树脂粘接剂.pdf
《ISO 16402-2008 Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics《外科植入物 丙烯酸树脂粘接剂 矫形外科用丙烯酸树脂粘接剂.pdf》由会员分享,可在线阅读,更多相关《ISO 16402-2008 Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics《外科植入物 丙烯酸树脂粘接剂 矫形外科用丙烯酸树脂粘接剂.pdf(12页珍藏版)》请在麦多课文档分享上搜索。
1、INTERNATIONAL STANDARD ISO 16402 First edition 2008-05-15 Reference number ISO 16402:2008(E) ISO 2008 Implants for surgery Acrylic resin cement Flexural fatigue testing of acrylic resin cements used in orthopaedics Implants chirurgicaux Ciment base de rsine acrylique Essais de fatigue flexurale des
2、ciments base de rsine acrylique utiliss en orthopdieISO 16402:2008(E) ii ISO 2008 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are emb
3、edded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated
4、. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a pro
5、blem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, incl
6、uding photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Publis
7、hed in SwitzerlandISO 16402:2008(E) ISO 2008 All rights reserved iii Foreword 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 technic
8、al committees. Each member body interested in a subject for which a technical 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 wi
9、th the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft Inte
10、rnational Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document ma
11、y be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 16402 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials iv INTERNATIONAL STANDARD ISO 16402:2008(E) ISO 2008 All rights reserved 1
12、Implants for surgery Acrylic resin cement Flexural fatigue testing of acrylic resin cements used in orthopaedics 1S c o p e This International Standard applies to resin cements based on poly(methacrylic acid esters) and specifies the procedure for determining the fatigue behaviour of the polymerized
13、 cement. This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, on
14、ly the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5833:2002, Implants for surgery Acrylic resin cements ISO 16428, Implants for surgery Test solutions and environmental conditions for static and dynamic corrosi
15、on tests on implantable materials and medical devices 3 Test method The tests make use of rectangular bar-shaped test specimens. The method for preparing these specimens is described in Clause 5. The bending strength of the resulting test specimens is determined by means of a four-point bend test un
16、der quasi static and cyclic loading conditions. Under cyclic loading conditions two test methods are described. The first one follows the Whler method (S/N curve method) and determines the behaviour over the full range of stress levels. The second one (low stress method) determines the behaviour at
17、lower stress levels only. These lower stress levels, which are specified, are thought to correspond to stress levels expected to be encountered in clinical use. 4 Apparatus 4.1 Equipment for mixing cement, as recommended by the cement manufacturer. 4.2 Moulds, made of a suitable material to produce
18、rectangular bar-shaped specimens directly in their final shape with the dimensions of length, width and depth. If preferred, one or more moulds to produce plates of thickness may be used and the specimens subsequently cut to size using a saw. All surfaces of the moulds which come into contact with t
19、he cement shall be finely finished with 400 grade emery paper. NOTE Materials with sufficient stiffness, as for example aluminium alloys or stainless steel, have been found to be suitable. 4.3 Flat, smooth plates, (two for each mould) of a suitable material and size to cover the upper and lower surf
20、aces of the moulds (4.2). 75 mm 10 mm 3,3 mm 3,3 mmISO 16402:2008(E) 2 ISO 2008 All rights reserved 4.4 Mould release agent, to facilitate separation of the specimens from the moulds. NOTE Teflon-spray, vacuum grease or beeswax have been found to be suitable. 4.5 Polyester film, to cover the plates
21、of the mould. 4.6 C-clamp(s) or other device(s), for clamping the mould(s) between the top and bottom plates. 4.7 Bend test machine, capable of applying loads up to which optionally can increase linearly or can cycle sinusoidally over a range of loads between and the selected value at a frequency of
22、 , and which is equipped with a device for measuring, controlling and recording the load to an accuracy of . 4.8 Four-point bend test rig, having the dimensions shown in Figure 1 (corresponding to ISO 5833:2002, Annex F) with means of preventing initial misalignment, changes of alignment and walking
23、-off of the test specimen on the supports during the test. The loading points should be of the rolling type and have a diameter of . The test rig should be such that equal loads are applied to all loading points. 4.9 Water bath, to maintain the test specimen and the loading fixtures at a temperature
24、 of . 4.10 Saw. 4.11 Emery paper, 400 grade. 5 Preparation of test specimens 5.1 General conditions The mould(s) (4.2), plates (4.3), mixing equipment (4.1) and the cement to be used (both powder and liquid components) shall be maintained at for at least before casting the test specimen(s). The spec
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- ISO164022008IMPLANTSFORSURGERYACRYLICRESINCEMENTFLEXURALFATIGUETESTINGOFACRYLICRESINCEMENTSUSEDINORTHOPAEDICS

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