ISO-23317-2007.pdf
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1、 Reference number ISO 23317:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 23317 First edition 2007-06-15 Implants for surgery In vitro evaluation for apatite-forming ability of implant materials Implants chirurgicaux valuation in vitro de la capacit de formation dapatite des matriaux dimplants Copyrig
2、ht International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=DAWSON, DAVIS Not for Resale, 07/03/2007 02:02:59 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 23317:2007(E) PDF disclaimer This PDF file
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6、07 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, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the cou
7、ntry 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 Published in Switzerland ii ISO 2007 All rights reserved Copyright International Organization for Standardization Provided by IHS under l
8、icense with ISO Licensee=IHS Employees/1111111001, User=DAWSON, DAVIS Not for Resale, 07/03/2007 02:02:59 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 23317:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative refe
9、rences. 1 3 Terms and definitions. 1 4 Apparatus 2 5 Test specimen. 2 5.1 Specimen configuration and size 2 5.2 Specimen preparation 3 6 Simulated body fluid. 3 6.1 General. 3 6.2 Reagents for SBF 3 6.3 Ion concentrations and pH of SBF 3 6.4 Preparation of SBF . 4 6.5 Confirmation of ion concentrati
10、on of SBF. 6 6.6 Preservation of SBF 6 7 Procedure 6 8 Test report . 8 Annex A (informative) Apparatus for preparing SBF 9 Annex B (informative) Preparation of standard glasses for evaluating apatite-forming ability. 10 Bibliography. 12 Copyright International Organization for Standardization Provid
11、ed by IHS under license with ISO Licensee=IHS Employees/1111111001, User=DAWSON, DAVIS Not for Resale, 07/03/2007 02:02:59 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 23317:2007(E) iv ISO 2007 All rights reserved Foreword ISO (the International Organization for Stan
12、dardization) 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 established has the right
13、 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 standardization. International S
14、tandards 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 International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an
15、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 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 23
16、317 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=DAWSON, DAVIS Not for Resale, 07/03/2007 02:02:59 MDTNo repr
17、oduction or networking permitted without license from IHS -,-,- ISO 23317:2007(E) ISO 2007 All rights reserved v Introduction It has been revealed that materials of various kinds bind to living bone through a layer of apatite. It has been shown that this apatite layer can be reproduced on their surf
18、aces in an acellular and protein-free simulated body fluid (SBF) with ion concentrations nearly equal to those of human blood plasma, and that apatite thus formed is very similar to the bone mineral in its composition and structure. This evaluation of apatite-forming ability on implant material in S
19、BF is useful for evaluating its in vivo bone- bonding ability preliminary to animal experiments. When a bioactive material is implanted in a living body, a thin layer rich in Ca and P forms on its surface. The material then connects to the living tissue through this apatite layer without a distinct
20、boundary. It has been shown that this apatite layer can be reproduced on the surfaces of materials in SBF as well, and that apatite thus formed is very similar to bone mineral in its composition and structure. As bioactivity increases, apatite forms on the material surface in a shorter time in propo
21、rtion to this increase. The formation of apatite layers can be detected by thin film X-ray diffraction spectrometry and/or scanning electron microscopy. NOTE 1 The material which forms apatite on its surface in vivo can bond to living bone, since this apatite is biologically active. Their in vivo ap
22、atite deposition can be reproduced on their surfaces even in vitro in SBF. For example, in vivo calcification on surfaces of Bioglass, CaO-SiO2 glasses, Na2O-CaO-SiO2 glasses, CeraboneA-W, Ceravital-type glass-ceramic, sintered hydroxyapatite and alkali-heat-treated titanium metal, are correlated wi
23、th in vitro calcification in SBF. However, this does not exclude the possibility that materials, which do not form apatite on their surfaces in vivo, bond to living bone. For example, it is reported that such resorbable materials as beta-tricalcium phosphate (Ca3(PO4)2) and calcium carbonate bond to
24、 living bone without forming an apatite layer on their surfaces. NOTE 2 It has been reported that glasses with different compositions in the system Na2O-CaO-SiO2 show a correlation between bone-forming ability of materials implanted into a bone defect of a rabbit and apatite-forming ability on its s
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