BS ISO 13175-3-2013 Implants for surgery Calcium phosphates Hydroxyapatite and beta-tricalcium phosphate bone substitute《外科植入物 磷酸钙 羟磷灰石和β-磷酸三钙骨骼替代品》.pdf
《BS ISO 13175-3-2013 Implants for surgery Calcium phosphates Hydroxyapatite and beta-tricalcium phosphate bone substitute《外科植入物 磷酸钙 羟磷灰石和β-磷酸三钙骨骼替代品》.pdf》由会员分享,可在线阅读,更多相关《BS ISO 13175-3-2013 Implants for surgery Calcium phosphates Hydroxyapatite and beta-tricalcium phosphate bone substitute《外科植入物 磷酸钙 羟磷灰石和β-磷酸三钙骨骼替代品》.pdf(24页珍藏版)》请在麦多课文档分享上搜索。
1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 13175-3:2012Implants for surgery Calcium phosphatesPart 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutesBS ISO 13175-3:2012 BRITISH STANDARDNational forewo
2、rdThis British Standard is the UK implementation of ISO 13175-3:2012.The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publicati
3、on does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013 ISBN 978 0 580 71183 1 ICS 11.040.40 Compliance with a British Standard cannot confer immunity
4、 from legal obligationsThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2013.Amendments issued since publicationDate Text affectedBS ISO 13175-3:2012 ISO 2012Implants for surgery Calcium phosphates Part 3: Hydroxyapatite and beta-tric
5、alcium phosphate bone substitutesImplants chirurgicaux Phosphates de calcium Partie 3: Substituts osseux base dhydroxyapatite et de phosphate tricalcique btaINTERNATIONAL STANDARDISO13175-3First edition2012-10-01Reference numberISO 13175-3:2012(E)BS ISO 13175-3:2012ISO 13175-3:2012(E)ii ISO 2012 All
6、 rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2012All 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 a
7、t the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 13175-3:2012ISO 13175-3:2012(E) ISO 2012 All rights reserved ii
8、iContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms, definitions and symbols 13.1 Terms and definitions . 13.2 Symbols . 34 Requirements 34.1 Trace elements 34.2 Qualitative and quantitative determination of crystalline phases . 44.3 Form and shape 54.4 Porosity . 54.5
9、Dissolution and pH change . 64.6 Measurement of material mechanical strength 74.7 Test report 11Bibliography .13BS ISO 13175-3:2012ISO 13175-3:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
10、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 to be represented on that committee. International organizations, governmental and non-government
11、al, 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 Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main
12、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 International Standard requires approval by at least 75 % of the member bodies casting a vote.Attent
13、ion 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 13175-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materia
14、ls.ISO 13175 consists of the following parts, under the general title Implants for surgery Calcium phosphates: Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutesiv ISO 2012 All rights reservedBS ISO 13175-3:2012ISO 13175-3:2012(E)IntroductionHydroxyapatite and -tricalcium phosphat
15、e synthetic bone substitutes are now considered as an adequate alternative to autografts and allografts. Indeed, the synthetic origin of these devices guarantees that no transmittable disease will contaminate the patient. Moreover, hydroxyapatite and -tricalcium phosphate have been shown to be osteo
16、conductive which means that they will promote bone healing at the surface of the material if implanted in a bone site (see References 6 and 7). Biocompatibility of hydroxyapatite and -tricalcium phosphate is demonstrated by extensive literature (see Reference 8).The devices referred to in this part
17、of ISO 13175 are of three types: synthetic monophasic hydroxyapatite or -tricalcium phosphate bone substitutes and biphasic hydroxyapatite/-tricalcium phosphate bone substitutes. The hydroxyapatite/-tricalcium phosphate ratio influence the dissolution rate of the material: the higher the -tricalcium
18、 phosphate content, the higher the dissolution rate (see References 9 to 11).The healing process into the bone substitutes is not only related to the material osteoconductive potential, it is also related to the porosity structure (see References 12 to 16). It is necessary that macroporosities are l
19、arge enough and interconnected for bone ingrowth to take place into the whole volume of the implant. Porosities have also an influence on the resorption rate of the ceramic: the higher the number of microporosities, the higher the dissolution rate (see Reference 14).As bone substitutes are not inten
20、ded for bearing heavy loads, their mechanical properties are not essential. However, most of the time blocks have to be reshaped by the surgeon to fit the shape of the bone cavity. The bone substitute shall have sufficient mechanical properties to be machined. ISO 2012 All rights reserved vBS ISO 13
21、175-3:2012BS ISO 13175-3:2012Implants for surgery Calcium phosphates Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes1 ScopeThis part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic -tricalcium phosphate bone substitutes and biphasi
22、c hydroxyapatite/-tricalcium phosphate bone substitutes in the form of blocks or granules.This part of ISO 13175 is not applicable to cell-seeded bone void fillers, calcium phosphate cements or bone void fillers containing materials other than hydroxyapatite and -tricalcium phosphate.2 Normative ref
23、erencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 2591-1, Test sieving Part 1: Methods us
24、ing test sieves of woven wire cloth and perforated metal plateISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 13320, Particle size analysis Laser diffraction methods1)ISO 13383-1, Fine ceramics (advanced ceramics, advanced tech
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