BS ISO 23317-2014 Implants for surgery In vitro evaluation for apatite-forming ability of implant materials《外科植入物 植入材料磷灰石形成能力的体外评估》.pdf

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1、BSI Standards PublicationBS ISO 23317:2014Implants for surgery In vitroevaluation for apatite-formingability of implant materialsBS ISO 23317:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 23317:2014. It supersedes BS ISO 23317:2012 which is withdrawn.The

2、 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 publication does not purport to include all the necessary provisions of a contrac

3、t. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 84724 0ICS 11.040.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the author

4、ity of the Standards Policy and Strategy Committee on 30 June 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 23317:2014 ISO 2014Implants for surgery In vitro evaluation for apatite-forming ability of implant materialsImplants chirurgicaux valuation in vitro de

5、la capacit de formation dapatite des matriaux dimplantsINTERNATIONAL STANDARDISO23317Third edition2014-06-15Reference numberISO 23317:2014(E)BS ISO 23317:2014ISO 23317:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part

6、of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body

7、 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 23317:2014ISO 23317:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Sc

8、ope . 12 Normative references 13 Terms and definitions . 14 Apparatus . 25 Test specimen 25.1 Specimen configuration and size 25.2 Specimen preparation 26 Simulated body fluid . 36.1 General . 36.2 Reagents for SBF 36.3 Preparation of SBF . 46.4 Confirmation of ion concentration of SBF . 66.5 Preser

9、vation of SBF . 67 Procedure. 68 Test report . 8Annex A (informative) Apparatus for preparing SBF 9Annex B (informative) Preparation of standard glasses for evaluating apatite-forming ability 10Bibliography .12BS ISO 23317:2014ISO 23317:2014(E)ForewordISO (the International Organization for Standard

10、ization) 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 to

11、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.The procedures used

12、to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of

13、the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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. Details of any patent rights identified d

14、uring the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the m

15、eaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 1

16、50, Implants for surgery, Subcommittee SC 1, Materials.This third edition cancels and replaces the second edition (ISO 23317:2012), which has been editorially revised.iv ISO 2014 All rights reservedBS ISO 23317:2014ISO 23317:2014(E)IntroductionIt has been revealed that materials of various kinds bon

17、d to living bone through a layer of apatite. It has been shown that this apatite layer can be reproduced on their surfaces 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 similar to the b

18、one mineral in its composition and structure.This evaluation of apatite-forming ability on implant material in SBF 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

19、 on its surface. The material then connects to the living tissue through this apatite layer without a distinct 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 similar to bone mineral in its composition

20、 and structure. As bioactivity increases, apatite forms on the material surface in a shorter time in proportion to this increase. The formation of apatite layers can be detected by thin film X-ray diffraction spectrometry and/or scanning electron microscopy.The apatite formed in the SBF is, however,

21、 similar to bone apatite in the following points. Ca-deficient type apatite. Lower Ca/P atomic ratio than stoichiometric apatite. Containing some impurities such as Mg2+, Na+, Cl-, HCO3-. Low crystallinity.NOTE 1 The material which forms apatite on its surface in vivo can bond to living bone, since

22、this apatite is biologically active. Their in vivo apatite deposition can be reproduced on their surfaces even in vitro in SBF. For example, in vivo calcification on surfaces of Bioglass1), CaO-SiO2glasses, Na2O-CaO-SiO2glasses, Cerabone2)A-W, Ceravital3)-type glass-ceramic, sintered hydroxyapatite

23、and alkali-heat-treated titanium metal, are correlated with 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-trica

24、lcium phosphate (Ca3(PO4)2) and calcium carbonate bond to 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-SiO2show a correlation between bone-forming ability of materials implanted into a bone

25、defect of a rabbit and apatite-forming ability on its surface in SBF.1) Trade names of products are an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product.2) Trade

26、names of products are an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product.3) Trade names of products are an example of a suitable product available commercially.

27、 This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product. ISO 2014 All rights reserved vBS ISO 23317:2014BS ISO 23317:2014Implants for surgery In vitro evaluation for apatite-forming ability of implant materials1 ScopeThis

28、 International Standard specifies a method for detecting apatite formed on a surface of a material in simulated body fluid (SBF). It is applicable to implant surfaces intended to come into direct bone contact.2 Normative referencesThe following documents, in whole or in part, are normatively referen

29、ced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3696:1987, Water for analytical laboratory use Specification and test met

30、hodsISO 14630, Non-active surgical implants General requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 14630 and the following apply.3.1apatitegroup of calcium-phosphates including bone mineral and the main inorganic constituent of bones and

31、teeth similar to hydroxyapatite, which has the composition Ca10(PO4)6(OH)2Note 1 to entry: Bone mineral also contains ions such as C032, F, Na+and Mg2+.3.2apatite-forming abilitycapability to develop apatite on the surface3.3bioactivityproperty that elicits a specific biological response at the inte

32、rface of the material, which results in the formation of a bond between tissue and material3.4induction periodtime to detect apatite formation on a surface of a specimen after soaking the specimen in simulated body fluid3.5simulated body fluidSBFinorganic solution having a similar composition to hum

33、an blood plasma without organic components3.6standard glass for evaluating apatite-forming abilityclass of standard glasses with certain chemical compositions as shown in Annex B showing given apatite-forming abilities in SBF and when implanted in an animal bodyINTERNATIONAL STANDARD ISO 23317:2014(

34、E) ISO 2014 All rights reserved 1BS ISO 23317:2014ISO 23317:2014(E)3.7thin film X-ray diffraction spectrometryTF-XRDmethod for detecting minerals in a thin layer at the surface of a material from a diffraction pattern obtained by X-ray with small glancing angle against the surface of the sample4 App

35、aratus4.1 Electric balance, capable of measuring a mass with an accuracy of 1 mg.4.2 Water bath equipped with magnetic stirrer, to maintain temperature of the solution within the range of (36,5 2) C and an accuracy of 0,2 C.4.3 pH meter, capable of measuring the pH of a solution with an accuracy of

36、0,01.4.4 Thermometer, capable of measuring the temperature of a solution with an accuracy of 0,1C.4.5 Thin film X-ray diffraction spectrometer (TF-XRD), capable of detecting apatite formed in a thin layer at the surface of a material.4.6 Scanning electron microscope (SEM), capable of observing apati

37、te grains and/or layers formed on a plain surface of a material with a magnification up to 10 000.5 Test specimen5.1 Specimen configuration and sizeThis International Standard allows specimens of any configuration and size derived from implant parts and devices to be used. However, a disc or rectang

38、ular plate specimen is highly recommended, because bioactivity of a material is evaluated by confirmation of apatite formed on the surface of the material using TF-XRD and/or SEM. Recommended specimen dimensions are shown in Figure 1.Dimensions in millimetresa) Disc specimen b) Rectangular specimenF

39、igure 1 Recommended specimen dimensions5.2 Specimen preparation5.2.1 GeneralThis International Standard allows several options for specimen preparation. The specimens should be machined, if necessary, to alter the configurations of original implants.2 ISO 2014 All rights reservedBS ISO 23317:2014ISO

40、 23317:2014(E)5.2.2 Basic machining procedureIn the case of a rectangular thin plate specimen as shown in Figure 1 b, the following procedure shall be used. Specimens shall be ground using a diamond wheel of grit size between 120 and 400. Conditions such as depth of cut per pass, wheel speed and oth

41、ers depend on the ground material. Water soluble materials, such as bioactive standard glasses, shall be machined under non-aqueous conditions.Where a customary machining procedure has been developed that is completely satisfactory for apatite-forming ability testing, this customary procedure can be

42、 used.6 Simulated body fluid6.1 GeneralSimulated body fluid (SBF) as defined in Table 1 shall be used.Table 1 Ion concentrations of SBF and human blood plasmaIonConcentration (103mol) inSBF (pH 7,40)Blood plasma (pH 7,2 to 7,4)Na+142,0 142,0K+5,0 5,0Mg2+1,5 1,5Ca2+2,5 2,5Cl147,8 103,0HCO34,2 27,0HPO

43、421,0 1,0SO420,5 0,5NOTE 1 For SBF as defined in Table 1, a correlation was observed between in vivo bone ingrowth and in vitro apatite-forming ability.NOTE 2 Other kinds of SBFs have been proposed in the literature, some of which have shown a correlation between in vivo bone ingrowth and in vitro a

44、patite-forming ability.6.2 Reagents for SBFFor the preparation of SBF only reagents of the following recognized analytical grade chemicals and only water in accordance with ISO 3696:1987, grade 2, shall be used.6.2.1 Sodium chloride (NaCl)6.2.2 Sodium hydrogen carbonate (NaHCO3)6.2.3 Potassium chlor

45、ide (KCl)6.2.4 Di-potassium hydrogen phosphate trihydrate (K2HPO4 3H2O)6.2.5 Magnesium chloride hexahydrate (MgCl2 6H2O)6.2.6 Hydrochloric acid solution, c(HCl) = 1 mol/l. ISO 2014 All rights reserved 3BS ISO 23317:2014ISO 23317:2014(E)6.2.7 Calcium chloride (CaCl2) or calcium chloride dihydrate (Ca

46、Cl2 2H2O)6.2.8 Sodium sulfate (Na2SO4)6.2.9 Tris-hydroxymethyl aminomethane (TRIS): (HOCH2)3CNH2)6.3 Preparation of SBF6.3.1 GeneralSince SBF is supersaturated with respect to apatite, an inappropriate preparation method can lead to the homogeneous precipitation of apatite in the solution.During its

47、 preparation the solution shall remain colourless, transparent and without deposit on the surface of the bottle. If any precipitation occurs, stop preparing SBF, abandon the solution and restart by washing the apparatus.In Table 2, the reagents for the preparation of 1 l of SBF are given in the requ

48、ired order of dissolution.Table 2 Ion concentrations of SBF and human blood plasmaOrder Reagent Amount aContainer Purity bFormula weight1 6.2.1 8,035 g weighing paper 99,5 % 58,443 02 6.2.2 0,355 g weighing paper 99,5 % 84,006 83 6.2.3 0,225 g weighing bottle 99,5 % 74,551 54 6.2.4 0,231 g weighing

49、bottle 99,0 % 228,222 05 6.2.5 0,311 g weighing bottle 98,0 % 203,303 46 6.2.6 39 mlgraduated cyl-inder 7 6.2.7 c0,292 g weighing bottle 95,0 % 110,984 88 6.2.8 0,072 g weighing bottle 99,0 % 142,042 89 6.2.9 6,118 g weighing paper 99,0 % 121,135 610 6.2.6 0 ml to 5 ml syringe dropper aThe amounts of the reagents are changed depending upon their purities.b The purity given in this table is a typical purity for reagent available in most countries.c If calcium chloride dihydrate (CaCl2) 2H2O is used, a