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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 13779-2:2000 ICS 1
2、1.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Implants for surgery Hydroxyapatite Part 2: Coatings of hydroxyapatite Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepare
3、d under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 November 2000 BSI 11-2000 ISBN 0 580 36465 8 BS ISO 13779-2:2000 Amendments issued since publication Amd. No.DateComments National foreword T
4、his British Standard reproduces verbatim ISO 13779-2:2000 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/18, Surgical implant materials, which has the responsibility to: aid enquirers to understand the text; present to t
5、he responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtain
6、ed on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facilit
7、y of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligatio
8、ns. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to iv, pages 1 to 4, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun shef
9、fieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 13779-2:2000(E) INTERNATIONAL STANDARD ISO 13779-2 First edition 2000-08-01 Implants for surgery Hydroxyapatite Part 2: Coatings of hydroxyapatite Implants chirurgicaux Hydroxyapatite Partie 2: Revtement
10、s base dhydroxyapatite Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-2:2000(E) ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-2:2000(E) iii Foreword ISO (th
11、e 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 technical committees. Each member body interested in a subject for which a technical committ
12、ee 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 with the International Electrotechnical Commission (IEC) on all matters of electrotechn
13、ical standardization. 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
14、 by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 13779 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 13779-2 wa
15、s prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. ISO 13779 consists of the following parts, under the general title Implants for surgery Hydroxyapatite: ?Part 1: Ceramic hydroxyapatite ?Part 2: Coatings of hydroxyapatite ?Part 3: Chemical analysis and
16、 characterization of crystallinity and phase purity ?Part 4: Determination of coating adhesion strength Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-2:2000(E) iv Introduction No known surgical implant material has ever been show
17、n to cause absolutely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 13779 has shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications. The bi
18、ological response to coatings of hydroxyapatite ceramic has been demonstrated by a history of clinical use and by laboratory studies. See Bibliography. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 13779-2:2000(E
19、) 1 Implants for surgery Hydroxyapatite Part 2: Coatings of hydroxyapatite 1 Scope This part of ISO 13779 specifies requirements for ceramic hydroxyapatite coatings applied to metallic or non- metallic surgical implants. This part of ISO 13779 does not apply to coatings made from glasses, glass cera
20、mics,?- and?-calcium orthophosphate or other forms of calcium phosphate, nor does it apply to coatings in which the hydroxyapatite is present in a powder form. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of
21、this part of ISO 13779. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 13779 are encouraged to investigate the possibility of applying the most recent editions of the normative document
22、s indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 10993-17:1?Biological evaluation of medical devices Part 17: Establishment of permissible limits and
23、process residues using health-based risk assessment. ISO 13779-3:1?Implants for surgery Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity. ISO 13779-4: 1?Implants for surgery Hydroxyapatite Part 4: Determination of coating adhesion strength. 3 Terms and
24、definitions For the purposes of this part of ISO 13779, the following terms and definitions apply. 3.1 ceramic hydroxyapatite hydroxyapatite which has been formed into a coherent crystalline mass by subjecting it to conditions at which the crystals in the powder fuse together 1? To be published. Lic
25、ensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-2:2000(E) 2 3.2 hydroxyapatite chemical compound with a crystallographic structure characterized by the powder diffraction file PDF 9-432 of the International Committee for Diffraction D
26、ata ICDD, USA NOTE The chemical formula is Ca5(OH)(PO4)3. 3.3 coating hydroxyapatite which has been deposited onto the surface of a metallic or non-metallic substrate, either by means of a thermal spray process which produces a ceramic-type coating, or by means of a solution based technique which ma
27、y deposit hydroxyapatite directly or may require thermal or other treatment to convert it into a crystalline form 4 Requirements 4.1 Chemical analysis The content of calcium and phosphorus of the hydroxyapatite ceramic coating shall be determined in accordance with ISO 13779-3. The calcium to phosph
28、orus ratio, Ca/P, shall have a value in the range of 1,67 to 1,76 for the atomic ratio. This shall be determined as specified in ISO 13779-3. 4.2 Trace elements The limits of specific trace elements for ceramic hydroxyapatite are given in Table 1. The maximum allowable limit for metals having advers
29、e biological reactions is a total of 50 mg/kg. The trace element levels shall be determined as specified in ISO 13779-3. Assessment of the risk posed by other chemical impurities shall be carried out in accordance with ISO 10993-17. Table 1 Limits of specific trace elements Trace element Maximum lim
30、it mg/kg Arsenic 3 Cadmium 5 Mercury 5 Lead 30 4.3 Crystalline content The content of crystalline hydroxyapatite shall be not less than 45 %. The maximum allowable level of other crystalline phases shall be 5 %, with the balance being amorphous. The quantitative determination of the content of the h
31、ydroxyapatite crystalline phase and of other crystalline phases shall be carried out in accordance with ISO 13779-3. 4.4 Adhesion to substrate The adhesion to the substrate material shall be determined in accordance with the method described in ISO 13779-4 and shall have a value for adhesion strengt
32、h of not less than 15 MPa. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-2:2000(E) 3 Bibliography 1 ISO 5961:1985, Water quality Determination of cadmium Flame atomic absorption spectrometric methods. 2 ISO 8288:1986, Water quali
33、ty Determination of cobalt, nickel, copper, zinc, cadmium and lead Flame atomic absorption spectrometric method. 3 ASTM C 633-79:1985, Standard test method for adhesion or cohesion strength of flame sprayed coatings. 4 ASTM F 1609:1995, Standard specification for calcium phosphate coatings for impla
34、ntable materials. 5 ASTM F 1185:1988, Standard specification for composition of ceramic hydroxyapatite for surgical implants. 6 ASTM F 1501:1995, Standard test method for tension testing of calcium phosphate coatings. 7 BS 5350 Part C15:1982, Standard test method for adhesion of coatings using a com
35、pressive method. 8 NF S 94-065, Materials for surgical implants Determination of arsenic, mercury, cadmium and lead on coating based on phosphate of calcium. 9 NF S 94-066, Materials for surgical implants Quantitative determination of the Ca/P ratio of calcium phosphate. 10 NF S 94-067, Materials fo
36、r surgical implants Qualitative and quantitative determination of the foreign phases present in calcium phosphate based powders, deposits and ceramics. 11 NF S 94-068, Materials for surgical implants Determination of the crystallinity and apparent size of the apatite crystallites of hydroxyapatite b
37、ased powders, deposits and ceramics. 12 NF S 94-071, Materials for surgical implants Determination of the surface finish of coatings used for biomedical applications. 13 NF S 94-072, Materials for surgical implants Determination of tensile adherence of phosphocalcic materials for biomedical applicat
38、ions. 14 JIS H 8666, Thermal sprayed ceramic coatings. 15 ICDD cards 9-432, 9-348, 9-169, 25-1137, 37-1497, 9-80, 9-77, 14-1475, 5-586 X-ray diffraction standards for hydroxyapatite,?-tricalcium orthophosphate,?-tricalcium orthophosphate, tetracalcium phosphate, calcium oxide, monetite, brushite, ar
39、agonite, calcite. 16 Hydroxyapatite Ceramic A Decade of Experience in Hip Arthroplasty, Symposium at Royal College of Surgeons of England, London, November 1995. 17 K. de GROOTet al., J. Biomed. Mater. Res., 21, pp. 1375ff, 1987. 18 A. MORONIet al., Bone Ingrowth Analysis and Interface Evaluation of
40、 Hydroxyapatite Coated Versus Uncoated Titanium Porous Bone Implants, in Bioceramics, T Yamamuro, T Kokubo, T Nakamura (eds.).,Vol. 5, Kobunshi Kankokai, Kyoto, 1992 pp. 299-305. 19 CPAT KLEINet al., Stability of calcium phosphate ceramics and plasma-sprayed coating, in An Introduction to Bioceramic
41、s, L. Hench and J. Wilson (eds.), World Scientific, 1993 pages 199-221. 20 S.D. COOKet al., Hydroxylapatite Coated Titanium for Orthopaedic Implant Applications,. Clin. Orthop. Rel. Res., 232, pp. 225-243, 1988. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontro
42、lled Copy, (c) BSI ISO 13779-2:2000(E) 4 21 G.W. HASTINGSet al., Hydroxyapatite coatings for biomaterials A report of a multi-centre investigation, in Bioceramics 7, .H. Andersson, R.P. Happonen, A. Yli-Urpo (eds.), Butterworth-Heinemann, Oxford, 1994, pp. 207-213. 22 A.M. TUDORet al., The analysis
43、of biomedical hydroxyapatite powders and hydroxyapatite coatings on metallic implants by near-IR Fourier Transform raman spectroscopy. Spectrochim, Acta, 49A, 4/6, pp. 675- 680, 1993. 23 A. MEROLLI, P. TRANQUILLI, LEALI. Crystallinity of the coating directs the in vivo response to hydroxyapatite in
44、the rabbit, in Bioceramics 7, .H. Andersson, R.P. Happonen, A. Yli-Urpo (eds.) Butterworth-Heinemann, Oxford, 1994, pp, 223-228. 24 R.G.T. GEESINKand M.T. MANLEY(eds.). Hydroxyapatite coatings in orthopaedic surgery, Raven Press, New York 1993. 25 Hideki AOKI, Medical Applications of Hydroxyapatite.
45、 Ishiyaku Euro America, Tokyo, 1994. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 13779-2:2000 BSI 389 Chiswick High Road Lo
46、ndon W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI British Standards Institution
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