ISO 13779-1-2008 Implants for surgery - Hydroxyapatite - Part 1 Ceramic hydroxyapatite《外科植入物 羟基磷灰石 第1部分 陶瓷羟基磷灰石》.pdf

1、 Reference numberISO 13779-1:2008(E)ISO 2008INTERNATIONAL STANDARD ISO13779-1Second edition2008-10-01Implants for surgery Hydroxyapatite Part 1: Ceramic hydroxyapatite Implants chirurgicaux Hydroxyapatite Partie 1: Cramique base dhydroxyapatite ISO 13779-1:2008(E) PDF disclaimer This PDF file may co

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6、f 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 2008 All rights reservedISO 13779-1:2008(E) ISO 2008 All rights reserved iiiForeword ISO (the International Org

7、anization 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 committee has been establi

8、shed 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 electrotechnical standardizatio

9、n. 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 International Standards adopted by the technical committees are circulated to the member bodies for voting.

10、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 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such pat

11、ent rights. ISO 13779-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. This second edition cancels and replaces the first edition (ISO 13779-1:2000), which has been technically revised. ISO 13779 consists of the following parts, under the general

12、title Implants for surgery Hydroxyapatite: Part 1: Ceramic hydroxyapatite Part 2: Coatings of hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity Part 4: Determination of coating adhesion strength ISO 13779-1:2008(E) iv ISO 2008 All rights reservedIntroduc

13、tion No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in ISO 13779 has shown that an acceptable level of biological response can be expected, if the mater

14、ial is used in appropriate applications. The biological response to hydroxyapatite ceramic has been demonstrated by a history of clinical use and by laboratory studies. See Bibliography. INTERNATIONAL STANDARD ISO 13779-1:2008(E) ISO 2008 All rights reserved 1Implants for surgery Hydroxyapatite Part

15、 1: Ceramic hydroxyapatite 1 Scope This part of ISO 13779 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants. This part of ISO 13779 applies to hydroxyapatite blocks. It does not apply to hydroxyapatite coatings, hydroxyapatite powder or nanoparticle-type and cal

16、cium phosphate ceramics which are not mainly composed of crystalline hydroxyapatite. This part of ISO 13779 does not apply to nanoparticle-type materials. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the

17、edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances ISO 13779-3, Implants for surgery Hydroxyapatite

18、 Part 3: Chemical analysis and characterization of crystallinity and phase purity 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 ceramic hydroxyapatite hydroxyapatite that has been sintered into a coherent crystalline mass and which contains

19、 more than 50 % mass fraction of crystalline hydroxyapatite 3.2 hydroxyapatite chemical compound with a crystallographic structure characterized by the powder diffraction file PDF 9-432 of the International Committee for Diffraction Data ICDD, USA NOTE The chemical formula is Ca5(OH)(PO4)3. ISO 1377

20、9-1:2008(E) 2 ISO 2008 All rights reserved3.3 sintering process for production of ceramics in which the application of heat causes a significant reduction of particle surface area and bulk volume to achieve densification and consequent increase in mechanical properties 4 Requirements 4.1 Chemical an

21、alysis The content of calcium and phosphorus of the hydroxyapatite ceramic shall be determined in accordance with ISO 13779-3. The calcium to phosphorus ratio, Ca:P, shall have a value of 1,65 u Ca:P u 1,82 for the atomic ratio. This shall be determined as specified in ISO 13779-3. 4.2 Trace element

22、s The limits of specific trace elements for ceramic hydroxyapatite are given in Table 1. The maximum allowable limit for metals having adverse biological reactions shall be 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

23、other chemical impurities shall be in accordance with ISO 10993-17. Table 1 Limits of specific trace elements Trace element Maximum limit mg/kg Arsenic 3 Cadmium 5 Mercury 5 Lead 30 4.3 Crystalline phase compositions Allowed % mass fraction of crystalline phases: hydroxyapatite shall be 50 % mass fr

24、action or greater; -tricalcium phosphate (-TCP), -tricalcium phosphate (-TCP), tetracalcium phosphate (TTCP) and calcium oxide (CaO) shall each be equal to or less than 5 % mass fraction. 4.4 Crystallinity value The hydroxyapatite phase (50 % mass fraction or higher) shall have a crystallinity value

25、 not less than 95 % of the 100 % crystalline hydroxyapatite standard value as determined by ISO 13779-3. 4.5 Mechanical properties Compression strength The compression strength shall be determined by applying an axial load to a cylindrical test specimen of height h, and diameter d, with a ratio of d

26、imensions h:d between 1,5 and 2,0. The compression strength shall be calculated by determining the mean value of the load force recorded at the first significant deviation from linearity in the load-deflection diagram. NOTE If the implant is designed for load bearing applications, the manufacturer s

27、hould demonstrate that the mechanical strength of the implants is adapted to local stresses. ISO 13779-1:2008(E) ISO 2008 All rights reserved 3Bibliography 1 ISO 5961:1994, Water quality Determination of cadmium by atomic absorption spectrometry 2 ISO 8288:1986, Water quality Determination of cobalt

28、, nickel, copper, zinc, cadmium and lead Flame atomic absorption spectrometric methods 3 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, -tri-calciumorthophosphate, -tri-calciumorthophosphate, tetra-calciumphosphate, calciu

29、m oxide, monetite, brushite, aragonite, calcite 4 ASTM F 1185-03, Standard Specification for Composition of Hydroxylapatite for Surgical Implants 5 NF S 94-065, Materials for surgical implants Determination of arsenic, mercury, cadmium and lead on coatings based on phosphate of calcium 6 NF S 94-066

30、, Materials for surgical implants Quantitative determination of the Ca/P ratio of calcium phosphate 7 NF S 94-067, Materials for surgical implants Qualitative and quantitative determination of the foreign phases present in calcium phosphate based powders, deposits and ceramics 8 NF S 94-068, Materia

31、ls for surgical implants Determination of the crystallinity and apparent size of the apatite crystallites of hydroxyapatite based powders, deposits and ceramics 9 Hideki Aoki, Medical Applications of Hydroxyapatite, Ishiyaku EuroAmerica, Tokyo, 1994 10 DENISSEN, H., Dental Root Implants of Apatite C

32、eramics, Doctoral Thesis, Vrije Universiteit Amsterdam, 1979 11 QUINN, J.H. and KENT, J.N., Alveolar Ridge Maintenance with Solid Non-porous Hydroxyaptite Root Implants, Oral Surg., 58, pp. 511-516, 1984 12 DE GROOT, K., Bioceramics of Calcium Phosphate, CRC Press, Boca Raton, USA, 1983 13 OONISHI,

33、H. et al., Clinical Significance of Chemical Bonds between Bioactive Ceramics and Bone in Orthopaedic Surgery, Bioceramics 2, edited by G. Heimke, Deutsche Keramische Gesellschaft 14 LEGEROS, R.Z. and LEGEROS, J.P., Dense Hydroxyapaptite in Larry Hench & June Wilson (Eds), An Introduction to Bioceramics, World Scientific, pp. 199-221, 1993 ISO 13779-1:2008(E) ICS 11.040.40 Price based on 3 pages ISO 2008 All rights reserved