ASTM F1088-2004a(2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation《外科植入物用β- 磷酸三钙的标准规范》.pdf

1、Designation: F1088 04a (Reapproved 2010)Standard Specification forBeta-Tricalcium Phosphate for Surgical Implantation1This standard is issued under the fixed designation F1088; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the ye

2、ar of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 Thisastm specification covers chemical and crystallo-graphic requirements for biocompatible beta-tricalcium phos

3、-phate (b-TCP) for surgical implant applications. For a materialto be identified as medical grade beta-tricalcium phosphate, itmust conform to this specification (see Appendix X1).2. Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Meth-ods for Materials an

4、d DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 American Society for Quality (ASQ) Document:C1 Specification of General Requirements for a QualityProgram32.3 International Organization for Standard

5、ization Docu-ment:ISO 10993 Biological Evaluation of Medical Devices42.4 United States Pharmacopeia (USP) Documents:5Identification Tests for Calcium and Phosphate Lead Mercury Arsenic Heavy Metals Method 12.5 Other Reference:U.S. Geological Survey Method63. Chemical Requirements3.1 Elemental analys

6、is for calcium and phosphorus will beconsistent with the expected stoichiometry of beta-tricalciumphosphate (Ca3(PO4)2. The calcium and phosphorus contentshall be determined using a suitable method such as USP(see 2.4) or X-ray fluorescence.3.2 A quantitative X-ray diffraction analysis shall indicat

7、e aminimum beta-tricalcium phosphate content of 95 % as deter-mined using Powder Diffraction File #5508987and a methodequivalent to Forman8or Rietveld.9,103.3 For beta-tricalcium phosphate, the concentration oftrace elements shall be limited as follows:ElementOther Metalsppm, maxPb 30Hg 5As 3Cd 5Ind

8、uctively coupled plasma/mass spectroscopy (ICP/MS),atomic absorption spectroscopy (AAS), or the methods listedin 2.4 and 2.5 shall be used.3.3.1 The analysis of other trace elements may be required,based on the conditions, apparatus, or environments specific tothe manufacturing techniques and raw ma

9、terials.3.4 The maximum allowable limit of all heavy metalsdetermined as lead will be 50 ppm as described in 2.4 or1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materi

10、als.Current edition approved Sept. 1, 2010. Published November 2010. Originallyapproved in 1987. Last previous edition approved in 2004 as F1088 04a1. DOI:10.1520/F1088-04AR10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. Fo

11、r Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.4Available from American National Standards Institute (ANSI), 25 W. 43r

12、d St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.6Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements inNational Bureaus of Standards Geological Reference Materi

13、als SRM 278 Obsidianand SRM 688 Basalt by Inductively Coupled PlasmaAtomic Emission Spectrom-etry,” Geostandards Newsletter, Vol 7, 1983, pp. 335340.7International Centre for Diffraction Data, 12 Campus Blvd, Newtown Square,PA 19073-3273.8Forman, D. W. and Metsger, D. S., “The Determination of Phase

14、 Compositionof Calcium Phosphate Ceramics by X-Ray Diffraction,” Transactions of theSeventh Annual Meeting of the American Society for Bone and Mineral Research,Kelseyville, CA, 1985 p. 391.9Jackson, L. E., Barralet, J. E., and Wright,A. J., “RietveldAnalysis in SinteringStudies of Ca-Deficient Hydr

15、xyapatite,” Bioceramics 16, Key Engineering Mate-rials, Vols 254-256, 2004 , pp. 297300.10Rietveld, H. M., Acta Crystallogr., Vol 22, 1967, p. 151.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.equivalent. Sample preparation will be

16、 identical to that fortribasic calcium phosphate as specified in the National Formu-latory (see 2.4).3.5 It is recommended that all metals or oxides present inconcentrations equal or greater than 0.1 % be noted in materialdescriptions.4. Quality Program Requirements4.1 The producer shall maintain a

17、quality program, such asthe program defined in ASQ C1.5. Keywords5.1 advanced ceramics; b-TCP; beta-tricalcium phosphate;calcium phosphate material; ceramic; surgical implantAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification is needed to ensure a high qualitymaterial for use in

18、 medical device applications. The chemical,crystallographic, and phase requirements serve as criteria for ahigh-purity, consistent product that can be implanted in thebody. These requirements provide specifications for biocom-patible grades of beta-tricalcium phosphate for use in thephysiological en

19、vironments.X1.2 It is recognized that a separate performance standardmay be necessary for each end-use product. For this reason,physical and mechanical properties were not specified. Asource of general test methods for ceramics may be found inVol 15.02 of the Annual Book of ASTM Standards.X2. BIOCOM

20、PATIBILITYX2.1 This specification is needed to ensure a high qualitymaterial for use in biological applications. beta-tricalciumphosphate has been demonstrated to exhibit a well character-ized biological response equivalent or better than that exhibitedby reference materials cited and tested in Prac

21、tices F981 andF748 or equivalent. The chemical, crystallographic, and phaserequirements contained in this specification serve as criteria fora high purity, consistent product that can be implanted in thebody. The suitability of the material from a human implantperspective is dependent on the specifi

22、c application. Thebiological test appropriate for the specific site, such as recom-mended in Practice F748 or ISO 10993 should be used as aguideline. Further testing of specific properties may be re-quired for specific applications.ASTM International takes no position respecting the validity of any

23、patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revis

24、ion at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your c

25、omments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrig

26、hted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F1088 04a (2010)2