ASTM F1088-2004ae1 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

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1、Designation: F 1088 04ae1Standard Specification forBeta-Tricalcium Phosphate for Surgical Implantation1This standard is issued under the fixed designation F 1088; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last rev

2、ision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTESubsection 3.2 was editorially corrected in June 2006.1. Scope1.1 This specification covers chemical and crystallographicrequiremen

3、ts for biocompatible beta-tricalcium phosphate (b-TCP) for surgical implant applications. For a material to beidentified as medical grade beta-tricalcium phosphate, it mustconform to this specification (see Appendix X1).2. Referenced Documents2.1 ASTM Standards:2F 748 Practice for Selecting Generic

4、Biological Test Meth-ods for Materials and DevicesF 981 Practice for Assessment of Compatibility of Bioma-terials 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

5、.3 International Organization for Standardization 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.

6、 Chemical Requirements3.1 Elemental analysis 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 quantitativ

7、e X-ray diffraction analysis shall indicate 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:Eleme

8、ntOther Metalsppm, maxPb 30Hg 5As 3Cd 5Inductively 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

9、 tothe manufacturing techniques and raw materials.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 responsibili

10、ty ofSubcommittee F04.13 on Ceramic Materials.Current edition approved May 1, 2004. Published June 2004. Originallyapproved in 1987. Last previous edition approved in 2004 as F 1088 04.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceast

11、m.org. For 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 53203-3005.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.

12、,4th Floor, New York, NY 10036.5Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852.6Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements inNational Bureaus of Standards Geological Reference Materials SRM 278 Obsidianand SRM 688 Basalt by Inducti

13、vely Coupled PlasmaAtomic Emission Spectrom-etry,” Geostandards Newsletter, Vol 7, 1983, pp. 335-340.7International Centre for Diffraction Data, 12 Campus Blvd, Newtown Square,PA 19073-3273.8Forman, D. W. and Metsger, D. S., “The Determination of Phase Compositionof Calcium Phosphate Ceramics by X-R

14、ay Diffraction,” Transactions of the SeventhAnnual 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 Hydrxyapatite,” Bioceramics 16, Key Engineering Mate

15、ri-als, Vols 254-256, 2004, pp. 297-300.10Rietveld, 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 identical to that fortribasic calcium phosphate

16、 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 quality program, such asthe program defined in A

17、SQ 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 medical device applications. The chemical,cryst

18、allographic, 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 environments.X1.2 It is recognized that a separate

19、 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. BIOCOMPATIBILITYX2.1 This specification is needed to e

20、nsure 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 Practices F 981 andF 748 or equivalent. The chemical

21、, 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 specific application. Thebiological test appropriate

22、for the specific site, such as recom-mended in Practice F 748 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 patent rights asserted in connection with any

23、 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 revision at any time by the responsible technical

24、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 comments will receive careful consideration at

25、 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 copyrighted by ASTM International, 100 Barr Harbor D

26、rive, 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).F 1088 04ae12