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
《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》由会员分享,可在线阅读,更多相关《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(2页珍藏版)》请在麦多课文档分享上搜索。
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
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