GOST R ISO 13175-3-2015 Implants for surgery Calcium phosphates Part 3 Hydroxyapatite and beta-tricalcium phosphate bone substitutes《外科植入物 磷酸钙 第3部分 羟磷灰石和β-磷酸三钙骨替代品》.pdf

1、 13175-32015 3 - ISO 13175-3:2012Implants for surgery Calcium phosphates Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes(IDT) 1 - ( ) - , 42 422 3 - 20 2015 . 148-4 13175-3:2012 . . 3. - (ISO 13175-3:2012 Implants for surgery Calcium phosphates Part 3:Hydroxyapatite and beta-tr

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4、1603011 -, c98- /c98- . , , , - .2 . - . , . 2591-1:1988 . 1. - (ISO 2591-1:1988, Testsieving art 1: ethods using test sieves of woven wire cloth and perforated metal plate) 10993-1:2009 . 1. (ISO 10993-1:2009, Biological evaluation of medical devices Part 1:Evaluation and testing within a risk mana

5、gement process) 13320:2009 . (ISO 13320:2009,Particle size analysis Laser diffraction methods) 13383-1:2012 ( , - ). . 1. (ISO 13383-1:2012, Fine ceramics (advanced ceramics, advanced technicalceramics) Microstructural characterization Part 1: Determination of grain size and size distribution) 13779

6、-3:2008 . . 3. (ISO 13779-3:2008, Implants forsurgery Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity) 15901-1:2005 - . 1. (ISO 15901-1:2005, Pore size distribution and porosity of solid materials by mercury porosimetry and gasadsorption Part 1: Mercur

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8、6 : ,10.3.1.7 : ,10.3.1.8 : .3.1.9 TTCP: -,ICDDPDF25-1137ICDDPDF70-1379. Ca4(PO4)2O.3.1.10 : ,- , ( ), . .3.1.11 CaO: , -ICDDPDF4-0777ICDDPDF82-1690.3.1.12 c98- (dc98TCP): c98-,3,073.3.1.13 (dHA): ,3,153.3.2 dr ;dth ;m;V.4 4.1 c98-1.1),.2 13175-32015 1 , / 3 5 5 30 50 - - - (ICP/AES), - - (ICP/MS),

9、- (AAS), , 13779-3. - . 1 . - , , : , , , , , , , . . 1000 / , , . - 10993-1.- , , - 10993-1.4.2 4.2.1 - (XRD) 13779-3.4.2.2 95 % . CaO 1 % . (1)MFHA=100%MFc98TCPMFc97TCP MFTTCP MFCaO, (1) MFHA HA;MFc98 TCP c98-TCP;MFc97TCP c97-TCP;MFTTCP TTCP;MFCaO CaO. , .4.2.3 c98- - c1775 % () . 60%HA40%TCP,(65%HA35%TCP)(55%HA45%TCP). : - c97- (c97-TCP), .4.2.4 c98- c98- 95 % .3 13175-32015 c98- (2)MFc98TCP=100%MFHA. (2) HA , . : c97 - (c97-TCP), . - (FTIR) - 13779-3.4.3 ( ) . :- ;-