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
2、icalcium phosphate bone substitutes). - , 5 1.02012 ( 8). ( 1 ) , . () . , (www.gost.ru) , 2015 , - - II 13175-320151 .12 13 , .23.1 23.2 .24 .24.1 24.2 .34.3 .44.4 44.5 pH54.6 54.7 8 () .1011III 13175-32015 ( ) ( ISO). - . , , . , , , - . - () . , /, 2. . - , , - . 75 % - . , - . - . 13175-3 / 150,
3、 , SC 1, . 13175 . :- 3. - . c98- . , - , - . , , c98- -, , (. 6 7). c98- (. 8)., , : c98- /c98- . /c98- : c98- , (. 911). , (. 1216). , - , -. : , (. 14). , . , , . .IV 13175-32015 3 - Implants for surgery. Calcium phosphates. Part 3. Hydroxyapatite and beta-tricalcium phosphate bone substitutes 20
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
7、y porosimetry) 80000-1:2009 . 1. (ISO 80000-1:2009, Quantitiesand units Part 1: General)1 13175-32015 3 , 3.1 :3.1.1 c97- (c97-TCP): -,ICDDPDF1)09-0348. Ca3(PO4)2.3.1.2 c98- (c98-TCP): -,ICDDPDF09-0169. Ca3(PO4)2.3.1.3 : ,-,.3.1.4 (HA): , -ICDDPDF09-0432ICDDPDF72-1243. Ca10(PO4)6(OH)2.3.1.5 : ,.3.1.
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 ( ) . :- ;-
