KS P ISO 23317-2009 Implants for surgery－In vitro evaluation for apatite-forming ability of implant materials《外科植入物 植入材料磷灰石形成能力的体外评估》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 23317 (apatite) KS P ISO 23317:2009 2009 12 29 http:/www.kats.go.krKS P ISO 23317:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： (ISO/TC 150) ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 23317:2009 i i

2、i 1 1 2 1 3 .1 4 2 5 2 5.1 .2 5.2 .3 6 3 6.1 .3 6.2 SBF 3 6.3 SBF pH .4 6.4 SBF 4 6.5 SBF 6 6.6 SBF 7 7 7 8 .8 A( ) SBF .9 B( ) .10 12 KS P ISO 23317:2009 ii 2007 1 ISO 23317, Implants for surgery In vitro evaluation for apatite-forming ability of implant materials . . . , , . , , . KS P ISO 23317:2

3、009 (apatite) Implants for surgery In vitro evaluation for apatite-forming ability of implant materials 1 (SBF) . 2 . . ( ) . KS M ISO 3696, KS P ISO 14630, 3 KS P ISO 14630 . 3.1 (apatite) (bone mineral) Ca10(PO4)6(OH)2 CO23, F, Na+ Mg2+ . 3.2 3.3 (bioactivity) 3.4 KS P ISO 23317:2009 2 3.5 SBF 3.6

4、 SBF 3.7 X- TF-XRD X- 4 4.1 , 1 mg 4.2 , 36.0 40.0 4.3 pH , 0.01 pH 4.4 X- , 4.5 , 10 000 / 5 5.1 . TF-XRD / SEM . 1 . KS P ISO 23317:2009 3 : mm a) b) 1 5.2 5.2.1 . . 5.2.2 1 b) , . 120 400 , (depth of cut per pass), . . , . 6 6.1 1 (SBF) . 1 1 SBF . 2 SBF . 6.2 SBF . SBF KS M ISO 3696, 2KS P ISO 2

5、3317:2009 4 . a) (NaCl) b) (NaHCO3) c) (KCl) d) (K2HPO4 3H2O) e) (MgCl2 6H2O) f) (CaCl2) g) (Na2SO4) h) - (TRIS) : (HOCH2)3CNH2 i) , c(HCl) 1 mol/L j) pH , (pH 4, pH 7 pH 9) 6.3 SBF pH SBF pH 1 . 1 SBF (10-3mol) SBF(pH 7.40) (pH 7.2 7.4) Na+142.0 142.0 K+5.0 5.0 Mg2+1.5 1.5 Ca2+2.5 2.5 Cl147.8 103.0

6、 HCO34.2 27.0 HPO241.0 1.0 SO240.5 0.5 6.4 SBF 6.4.1 SBF . . , SBF . 2 SBF 1 L . KS P ISO 23317:2009 5 2 SBF 1 L , , , g u 1 NaCl 8.035 99.5 % 58.443 0 2 NaHCO30.355 99.5 % 84.006 8 3 KCl 0.225 99.5 % 74.551 5 4 K2HPO4 3H2O 0.231 99.0 % 228.222 0 5 MgCl2 6H2O 0.311 98.0 % 203.303 4 6 c(HCl) 1 mol/L

7、39 7 CaCl20.292 95.0 % 110.984 8 8 Na2SO40.072 99.0 % 142.042 8 9 TRIS 118 99.0 % 121.135 6 10 c(HCl) 1 mol/L 0 5 6.4.2 1 1 L 700 mL . (4.2) . (36.51.5) . A SBF . 6.4.3 2 2 (36.51.5) . a) . . b) ( ) . c) CaCl2 . CaCl2 . d) 1M-HCI 1M-HCI . e) KCl, K2HPO4 3H2O, MgCl2 6H2O, CaCl2, Na2SO4 . 6.4.4 3 pH (

8、4.3) . TRIS pH 2.01.0 . 6.4.5 4 (36.51.5) . 900 mL , 0.9 L . 6.4.6 5 35 38 : (36.50.5) pH TRIS . TRIS pH . KS P ISO 23317:2009 6 TRIS . pH TRIS . . (36.50.5) , pH 7.30.05 TRIS (36.50.5) . (36.50.5) TRIS pH 7.45 . pH (36.51.5) pH 0.05 . (36.50.5) 7.45 pH . 6.4.7 6 (36.50.5) . pH 7.450.01 TRIS . pH 7.

9、420.01 pH 7.40 . pH 7.420.01 pH 7.45 TRIS . TRIS , 1M-HCl TRIS . pH 7.42 7.45 , TRIS . TRIS (36.50.2) . (36.50.2) , pH 7.420.01 pH , / 0.1 /min 36.5 7.40 . 6.4.8 7 pH . 6.4.9 8 pH 1 L . . . 6.4.10 9 ( ). . 6.4.11 10 20 . 6.4.12 11 20 . 6.5 SBF SBF 1 . SBF SBF SBF . SBF . KS P ISO 23317:2009 7 B.1 .

10、A, B C SBF 12 , 24 120 TF-XRD . 6.6 SBF SBF (5 10) . SBF 30 . 7 7.1 0.1 mm , 2 mm2 . a) b) 2 SBF ( ) 7.2 SBF . s Sa /10 , s： SBF (mm3) Sa： (mm2) , SBF s . 7.3 SBF . SBF 36.5 , 2 SBF . SBF . , SBF . 2 a) 2 b) SBF . 2 b) , . 7.4 36.5 4 SBF SBF . 4 . . SBF KS P ISO 23317:2009 8 . 4 . 7.5 X- (TF-XRD) /

11、(4.5) . CuK( 0.154 05 nm) (glancing angle) 1 2/min 2 (), 3 50 TF-XRD . (SEM) . SEM ( 10 000) ( 1 000) . TF-XRD . SEM . SEM TF-XRD . , SEM . 8 . a) , b) c) d) ( ) e) SBF f) SBF ( ) g) (TF-XRD / SEM) h) TF-XRD / SEM i) ( ) j) k) l) ( , KS P ISO 23317) KS P ISO 23317:2009 9 A ( ) SBF 1 2 3 4 5 A.1 SBF

12、KS P ISO 23317:2009 10 B ( ) B.1 . SiO2, Na2CO3 CaCO3 . B.1 . B.2 . . Na2CO3, CaCO3 SiO2 1 000 10 , 600 2 , 550 1 . 30 . ( A, B C ) 1 400 1.5 2 mm . 2 mm . 500 . , No. 400 . 1 2 . 3 4 . 5 B.1 Na2O-CaO-SiO2 KS P ISO 23317:2009 11 B.1 Na2O-CaO-SiO2 % Na2O CaO SiO2 A 25 25 50 B 22.5 22.5 55 C 20 20 60

13、B.2 % Na2CO3CaCO3SiO2 A 32.54 30.73 36.74 B 30.08 28.41 41.51 C 27.49 25.96 46.56 KS P ISO 23317:2009 12 KS P ISO 23317:2009 13 (apatite) 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 23317:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryIn vitro evaluation for apatite-forming abilityof implant materials ICS 11.040.40