1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 137793 3： KS P ISO 13779 3:2009 2009 12 29 http:/www.kats.go.krKS P ISO 137793 :2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： (ISO/TC 194) ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 137793 :2009 . i
2、ii 1 1 2 1 3 , .1 3.1 1 3.2 .2 4 2 5 , 3 5.1 3 5.2 3 5.3 X- 3 5.4 4 6 X- .4 6.1 .4 6.2 5 7 .5 7.1 .5 7.2 5 7.3 X- 6 8 6 8.1 .6 8.2 6 8.3 ： (Ca：P) .7 9 .8 9.1 .8 9.2 .8 10 Ca : P 8 10.1 8 10.2 .9 10.3 9 10.4 .9 10.5 10 i KS P ISO 137793 :2009 11 / .10 11.1 .10 11.2 10 12 10 12.1 10 12.2 10 12.3 .10 1
3、2.4 11 13 .11 14 .11 A () .12 B () .13 B.1 13 B.2 13 B.3 .13 C ( ) X- .14 D ( ) .16 E () .17 E.1 TCP .17 E.2 (TTCP) .17 E.3 ( TCP) .18 E.4 18 19 ii KS P ISO 137793 :2009 2008 1 ISO 13779 3, Implants for surgery HydroxyapatitePart 3 ：Chemical analysis and characterization of crystallinity and phase p
4、urity . . . , , . , , . iii KS P ISO 13779 3:2009 3： Implants for surgery Hydroxyapatite Part 3：Chemical analysis and characterization of crystallinity and phase purity 1 , . 2 . . ( ) . KS M ISO 3696, KS P ISO 10993 14, 14 ： KS P ISO 13779 2, 2： KS Q ISO/IEC 17025, ISO 565, Test sievesMetal wire cl
5、oth, perforated metal plate and electroformed sheet Nominal sizes of openings Sheets JCPDS 090169; JCPDS 9-348; JCPDS 9-432; JCPD S 72-1243; JCPDS 25-1137; JCPDS 70-1379; JCPDS 4-0777; JCPDS 82-1690 Elements of X-ray Diffraction, B. D. CULLINITY, 2nd ed., Addison-Wesley, Reading, MA, 1978(JCPDS Join
6、t Committee on Powder Diffraction Standards) 3 , 3.1 . 3.1.1 X- : (Ca : P) KS P ISO 137793 :2009 3.1.2 10 3.1.3 X- 3.1.4 X- 3.1.5 3.1.6 X- 3.2 p d 4 , . a) , “ ” b) - c) (flame atomic absorption spectroscopy after complexion and extraction) d) (ICP) e) (ICP-MS) . f) (AAS) g) (ICP-MS) 2 KS P ISO 1377
7、93 :2009 5 , 5.1 . a) KS M ISO 3696 2 A b) PTFE ( ) KS P ISO 13779 2 5.2 . 5.2.1 2 , KS M ISO 3696 5.2.2 52.5 % ( p1.33) 5.2.3 30 % ( )( p1.11) 5.2.4 , 5.3 X- 5.3.1 X- 2 0.02 . . X- 1/2 . . 5.3.2 . 5.3.2.1 , , 5.3.2.2 , ISO 565 5.3.2.3 , (1 00025) 5.3.2.4 , CO2 5.3.3 . 3 KS P ISO 137793 :2009 a) JCP
8、DS 09-0169 X- (tricalcium phosphate). B . 1 E . b) JCPDS 9-348 X- 2 E . c) JCPDS 9-432 JCPDS 72-1243 X- . B . 3 E . d) JCPDS 25-1137 JCPDS 70-1379 X- (tetracalcium phosphate) 4 E . e) JCPDS 4-0777 JCPDS 82-1690 X- B . 5 . 5.4 (FTIR) / . . . FTIR , 4 cm-1 4004 000 cm-1 . 6 X- 6.1 2 0.02 211 20 ( , 50
9、 ). (deconvolution) . 5 % . . 5 % . 4 KS P ISO 137793 :2009 6.2 . JCPDS 09-0169 . JCPDS 9-348 . JCPDS 9-432 JCPDS 72-1243 . JCPDS 25-1137 JCPDS 70-1379 . JCPDS 4-0777 JCPDS 82-1690 . . 0.2.10( d2.88 10-10m) 441, 170( d2.905 10-10m) 040( d2.995 10-10m) 200( d2.405 10-10m) 210 211( d 3.0810-10m d2.81
10、10-10m) . 5 ( , , , ), . , (oxyhydroxyapatite) . , , . C . 7 7.1 , ( : , ) . , . (grit-blasted) . / . . 7.2 . 5 KS P ISO 137793 :2009 7.3 X- X- , ( , ) . 40 m . . . . 8 8.1 5.3.3 . . 40 m . . . . 6. 3 X- . 8.2 8.2.1 / ( 5.3.3 ) . ( 210 211 0.2.10) X- . . 10.2.0 211 210 1=R R1 . 8.2.2 / . ( 5.3.3 ) .
11、 ( 210 211 200) (diffractogram) . . 200 211 210 2=R R2 . 6 KS P ISO 137793 :2009 8.2.3 / ( 5.3.3 ) . ( 210 211 441, 170) X- . . 170,441 211 210 3=R R3 . 8.2.4 / (5.3.3 ) . ( 210 211 040) X- . . 040 211 210 4=R R4 . 8.3 ：(Ca ： P) 8.3.1 / ( 5.3.3 ) . ( 210 211 0.2.10) X- . . 10.2.0 211 210 5=R R5 Ca :
12、 P . 8.3.2 / . ( 5.3.3 ) . ( 202 200) X- . 7 KS P ISO 137793 :2009 . 200 211 210 6=R R6 Ca : P . 9 9.1 , , . ( A). / / . ( 7. .) . , 2 30 mL 1 mL 2 mL PTFE ( ) ( ： Hg ). (110 10) 4 . 50 mL . 2 50 mL . . 3 . . 9.2 . As 1.667 : 200( d2.405 10-10 m) 9 KS P ISO 137793 :2009 202( d 2.63110-10 m) 10.5 Ca
13、: P 2 . 11 / 11.1 X- . 6. R1： R4 . 3 . . 11.2 . 6 , . 7 ( ： , , ) 100 % X- . . . 100 % . 12 12.1 X- 10 10 . D . 1 . 2 , . 12.2 7. . . 12.3 6. X- . 10, 5 % . 3 . . 10 KS P ISO 137793 :2009 12.4 ： ( 10 )100( 10 ) . . 13 KS P ISO 10993 14 . 14 KS Q ISO/IEC 17025 ( ) . . a) ( , KS P ISO 13779 3) b) c) I
14、D d) e) XRD ( ： , ), , , (apertures monochromators), f) X- g) h) 1) , ： , . 2) Ca : P 3) 4) 11 KS P ISO 137793 :2009 A () . , . , , ( ) (type) . 12 KS P ISO 137793 :2009 B () B.1 1 000 15 3 , Ca : P . a) . 0.02 ( 211)/ 50 X- d2.88 10-10m 0.2.10 d2.905 10-10 m 441, 170 . b) . 50 mL 0.2 % 0.1 mL . 100
15、 mg 15 1 000 . . . c) . . 2 mg KBr 400 mg . . 434 cm-1 , . , . (1 00025) 105Pa 15 . (84010) 15 . B.2 1 000 15 2 , . a) X- . 0.02 ( 0.2.10)/ 30 X- d 2.8110-10m 211 . b) . 2 mg KBr 300 mg KBr . . 757 cm-1 434 cm-1 1 210 cm-1, 1 185 cm-1, 723 cm-1 454 cm-1 . B.3 1 % 1 000 15 . 13 KS P ISO 137793 :2009 C () X- C.1 HA C.2 5 % TTC 14 KS P ISO 137793 :2009 C.3 5 % C.4 5 % ( TCP) C.5 5 % CaO 15 KS P ISO 137793 :2009 D () , . 100 g/g . 1 000 15 2 , Ca : P . a) . 0.02 ( 211)/ 50 X- d 2.90510-10m 441, 170 d2.88 10-10m 0.2.10 . b)
