1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 6474 KS P ISO 6474:2009 2009 12 25 http:/www.kats.go.krKS P ISO 6474:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) : :2004 11 22 :2009 12 25 2009-0868 : : ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 6474:2009 .1 1 1 2 1 3 (Clas
2、sification) 1 4 (Physical and chemical properties) .1 5 (Test methods) 2 5.1 (Bulk density) .2 5.2 (Chemical composition)2 5.3 (Microstructure) 2 5.4 (Biaxial flexural strength).3 5.5 (Wear resistance).6 i KS P ISO 6474:2009 Implants for surgery Ceramic materials based on high purity alumina 1994 2
3、ISO 6474, Implants for surgery Ceramic materials based on high purity alumina . 1 , , . 2 . . ( ) . KS B ISO 3611, KS L 3114(ISO 5017), ISO 468:1982, Surface roughness Parameters, their values and general rules for specifying requirements ISO 5436:1985, Calibration specimens Stylus instruments Types
4、, calibration and use of specimens ASTM C573:1986, Method for chemical analysis of fireclay and high-alumina refractories ASTM E112:1988, Methods for determining average grain size 3 (Classification) A B . A ( ) B ( ) . 4 (Physical and chemical properties) A B 1 . KS P ISO 6474:2009 1 A , B A B g/m3
5、 3.94 3.90 5.1 : , Al2O3 , MgO , SiO2CaO % % % 99.5 0.3 0.1 5.2 : m m 4.5 2.6 7.0 3.5 5.3 MPa 250 150 5.4 a mm3 0.1 5.5 a . 5 (Test methods) 5.1 (Bulk density) KS L 3114(ISO 5017) . 5.2 (Chemical composition) ASTM C573 . ASTM C573 . 5.3 (Microstructure) 5.3.1 (Principle) , . 5.3.2 (Apparatus) 5.3.2.
6、1 , . 5.3.2.2 , 1 500 . 5.3.2.3 , 500 1 000 . 2 m (scanning optical microscope) . 5.3.3 (Preparation of test pieces) 2 KS P ISO 6474:2009 5.3.3.1 , , . 5.3.3.2 90 % . 5.3.3.3 1 400 1 500 1 4 . . 5.3.4 (Procedure) . , ASTM E112 20 , 250 . . 5.3.5 (Calculation of results) . 5.3.6 (Test report) . a) b)
7、 c) 5.4 (Biaxial flexural strength) 5.4.1 (Principle) . . 5.4.2 (Apparatus) 5.4.2.1 (Mechanical testing machine) (500 100) N/s 5 kN 1 % . ASTM E4 83 . 5.4.2.2 (Test jig) 1 . (30 0.1) mm (120.1) mm . (2 0.2) mm . 3 KS P ISO 6474:2009 0.2 mm . ( HV 500 HRC 40) . (0.6 0.1) mm 605 (shore hardness) . . 5
8、.4.2.3 (Micrometer) KS B ISO 3611 0.01 mm . 1 5.4.3 (Preparation of test pieces) 5.4.3.1 , , . 5.4.3.2 1 (36 1.0) mm, (2 0.1) mm . . 4 KS P ISO 6474:2009 5.4.3.3 10 Weibull 30 . 5.4.4 (Procedure) 5.4.3, . 5.4.6 b) . 5.4.4.1 0.1 mm 0.05 mm . . 5.4.4.2 . . . 5.4.4.3 (500 100) N/s . . 5.4.4.4 . 0.5 mm
9、(5.4.6) . . . 5.4.4.5 . 5.4.5 (Calculation of results) . )MPa(2)1(ln)1(2322l2sls2+dddvddvtF F : (N) t : (mm) ds : (mm) dl : (mm) d : (mm) v : (Poissons) (0.25 ) . 5.4.6 (Test report) . a) b) ( 5.4.3.1 ) c) (Weibull) . 0.5 mm 5 KS P ISO 6474:2009 5.5 (Wear resistance) 5.5.1 (Principle) , 1 Hz 25 . .
10、5.5.2 (Apparatus) 5.5.2.1 (Ring-on-disc oscillating test device), ( 2). 1 Hz 25 . . 2 5.5.2.2 (Profilometric test device), . . 5.5.3 (Preparation of test pieces) 5.5.3.1 , , . . 5.5.3.2 ( 3 ). : (14 ) mm (20 ) mm 0 : 25 mm 0.1 0.1 0 6 KS P ISO 6474:2009 . :mm 3 .5.3.3 . , CLA: 0.10 m : 0.6 m ISO 543
11、6 ISO 468 . .5.4 (Procedure) .5.4.1 . .5.4.2 . : 25 ) N h .5.4.3 . .5.4.4 3 mm 3 mm .5.4.5 5 . 555 : (1 50010: (10.1) Hz : (1001) : :, 5. . . . 5 . . 5 . . . 7 KS P ISO 6474:2009 . . 5.5.5 . V . (mm2) (mm) 5.5.6 . ) , (Calculation of wear volume) 5.5.5.1 6 5.5.5.2 V (rori )A A : ro :ri : (mm) (Test
12、report) a) (5.5.3.1) bc) d) e) f) 5 8 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 6474:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryCeramic materials based on high purity alumina ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr