1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 12189 KS P ISO 12189:2009 2009 12 29 http:/www.kats.go.krKS P ISO 12189:2009 : ( ) ( ) ( ) () ( ) : (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 12189:2009 . . ii 1 1 2
2、1 3 .1 4 2 5 .3 5.1 ( ).3 5.2 .4 6 7 6.1 .7 6.2 .8 6.3 ( ) .8 7 8 8 .9 9 .9 9.1 .9 9.2 .9 10 i KS P ISO 12189:2009 2008 1 ISO 12189, Implants for surgery Mechanical testing of implantable spinal devicesFatigue test method for spinal implant assemblies using an anterior support . . . , , . , , . ii K
3、S P ISO 12189:2009 Implants for surgery Mechanical testing of implantable spinal devicesFatigue test method for spinal implant assemblies using an anterior support 1 ( ) . . 2 . . ( ) . KS B ISO 10243, ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model 3 . 3.1 3
4、.2 3.3 . KS P ISO 12189:2009 3.4 3.5 , , , . 3.6 5 000 000 , 3.7 , . 3.8 3.9 UHMWPE 1 UHMWPE . 1, 2, 3 ( ) 4 . . 2 . . 4 . (UHMWPE) ( .) ( 1 ). UHMWPE . KS B ISO 10243 “ ” . ( ) ( 1 ) . 2 KS P ISO 12189:2009 1 . . : mm 1 a 1 5 5.1 () ( 1 000 mL NaCl 9 g) . ( ) . (37 2) , . 3 KS P ISO 12189:2009 KS B
5、 ISO 10243 ( ) . 5.2 , KS B ISO 10243 UHMWPE . UHMWPE UHMWPE ( 2 3 ). ASTM F1717 UHMWPE ( 76 mm, 35 mm), 3 , 2 . . , 38 mm . UHMWPE (40 3) MPa . 3 ( 1 ). L0 25 mm ext 25 mm 375 N/mm . 1 700 N/mm 2 500 N/mm ( 1 4 ). 2 KS B ISO 10243 375 N/mm . ( 4) , 147 N/mm 100 N/mm 1 . 3 KS B ISO 10243 147 N/mm .
6、KS B ISO 10243 100 N/mm . , ( ) . / . . . (UHMWPE ) . , , , . . 4 KS P ISO 12189:2009 : mm 2 UHMWPE 5 KS P ISO 12189:2009 : mm 3 UHMWPE 6 KS P ISO 12189:2009 : mm a 4 6 6.1 (5 0.1) Hz 1 . 1 kN N 2.0 60 0.6 60 0.15 4.5 0.05 4.5 7 KS P ISO 12189:2009 1 % . 6.2 ( ) . 6.3 ( ) , (37 2) ( 5.1 ). 7 7.1 (ty
7、pe) . , UHMWPE (ASTM F1717 ). 7.2 ( : 1 mm ) , . , . 7.3 ( ) . 7.4 , . (37 2) . pH ( ). . 7.5 ( 1) . . . 5 Hz( ). 1 Hz 1 100 % . 7.6 . . . 2 000 N ( 5 7 ). (semi-log) . 7.7 . a) 5 000 000 . b) ( ) c) . 7.8 2 , . . 8 KS P ISO 12189:2009 7.9 . 8 8.1 . a) . b) , , . c) , , , , . d) . e) , . f) , , . g)
8、 . h) . i) . j) , X . k) . l) . 8.2 . . 5 000 000 . 2 . . , . , , . . , . 5 000 000 . . 9 9.1 . 9.2 . 9 KS P ISO 12189:2009 10 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 12189:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryMechanical testing of implantable spinal devices Fatigue test method for spinal implant assemblies using an anterior support ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr
