1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5834 5 5: KS P ISO 5834 5: 2007(2012 ) 2007 12 18 http:/www.kats.go.krKS P ISO 5834 5: 2007 : ( ) ( ) () ( ) () ( ) () ( ) : (http:/www.standard.go.kr) : :2007 12 18 :2012 12 6 20120679 : : (TC 150) ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . K
2、S P ISO 5834 5: 2007 i .1 1 1 2 1 3 .1 4 , 2 5 2 6 .2 7 2 8 2 8.1 2 8.2 2 8.3 .3 8.4 .3 6 KS P ISO 5834 5: 2007 (2012 ) 5: Implants for surgery Ultra-high-molecular-weight polyethylenePart 5: Morphology assessment method 2005 1 ISO 5834 5, Implants for surgery Ultra-high-molecular-weight polyethylen
3、e Part 5: Morphology assessment method , . 1 KS P ISO 5834 2 UHMWPE . KS P ISO 5834 1 UHMWPE . 2 . . ( ) . KS M ISO 11542 1: 2006, (PE UHMW) 1: KS M ISO 11542 2: 2006, (PE UHMW) 2: KS P ISO 5834 1: 2007, 1: 3 KS M ISO 11542 1, KS M ISO 11542 2 . 3.1 A (Type A non-fused flake) 8.3.2 ( 1 ) 3.2 B (Type
4、 B non-fused flake) KS P ISO 5834 5: 2007 2 50 99 % , 8.3.2 ( 2 ) 3.3 (Morphology Index: MI) . , cm2 A B . AreaBTypeATypeMI+= 3.4 (lot) . 4 , KS P ISO 5834 1 1 , 2 3 1 , 2 3 . 5 KS P ISO 5834 1 UHMWPE . 6 . . . 7 . 8 UHMWPE , . 8.1 (UHMWPE) . UHMWPE UHMWPE . UHMWPE UHMWPE ( ) . 8.2 KS P ISO 5834 5:
5、2007 3 (10050) m . ( ) . . , . , 0.5 mm . 2 cm2 8.3.2 . 8.3 (10050) m . , , . . 8.3.1 . 8.3.2 40 . , A , B . 100 A B . 100 A B . 100 UHMWPE . 8.4 . a) A b) B c) cm2 d) (3.3) KS P ISO 5834 5: 2007 4 a) b) 1 A KS P ISO 5834 5: 2007 5 a) b) 2 B KS P ISO 5834 5: 2007 6 1 KS P ISO 5834 2, 2: 2 ASTM F 648
6、, Standard specification for ultra-high-molecular-weight polyethylene powder and fabricated form for surgical implants 5: 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 5834 5: 2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgery Ultra-high-molecular-weight polyethylene Part 5: Morphology assessment method ICS 11.040.40