KS P ISO 5834-2-2012 Implants for surgery－Ultra-high molecular weight polyethylene－Part 2：Moulded forms《外科植入物 超高分子量聚乙烯 第2部分 模塑型》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5834 2 2： KS P ISO 5834 2:2012 2012 12 27 http:/www.kats.go.krKS P ISO 5834 2:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 29 ：2012 12 27 2012-0767 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5834 2:2012 i . , , . ,

2、, . KS P ISO 5834 2:2012 ii 2011 4 ISO 5834 2, Implants for surgery Ultra-high molecular weight polyethylene Part 2： Moulded forms . KS P ISO 5834 2:2012 2： Implants for surgery Ultra-high molecular weight polyethylenePart 2： Moulded forms 1 (PE UHMW) . . 2 . . ( ) . KS M ISO 527 1:2007, 1： KS M ISO

3、 1183:2006, KS M ISO 3451 1:2007, 1： KS P ISO 5834 1, 1： KS M ISO 11542 1:1998, (PE UHMW) 1： 3 KS P ISO 5834 1 1, 2 3 1, 2 3 . 4 KS P ISO 5834 1 . 5 (lot number) . “ ” . KS P ISO 5834 2:2012 2 . , (migration) (： , ). 6 6.1 1 , 1 . . 6.2 7.8 10 . 1 1 2 3 () kg/m3927944 927944 927944 7.2 amg/kg 150 15

4、0 300 7.3 b, BMPa 21 19 19 7.4 b, RMPa 35 27 27 7.5 b, R% 300 300 250 7.6 Charpy aCNkJ/m2180(126) 90(73) 30(25) 7.7 a , . . 20 mg/kg . b , .7 (UHMWPE) . 7.1 , 7.2 7.4 7.7 (232) , 16 . 7.2 KS P ISO 5834 2:2012 3 KS M ISO 1183： 2006 A( ) 3 . 3 1 . 7.3 KS M ISO 3451 1 , 2 (70050) . 1 . 7.4 KS M ISO 527

5、 1 (1.50.5) mm 5 (10010) mm/ . 1 . 7.5 7.4 . 1 . 7.6 7.4 . 1 . 7.7 KS M ISO 11542 2:2006(Charpy) B ASTM F 648(Izod) . ISO11542 2 . 7.8 (500103) mm2 . , , . 8 ID ID . . 9 . . a) ( , KS P ISO 5834 2:2012) b) , 1, 2, 3 c) KS P ISO 5834 2:2012 4 d) e) f) 10 . KS P ISO 5834 2:2012 5 1 ISO 11542 1, Plasti

6、cs Ultra-high-molecular-weight polyethylene(PE-UHMW) moulding and extrusion materials Part 1: Designation system and basis for specifications 2 ASTM F648:2007, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants 2： 153787 1 92 3(16) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 5834 2:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryUltra-high molecular weight polyethylene Part 2：Moulded forms ICS 11.040.40