1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5834 1 1: KS P ISO 5834 1: 2007(2012 ) 2007 10 31 http:/www.kats.go.krKS P ISO 5834 1: 2007 : ( ) ( ) () ( ) () ( ) () ( ) : (http:/www.standard.go.kr) : :2002 6 29 :2007 10 31 :2012 12 6 : 20120679 : (ISO/TC 150) ( 02-509-7294) (http:/www.kats.go.k
2、r). 10 5 , . KS P ISO 5834 1: 2007 (2012 ) 1: Implants for surgery Ultra-high-molecular-weight polyethylenePart 1: Powder form 2005 3 ISO 5834 1, Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form , . 1 (UHMWPE) . . 2 . . ( ) . KS M ISO 3451 1, 1: KS M ISO 11542 1: 200
3、6, (PE-UHMW) 1: KS M ISO 11542 2: 2006, (PE-UHMW) 2: ISO 1628 3, Plastics Determination of the viscosity of polymers in dilute solution using capillary viscometers Part 3: Polyethylenes and polypropylenes DIN 53474, Testing of plastics, rubber and elastomers Determination of the chlorine content (Wi
4、ckbold-combustion) 3 KS M ISO 11542 1 KS M ISO 11542 2 . 4 6. 7.1 / 1, 2 3 . KS P ISO 5834 1: 2007 2 5 . . “ ” , . 6 . 1 , 1 . 1 1 2 3 () MPa 0.2 0.42 8.1 mL/g 2 000 3 200 8.2 . 7 7.1 2 , , , , 2 . 2 mg/kg 1 2 3a() 125 40 5 30 20 125 40 5 30 20 300 150 50 90 100 8.3 8.4 8.4 8.4 8.4 a 3 . , 3 . 7.2 8
5、.5 , (30020) g 1 2 3 , 3 25 . 8 (UHMWPE) , , (light stabilizer) KS P ISO 5834 1: 2007 3 (ultraviolet: UV) . 8.1 KS M ISO 11542 2 . 8.2 ISO 1628 3 , 135 decahydronaphthalene (decalin) 0.02 % . 8.3 KS M ISO 3451 1 , 2 (70050) . 2 . 8.4 3 . 3 DIN 53474 8.5 4 1 000 mL 4 (755) g (40010) mL . . 5 , . 9 .
6、. a) b) c) d) 10 . a) KS P ISO 5834 1: 2007 4 b) c) d) e) (KS P ISO 5834 1) 1: 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ KS P ISO 5834 1: 2007 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryUltra-high- molecular-weight polyethylene Part 1:Powder form ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr