KS P ISO 10334-2010 Implants for surgery－Malleable wires for use as sutures and other surgical applications《外科植入物 作为缝合用和其他外科用金属丝》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10334 KS P ISO 10334 :2010 2010 12 24 http:/www.kats.go.krKS P ISO 10334:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2005 12 28 ：2010 12 24 2010-0626 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 10334:2010 i . KS P ISO 103

2、34：2005 . . , , . , , . KS P ISO 10334:2010 Implants for surgeryMalleable wires for use as sutures and other surgical applications 1994 1 ISO 10334, Implants for surgeryMalleable wires for use as sutures and other surgical applications , . 1 . , . . 1 , . 2 . , D E (KS P ISO 58321 ) , . . 2 . . ( )

3、. KS B ISO 7800, KS B ISO 7801, KS P ISO 58321, 1： KS P ISO 58322, 2： KS P ISO 58325, 5： KS P ISO 58329, 9： ISO 6018：1987, Orthopaedic implantsGeneral requirements for marking, packaging and labelling KS P ISO 10334:2010 2 ISO 6892, Metallic materialsTensile testing ASTM F 8691, Standard Practice fo

4、r Surface Preparation and Marking of Metallic Surgical Implants 3 KS P ISO 58321 D E , KS P ISO 58322 , KS P ISO 58329 KS P ISO 58325 . 4 . ASTM F 86 . 5 (8. ). 1, 2, 3, 4 . 6 6.1 8. 1, 2, 3, 4 . 6.2 , KS B ISO 7801 5 . . 6.3 , KS B ISO 7800 , 5 . . . 1 KS P ISO 58321 mm MPa % 0.10.199 005 . 0 895 3

5、0 0.20.299 5 007 . 0 860 30 0.30.599 01 . 0 825 30 0.60.799 013 . 0 790 35 0.81.099 02 . 0 760 35 1.11.6 025 . 0 690 40 KS P ISO 10334:2010 3 2 KS P ISO 58322 mm MPa % 0.1250.249 013 . 0 10 0.250.749 025 . 0 10 1 0.751.6 05 . 0 400 12 0.1250.249 013 . 0 8 0.250.749 025 . 0 8 2 0.751.6 05 . 0 490 10

6、0.1250.249 013 . 0 6 0.250.749 025 . 0 6 3 0.751.6 05 . 0 580 8 0.1250.249 013 . 0 4 0.250.749 025 . 0 4 4 0.751.6 05 . 0 680 6 3 KS P ISO 58325 mm MPa % 0.10.199 005 . 0 1 450 35 0.20.299 5 007 . 0 1 380 40 0.30.599 01 . 0 1 310 40 0.60.799 013 . 0 1 240 45 0.81.099 02 . 0 1 170 45 1.11.6 025 . 0 1

7、 140 45 4 KS P ISO 58329 mm MPa % 0.10.199 005 . 0 1 370 15 0.20.299 5 007 . 0 1 300 20 0.30.599 01 . 0 1 230 20 0.60.799 013 . 0 1 160 25 0.81.099 02 . 0 1 100 25 1.11.6 025 . 0 1 070 25 KS P ISO 10334:2010 4 5 mm 0 a 0.150.299 40 20 10 0.30.799 40 15 7.5 0.81.099 30 12 6 1.11.6 30 4 2 a . 7 ISO 60

8、18 . . . , . 8 6 . ISO 6892 . 6 6.1 ISO 6892 ISO 6892 6.2 KS B ISO 7801 6.3 KS B ISO 7800 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 10334 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgery Malleable wires for use as sutures and other surgical applications ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr