KS P ISO 15142-2-2010 Implants for surgery－Metal intramedullary nailing systems－Part 2：Locking components《外科植入物 骨髓腔内插金属钉装置 第2部分 锁紧部件》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 151422 2： KS P ISO 151422 :2010 2010 12 24 http:/www.kats.go.krKS P ISO 151422:2010 : ( ) ( ) () ( ) : (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 151422:2010 i . KS P

2、ISO 151422：2005 . . , , . , , . KS P ISO 151422:2010 2： Implants for surgeryMetal intramedullary nailing systems Part 2：Locking components 2003 1 ISO 151422, Implants for surgeryMetal intramedullary nailing systemsPart 2：Locking components , . 1 . . 2 . . ( ) . KS P ISO 5835, KS P ISO 8319( ), KS P

3、ISO 10993( ), KS P ISO 14602, KS P ISO 14630, ISO 14971：2007, Medical devicesApplication of risk management to medical devices 3 . 3.1 (locking component) KS P ISO 151422:2010 2 , , KS P ISO 151421, 3.13 4 . a) / b) c) d) (, ) 5 . KS P ISO 10993 . ISO 14971 . . 6 . (KS P ISO 14602 ). . 7 KS P ISO 14

4、630 . ( ) . 8 KS P ISO 14602 . . 9 KS P ISO 5835 , KS P ISO 8319 . ASTM F54302 ASTM F116 . . KS P ISO 151422:2010 3 1 ASTM 1)F116, Standard Specification for Medical Screwdriver Bits 2 ASTM F54302, Standard Specification and Test Methods for Metallic Medical Bone Screws 1) (American Society for Test

5、ing and Materials) 2： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 151422 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgery Metal intramedullary nailing systems Part 2 ：Locking components ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr