1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 5835 KS P ISO 5835:2008 2008 11 7 http:/www.kats.go.krKS P ISO 5835:2008 : ( ) ( ) ( ) ( ) : ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2003 12 19 ：2008 11 7 2008-0746 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 5835:2008 i ii
2、.1 1 1 2 1 3 1 4 1 4.1 .2 4.2 (HB).4 5 .5 A( ) 6 B( ) , 8 C( ) ： B .9 KS P ISO 5835:2008 ii . KS P ISO 5835： 2003 . . , , . , , . KS P ISO 5835:2008 Implants for surgery Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions 1991 1 ISO 5835
3、, Implants for surgery Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions , . 1 (bone screw) . 1 KS P ISO 6475 . 2 , B . 2 . . ( ) . KS P ISO 6475, ISO 6018： 1987, Orthopaedic implants General requirements for marking, packaging and lab
4、elling 3 . a) ( ) HA b) (/ ) HB 4 (mm) . KS P ISO 5835:2008 2 4.1 HA 1, 2 1, 2 . a 60 . 1 (HA) 1 HA d2 d1k - r10.25 0 r2-r3- SW F10at 0.10 0.10HA 1.5 HA 2.0 HA 2.7 HA 3.5 HA 4 HA 4.5 HA 5 1.5 2 2.7 3.5 4 4.5 5 3 4 5 6 6 8 8 0.10 0.151.6 1.9 2.3 2.6 2.4 4.6 4.6 1.5 2 2.5 3 3 4 4 1.5 2 2.5 2.5 2.5 2.5
5、 2.5 0.3 0.4 0.4 1 1 1 1 1.5 1.5 2.5 2.5 2.5 3.5 3.5 0.8 1.0 1.2 1.5 1.5 2.8 2.8 aSW 3 mm F10+007.0047.0SW 3 mm F10+010.0058.0a KS P ISO 5835:2008 3 2 (HA) 2 HA d5 d1 0.15 0.15 e P r4r5 0 0.10 HA 1.5 HA 2.0 HA 2.7 HA 3.5 HA 4 HA 4.5 HA 5 1.5 2 2.7 3.5 4 4.5 5 1.1 1.3 1.9 2.4 2.9 3 3.5 0 0.15 0.1 0.1
6、 0.1 0.1 0.1 0.1 0.1 0.5 0.6 1 1.25 1.5 a, b1.75 1.75 0.3 0.4 0.6 0.8 0.8 1 1 0.1 0.1 0.2 0.2 0.2 0.3 0.3 35o35o35o35o35o35o35o3o3o3o3o3o3o3oa ： d1, d5,e, r4,r5, . . HA 1.5 HA 2 0.050 mm HA 2.7 HA 5 0.075 mm . bHB 4 1.75 mm HA 4 1.5 mm ( 4 ). KS P ISO 5835:2008 4 4.2 (HB) HB 3, 4 3, 4 . 3 (HB) 3 HB
7、d1d2 0.150.15d4 0.150.15k r10.25 0.25r2SW F10at HB 4 HB 6.5 4 6.5 6 8 2.4 4.5 2.9 4.6 3 4 2.5 2.5 2.5 3.5 1.5 2.8 aSW 3 mm F10+007.0047.0SW 3 mm F10+010.0058.0 KS P ISO 5835:2008 5 4 (HB) 4 HB d1 0.15 0.15 d5 0.150.15e P r4r5 HB 4 HB 6.5 4 6.5 1.9 3 0.1 0.2 1.75 a, b2.75 0.8 1.2 0.3 0.8 25o25o5o5oa
8、2 b b ： d1,d5,e, r4,r5, . . HB 0.075 mm . 5 ISO 6018 . KS P ISO 5835:2008 6 A ( ) KS P ISO 9268 7 6 2 2 HA 4.5 ( A.1, A.2 A.1, A.2 ). , , KS P ISO 9268 , KS P ISO 6475 . A.1 A.1 A.1 d1d2 0.15 0.15 k r 4.5 8.0 3.8 5.5 KS P ISO 5835:2008 7 A.2 A.2 A.2 d b n 5.0 3.8 1.4 KS P ISO 5835:2008 8 B ( ) , , 2
9、 . 2 (HA HB HC HD ). 2 , . KS P ISO 9268 KS P ISO 5835 KS P ISO 6475 / KS P ISO 5836 KS P ISO 9269 KS P ISO 9585 KS P ISO 9585 KS P ISO 8319 1 KS P ISO 8319 2 , , KS P ISO 9714 1 KS P ISO 5835:2008 9 C ( ) ： B 1 KS P ISO 5835, 2 KS P ISO 5836, 3 KS P ISO 6475, 4 KS P ISO 8319 1, 1： 5 KS P ISO 8319 2
10、, 2： , 6 KS P ISO 9268, 7 KS P ISO 9269, 8 KS P ISO 9585, 9 KS P ISO 9714 1, 1： , 135513 7017 (02)60094114 (02)600948878 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 5835:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryMetal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions ICS 11.040.40
