1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 7206 2 2： , KS P ISO 7206 2:2012 2012 12 27 http:/www.kats.go.krKS P ISO 7206 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 7206 2:2012 i ii . iii
2、 1 1 2 1 3 .1 4 2 4.1 2 4.2 2 4.3 3 4.4 .4 A( ) 5 A.1 5 A.2 5 KS P ISO 7206 2:2012 ii . KS P ISO 7206 2： 2007 . . , , . , , . KS P ISO 7206 2:2012 iii 2011 3 ISO 7206 2, Implants for surgery Partial and total hip joint prostheses Part 2： Articulating surfaces made of metallic, ceramic and plastics m
3、aterials . KS P ISO 7206 2:2012 2： , Implants for surgery Partial and total hip joint prostheses Part 2： Articulating surfaces made of metallic, ceramic and plastics materials 1 . a) KS P ISO 7206 1 a) b) KS P ISO 7206 1 a) , c) KS P ISO 7206 1 b) d) KS P ISO 7206 1 c) 2 . . ( ) . KS B ISO 4288, (GP
4、S) ： KS P ISO 7206 1, 1： ISO 468:1982, Surface roughness Parameters, their values and general rules for specifying requirements 3 KS P ISO 7206 1 . 3.1 (spherical pole) KS P ISO 7206 2:2012 2 4 4.1 (femoral components of total hip joint prostheses) 4.1.1 KS P ISO 7206 1 c) . 4.1.2 (sphericity) A.1 ,
5、 10 m . 4.1.3 (surface finish) ISO 4288:1996, 5.3 - ISO 4287 , Ra 0.08 mm , 0.05 m 0.02 m , Rtmax 1.0 m . . 30 . Ramax . a) b) c) Ra , . 4.1.4 (dimensional tolerances) 0.2 0 mm . 4.2 (plastics acetabular components) 4.2.1 KS P ISO 7206 1 b) . 4.2.2 (sphericity) A.2 , 100 m . 4.2.3 (surface finish) I
6、SO 4288 Ra 0.08 mm , 2 m . (acetabular) KS P ISO 7206 2:2012 3 . 5 mm . ISO 4288 0.8 mm , 2 m , . . a) b) c) Ra , . 4.2.4 (dimensional tolerance) (socket) (202) 0.1 0.3 mm ( , ). 4.3 (femoral prostheses for partial joint replacement) 4.3.1 KS P ISO 7206 1 a) . 4.3.2 (sphericity) A A.1 , 100 m . 4.3.
7、3 (surface finish) ISO 4287 , 0.08 mm , 0.5 m Ra 1.0 m Rt . . a) b) , . 4.3.4 (dimensional tolerance) 0.5 mm . KS P ISO 7206 2:2012 4 4.4 (bipolar heads) 4.4.1 . , . 4.4.2 (inner articulating surface) 4.2 . 4.4.3 (outer articulating surface) 4.3 . KS P ISO 7206 2:2012 5 A ( ) A.1 (femoral ball) (sty
8、lus) 3 . , 90 . 8 . 15 . , . 50 % . 5 3 ( A.1 ). 3 90 . 200 ( 2x100) . . 100um ( A.1 ). (square method) D O . 25 P rs . rs OP 0.5D 4.1.2 . A.2 (acetabular cup) (stylus) 3 . , 90 . . 25 . . 50 % . 5 3 ( A.2 ). 3 45 . 140 ( 2x70) . . AA , AA 1 mm . AA . (square method) D O KS P ISO 7206 2:2012 6 . 25
9、P Rs . Rs OP 0.5D 4.2.2 . 1 (P) 2 A.1 1 (P) 2 A.2 2：, 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 7206 2:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryPartial and total hip joint prosthesesPart 2： Articulating surfaces made of metallic, ceramic and plastics materials ICS 11.040.40
