1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8828 KS P ISO 8828:2008 2008 11 7 http:/www.kats.go.krKS P ISO 8828:2008 : ( ) ( ) ( ) ( ) : ( ) ( ) ( ) ( ) : (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 8828:2008 i .
2、 KS P ISO 8828： 2003 . . , , . , , . KS P ISO 8828:2008 Implants for surgery Guidance on care and handling of orthopaedic implants 1988 1 ISO 8828, Implants for surgery Guidance on care and handling of orthopaedic implants . 1 ( , ) . . 2 . 2.1 (orthopaedic implant) , / 1 “ ” “ ” . 2 “ ” . 3 3.1 3.1
3、1 . a) (3.1.2 ) KS P ISO 8828:2008 2 b) (3.1.3 ) 3.1.2 . . . , . 3.1.3 . . . 3.1.4 . . 3.2 . 3.3 3.3.1 , , . 3.3.2 , . . 3.3.3 . a) b) c) d) e) f) 3.4 KS P ISO 8828:2008 3 3.4.1 . . 3.4.2 . , , , , . 3.5 “ ” . , . 3.6 3.6.1 . 3.6.2 , . , . , , . 3.6.3 . , . 3.6.4 , . , . . 3.6.5 . 3.6.6 . 3.6.7 , ,
4、 . . 3.7 . 3.8 3.8.1 . 3.8.2 . , , V . KS P ISO 8828:2008 4 3.8.3 . 3.9 . 4 4.1 . . , , . . 4.2 2 ( , , ) . 4.3 , , , , , . . 5 5.1 . , . , . . 5.2 . 5.3 . 6 6.1 KS P ISO 8828:2008 5 . . 6.2 , . 6.3 . , . 7 . ISO 6018, Orthopaedic implants General requirements for marking, packaging and labelling AS
5、TM F 565, Standard practice for care and handling of orthopedic implants and instruments 135513 7017 (02)60094114 (02)600948878 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 8828:2008 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Implants for surgeryGuidance on care and handling of orthopaedic implants ICS 11.040.40
