1、 KS P ISO 15539KSKSKSKSSKSKSKS KSKSKS SKSKS KSKS SKS KS KS P ISO 15539： 2007 (2012 ) 2007 10 31 http:/www.kats.go.krKS P ISO 15539： 2007 : ( ) ( ) () ( ) () ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 29 ：2007 10 31 ：2012 12 6 ： 20120679 ： (ISO/TC150) ( 02-509-7294) (http:/www.kats.go.kr). 10
2、5 , . KS P ISO 15539： 2007 i 1 1 2 1 3 .2 4 3 5 3 6 3 7 3 8 .3 9 .3 9.1 .3 9.2 .3 9.3 .4 10 .4 10.1 .4 10.2 .4 11 .4 A( ) 5 B( ) 11 C( ) 15 D( ) 17 19 KS P ISO 15539： 2007 (2012 ) Cardiovascular implantsEndovascular prostheses 2000 1 ISO/TS 15539, Cardiovascular implants Endovascular prostheses , .
3、1 1.1 . , . ISO 14630 . 1.2 (： ) , . a) b) c) (： , ) d) e) (： , ) f) g) h) i) j) 1.3 , . ISO 14630 . 1.4 (3.13.4 ). A B , . C . D . 2 KS P ISO 15539： 2007 2 . . . , . IEC ISO . KS P ISO 11134, KS P ISO 11135, KS P ISO 11137, KS P ISO 13485, ISO 9001 KS P ISO 14630, ISO 11607： 2003, Packaging for ter
4、minally sterilized medical devices ISO 13488： 1996, Quality systems Medical devices Particular requirements for the application of ISO 9002 ISO 14160： 1998, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid
5、chemical sterilants ISO 14937： 2000, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971 1： 1998, Medical devices Risk management EN 556, St
6、erilization of medical devices Requirements for terminally sterilized devices to be labelled “Sterile” 3 KS P ISO 14630 . 3.1 , 1 . (3.2), (3.3), (3.4) 2 . 3.2 , , “ ” . 3.3 KS P ISO 15539： 2007 3 3.4 4 KS P ISO 14630 4. . 5 KS P ISO 14630 5. . A B . 6 KS P ISO 14630 6. . 7 KS P ISO 14630 7. . ISO 1
7、4971 1 . A B . 8 KS P ISO 13485, ISO 13488, KS P ISO 14630 8. . 9 9.1 9.1.1 “ ” EN 556, , 10 6 . 9.1.2 . 9.1.3 (ethylene oxide) KS P ISO 11135 . 9.1.4 KS P ISO 11134 . 9.1.5 KS P ISO 11137 . 9.1.6 ISO 14160 . 9.1.7 ISO 14937 . . 9.2 KS P ISO 15539： 2007 4 KS P ISO 14630 9.2 . 9.3 KS P ISO 14630 9.3
8、. 10 10.1 KS P ISO 14630 10.1 . 10.2 10.2.1 “ ” , , , . 10.2.2 ISO 11607 . . 11 KS P ISO 14630 11. . A B . KS P ISO 15539： 2007 5 A ( ) A.1 A.3 , , , . B C . D . A.1 . . A.1 1 / (1 ) . 2 (1 ) (2 ) . 3 (2 ) , (3 ) . 4 (1 ) ： (4 ) 5 (1 ) (5 ). 6 (1 ) (6 ). 7 (2 ) (3 ) , (7 ) . KS P ISO 15539： 2007 6 A
9、.2 / (1) (2) (3) (4) (5) (6) (7) / (3) . ： . ： KS P ISO 15539： 2007 7 A.2 ( ) / (1) (2) (3) (4) (5) (6) (7) ： / ： / ISO 10993 ISO 10993 N/A N/A KS P ISO 15539： 2007 8 A.3 / (1) (2) (3) (4) (5) (6) (7) , , , , / / , , , , N/A KS P ISO 15539： 2007 9 A.3 ( ) / (1) (2) (3) (4) (5) (6) (7) N/A , , / , N/
10、A , , , , / , , , , N/A KS P ISO 15539： 2007 10 A.3 ( ) / (1) (2) (3) (4) (5) (6) (7) (MRI) MRI N/A MRI ISO 10993 ISO 10993 N/A KS P ISO 15539： 2007 11 B ( ) B.1 B.4 , , , . C . D , . B.1 . . B.1 1 / (1 ) .2 (1 ) (2 ) .3 (2 ) (3 ) .4 (1 ) . (4 ) 5 (1 ) (5 ). 6 (1 ) (6 ). 7 (2 ) (3 ) (7 ) . KS P ISO 15539： 2007 12 B.2 / (1) (2) (3) (4) (5) (6) (7) . N/A ISO 10993 ISO 10993 N/A KS P ISO 15539： 2007 13 B.3 / (1) (2) (3) (4) (5) (6) (7) N/A N/A N/A N/A ISO 10993 ISO 10993 N/A KS P ISO 15539： 2007 14 B.4 / (1) (2) (3) (4) (5) (6) (7)
