1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO TR 14283 KS P ISO TR 14283:2009 2009 1 6 http:/www.kats.go.krKS P ISO TR 14283:2009 : ( ) ( ) () ( ) : () ( ) () ( ) : (http:/www.standard.go.kr) ： ：2003 12 19 ：2009 1 6 2009-0003 ： ： ( 025097266) (http:/www.kats.go.kr). 10 5 , . KS P ISO TR 14283:2
2、009 i ii .1 1 1 2 .1 3 .2 4 .3 4.1 , , .3 4.2 .4 4.3 .4 4.4 5 4.5 .5 4.6 6 4.7 6 4.8 .7 4.9 8 A( ) .10 A.1 .10 A.2 .10 A.3 .10 A.4 .10 A.5 .10 A.6 .11 16 KS P ISO TR 14283:2009 ii . KS P ISO TR 14283： 2003 . . , , . , , . KS P ISO TR 14283:2009 Implants for surgery Fundamental principles 2004 2 ISO/
3、TR 14283, Implants for surgery Fundamental principles . 1 . 2 . 2.1 (accessory) . 2.2 (active medical device) . . 2.3 (intended purpose) , / . 2.4 (labelling) , . KS P ISO TR 14283:2009 2 KS P ISO 13485 “ ” “ ” . 2.5 (manufacturer) , , . 2.6 (medical device) , , , . , , , , , , , , . 2.7 (medicinal
4、product) . 2.8 (implant) (epithelial surface) 30 . 3 3.1 , , . KS P ISO TR 14283:2009 3 3.2 . . a) ( ). b) ( ) . c) . 3.3 , 3.1 , , . 3.4 , 3.1, 3.2 3.3 . 3.5 , . 3.6 .4 4.1 , , 4.1.1 3. “ ” . . a) , b) , 4.1.2 , , , . . 4.1.3 , , . , . 4.1.4 2.7 , . 4.1.5 . 4.1.6 KS P ISO TR 14283:2009 4 . 4.1.7 .
5、4.2 4.2.1 . . 4.2.2 . . , , . . 4.2.3 , , . 4.2.4 . 4.2.5 . 4.2.6 , . . 4.2.7 / . 4.3 4.3.1 . . 4.3.2 . a) / , b) , , , , c) (defibrillator) KS P ISO TR 14283:2009 5 d) . . 4.3.3 . “ ” . . 4.4 4.4.1 . . 4.4.1.1 . 4.4.1.2 . 4.4.2 KS A ISO 31 . 4.5 4.5.1 , . 4.5.2 4.5.2.1 , . 4.5.2.2 / . 4.5.3 , , . 4
6、.5.4 KS P ISO TR 14283:2009 6 , . 4.6 4.6.1 , . 4.6.2 . 4.6.3 . 4.7 4.7.1 4.7.1.1 , . / . 4.7.1.2 . 4.7.1.3 , . . 4.7.1.4 , . 4.7.1.5 . 4.7.2 4.7.2.1 . “ ” . 4.7.2.2 , . 4.7.3 4.7.3.1 , KS P ISO TR 14283:2009 7 . 4.7.3.2 . 4.7.3.3 , . 4.7.3.4 , . 4.7.4 4.7.4.1 . 4.7.4.2 . 4.7.4.3 . 4.7.4.4 . 4.8 4.8
7、.1 . . . . . 4.8.2 . . . 4.8.3 . a) b) KS P ISO TR 14283:2009 8 c) “STERILE” d) “LOT” “SN” e) f) ( ) g) ( “ ” “ ” ) h) i) j) k) l) 4.8.4 . 4.8.5 . 4.8.6 . a) d), e), k) 4.8.3 b) 3.3 c) d) e) f) g) h) , 3. . i) , j) . . k) l) , , , , , , m) n) o) 4.1.4 p) 4.9 KS P ISO TR 14283:2009 9 3.6 . . a) b) KS
8、 P ISO TR 14283:2009 10 A ( ) A.1 A.1 2003 9 1 / . . . / . . A.2 a) 1993 6 14 93/42/EEC： , Vol 35, L 169, 1993 7 12 b) 1990 6 20 90/385/EEC： , Vol 33, L 189, 1990 7 20 A.3 (Theraputic Goods Regulations) Theraputic Goods(Medical Devices) Regulations 2002, Schedule 1 . A.4 “ ” . “MDR” (SIII III ). “SG
9、MDR” MDR Part V ( 3 “ ” ). “CAN/CSA” CAN/CSA C22.2 No 601.1 M90 1994 1 13 , VII . 1994 1 13 VII P.C. 1994 63 . (C22.2) . C22.2 No. 601.1 IEC 60601 1 2 . A.5 KS P ISO TR 14283:2009 11 YY0340 (Implants for Surgery Fundamental Principles, YY0340 2002, , KS P ISO/TR 14283： 2003 , 2003 4 1 ) . YY0341 (Ge
10、neral Technological Requirements for Non active Metallic Surgery Implants for Osteosynthesis YY0341 2002, , GB 12417 90, 2003 4 1 ) . Y30 (Provision for Administrations of Medical Devices Instructions for Use, 2002 5 1 ) . A.6 “The Law” (the Pharmaceutical Affairs Law, , 2001 6 1 ) . Act 14 , Act 19 2 , Act 63 Act 63 2 Act 64 Act 74 2 , Act 75 2 , Act 77 5 Act 77 6 “GMP” (the Regulation of Manufacturing and Quality Control of Medical Devices) . “GCP” (the Standard for Clinical Investigation of Medical Devices.) . 3
