1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 14155 2 2： KS P ISO 14155 2： 2007(2012 ) 2007 12 18 http:/www.kats.go.krKS P ISO 14155 2： 2007 : ( ) ( ) () ( ) () ( ) () () ( ) KS P ISO 14155 2： 2007 : (http:/www.standard.go.kr) ： ：2007 12 18 ：2012 12 6 20120679 ： ： (ISO/TC 194) ( 02-509-7294) (
2、http:/www.kats.go.kr). 10 5 , . KS P ISO 14155 2： 2007 i ii 1 1 2 1 3 .1 4 2 4.1 .2 4.2 (CIP)2 4.3 2 4.4 .3 4.5 3 4.6 4 4.7 4 4.8 .5 4.9 .6 4.10 .6 4.11 6 4.12 .6 4.13 7 4.14 .7 A( ) (Case Report Forms) .8 9 KS P ISO 14155 2： 2007 ii 2003 1 ISO 14155 2, Clinical investigation of medical devices for
3、human subjects Part 2： Clinical investigation plans , . EN ISO 14155 “ (Clinical investigation of medical devices for human subjects)” 2 , . , , . (Clinical Investigation Plans：CIP) . CIP , , , . CIP CIP . KS P ISO 14155 2： 2007 (2012 ) 2： Clinical investigation of medical devices for human subjects
4、 Part 2： Clinical investigation plans 1 (Clinical Investigation Plan： CIP) . CIP . . 2 . . ( ) . KS P ISO 14155 1： 2007, 1： 3 , KS P ISO 14155 1： 2007 . 3.1 (end point-primary) 3.2 (end point-secondary) 3.3 (point of enrolment) , 3.4 (follow-up period) , 3.5 KS P ISO 14155 2： 2007 2 (recruitment) 4
5、4.1 KS P ISO 14155 1 . 4.2 (CIP) CIP ( ) . CIP . CIP . , , CIP . 4.3 4.10 , , . 4.3 4.3.1 CIP . CIP / (4.3.7 ). CIP . 4.3.2 , , , / ( ) CIP ( ) , . CIP . , . 4.3.3 CIP . , . 4.3.4 CIP . 4.3.5 CIP , , , , . KS P ISO 14155 2： 2007 3 4.3.6 CIP . . 4.3.7 , ( ) ( ) CIP , . 4.4 CIP , . . a) , (traceabilit
6、y) , . CIP , . b) c) . , / . d) , ( ) , , e) f) 4.5 4.5.1 CIP / . . . . KS P ISO 14155 1： 2007 A . 4.5.2 CIP . , , , , . , , / . KS P ISO 14155 2： 2007 4 EN ISO 10993 6 . 4.5.3 CIP . . 4.5.4 CIP . . . 4.5.3 . EN ISO 14971 1 . 4.6 CIP . . a) 1 . 2 4.7(p) . b) c) 4.7 . CIP . a) ( , ) b) c) d) KS P ISO
7、 14155 2： 2007 5 e) f) , g) h) i) j) (3.3 ) k) ( ) l) , 4.8(f) 4.9 m) , 4.8(a) . . , . . n) , o) . p) . , , , , , . , ( ) . 4.8 CIP , . . a) , KS P ISO 14155 2： 2007 6 . b) / c) , d) ( ) , ( ) CIP . e) f) , , , 4.9 CIP . . . , . , , . 4.10 CIP ( ) . CIP . , . . . , , . 4.11 CIP . a) b) / / c) , , ,
8、4.12 CIP . KS P ISO 14155 2： 2007 7 . , . , CIP . 4.13 CIP . . 4.14 (Case Report Form： CRF) CIP . CRF CIP CIP . CRF , CRF . CRF , CIP CIP . CRF A . KS P ISO 14155 2： 2007 8 A ( ) (Case Report Forms) (Case Report Forms： CRF) CIP , CIP . CRF , . CRF CIP . CRF , . a) CIP (version) , b) , , c) / d) e) f
9、) / g) h) / i) j) CIP k) l) m) n) o) ( ) KS P ISO 14155 2： 2007 9 1 EN ISO 14971, Medical devices Application of risk management to medical devices(ISO 14971：2000) 2 Essential Principles Global Harmonization Task Force, 1999 3 EU Medical Devices Directive 90/385/EEC Active implantable medical device
10、s 4 EU Medical Devices Directive 93/42/EEC Medical devices 5 Guideline for Good Clinical Practice. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 1996 6 EN ISO 10993(all parts), Biological evaluation of medical devices 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 14155 2： 2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Clinical investigation of medical devices for human subjects Part 2： Clinical investigation plansICS 11.100
