KS P ISO 14155-2-2007 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans《医学受验者用医疗器械的临床调查 第2部分 临床调查设备》.pdf

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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

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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) , , ,

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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