1、 141552014 ISO 14155:2011Clinical investigation of medical devices for human subjects Good clinicalpractice(IDT) 1 ( ) , 42 436 - 3 4 2014 . 497-4 14155:2011 . (ISO 14155:2011 Clinical investigation ofmedical devices for human subjects Good clinical practice), ISO 14155:2011/Cor.1:2011. - 1.5 ( 3.5)
2、 - - , 5 14155-12008, 14155-22008 1.02012 ( 8). ( 1 ) , -.() - . , - (gost.ru) , 2015 , - - II 1415520141 .12 13 14 64.1 64.2 .64.3 64.4 .64.5 .64.6 .74.7 .75 105.1 .105.2 .105.3 115.4 .115.5 () 115.6 .115.7 .125.8 125.9 () 125.10 125.11 .126 .126.1 .126.2 .126.3 .126.4 .136.5 .136.6 136.7 - 136.8
3、146.9 .146.10 156.11 157 , .167.1 167.2 .167.3 17III 1415520147.4 .178 188.1 188.2 188.3 .228.4 .229 229.1 .229.2 .229.3 .239.4 239.5 .239.6 IP .239.7 249.8 24 () .25 () () 29 () 31 D () .33 () 36 F () .43 () .4546IV 141552014 () - ( ). . -, - , , - . , , . , (). - /, 2. . , , -. 75 % -, . , . - .
4、14155:2011 /T 194 . 14155:2011/Cor.1:2011, - 14155-12008 14155-22008.V 141552014 Clinical investigations. Good clinical practice 201506011 , -, , - , ., , , , , - . , :- ;- ;- ;- , , , , . in vitro . , /T 194, - . , - () () .2 : 14971:2007 . - (ISO 14971:2007, Medical devices Application of risk man
5、agement to medical devices)3 :3.1 () ; ADE (adverse device effect; ADE): , . 1 , , , , , - . 2 , .1 141552014 3.2 () ; AE (adverse event; AE): , , - , , , . 1 , - . 2 , . 3 , .3.3 (audit): , , , , CIP, - , .3.4 / (blinding/masking): , , . , () () - . , (), (), () , , .3.5 ; CRF (case report forms; C
6、RF): , , CIP , .3.6 (clinical investigation): - , . .3.7 ; CIP (clinical investigation plan; CIP): , , , () , , . CIP. , , . . CIP.3.8 (clinical investigation report): , () , .3.9 (clinical performance): - () - , () () .3.10 (comparator): , - (, ), , .3.11 ; CRO (contract research organization; CRO)
7、 , , .3.12 - (coordinating investigator):,- .3.13 ; DMC (data monitoring committee; DMC): , , - , .2 141552014 DMC (data safetymonitoring board, DSMB) (data safety monitoring committee,DSMC).3.14 (deviation): () , , - CIP.3.15 (device deficiency): - , , , , . , -.3.16 () endpoint(s): (), () .3.17 () () endpoint(s): (), () - .3.18 ; (ethics committee; EC): , - , .
