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5、ce): , , , , , in vitro , , , :- , , , ;- , , , ;- , -;- ;- ;- ;- in vitro , , , - , , - .1 (Global HarmonizationTask Force GHTF).2 , :- ;- / ;- ;- ;- , , - , .3 13485, 3.7, 14971, 2.9.2.9 (residualrisk):,.1 / 51, 3.9, - .2 14971, 2.15.2.10 (risk): ./ 51, 3.22.11 (risk analysis): ./ 51, 3.10 , .2.12
6、 (risk control): - . 14971, 2.192.13 (risk estimation): , - . 14971, 2.202 560332014/ / 63:20122.14 (risk evaluation): , , . 14971, 2.212.15 (risk management): , , , - . 14971, 2.222.16 (safety): ./ 51, 3.12.17 (severity): . 14971, 2.252.18 (usability): -, , , . 62366, 3.172.19 / (use error): , , - . 1 / , . 2 . C D, D.1.3. 3 /. 62366, 3.212.20 (verification): - , . 1 . 2 :- ;- ;- ;- . 9000, 3.8.43 3.1 - , . :) ;b) , , , - ;c) , . , - , (. 4).3.2 - , , , - . ( ), , - . -3 560332014/ / 63:2012 . :- , , - ,- , ( );- , , - , , , , - ;- , , - ;