GOST R ISO 23640-2015 In vitro medical devices Evaluation of stability of in vitro diagnostic reagents《体外医疗器械 体外诊断试剂的稳定性评估》.pdf

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1、 IN VITRO in vitroISO 23640:2011In vitro medical devices Evaluation of stability of in vitro diagnostic reagents(IDT) 2364020151 - - - . . , 42 380 - in vitro3 - 27 2015 . 301-4 23640:2011 - in vitro. in vitro (ISO 23640:2011In vitro medical devices Evaluation of stability of in vitro diagnostic rea

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4、ccelerated stability evaluation): , - / in vitro .1 236402015 - , , .3.2 (Arrhenius plot): , - - .3.33.43.53.63.73.8 (real time stability evaluation): , in vitro . , in vitro,- , , , .3.92 236402015 (batch, lot): , - . 18113-1:2009, 3.5 (batch code, lot number): / , - , , - . 18113-1:2009, 3.6 (expi

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6、. (3.10) (3.5) . 18113-1:2009, 3.663.103.11 (verification): .1 , , , .2 , - .3 , - in vitro.4 , .1 , , .2 , , - .3 1, 3.73.4 4.1 , , in vitro, -, . / , - in vitro, , . - , , - . in vitro -, -. in vitro, , . in vitro , - .3 236402015 (stability): in vitro , .1 :- in vitro, , - , ;- , , - , - .2 in vitro - :- , - ;- . 18113-1:2009, 3.68 , , - , . - . - .4.2 in vitro , , :- ;- in vitro;- .1 , ;- ;- .2 , , , ;- . ;- , .3 2 8 , 20 ;- ;- ;- , .4 ;- , in vitro,- ( , - in vitro);- , ;- .5 ;- , ;- . , - in vitro.4.3 ,

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