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

2、gents). - - , 5 136402010 1.02012 ( 8). ( 1 ) , -. () . , - (www.gost.ru) , 2015 , - - II 2364020151 12 13 14 .34.1 .34.2 44.3 45 55.1 .55.2 .55.3 6 () ( ) .7 .7 236402015III - in vitro , , . (shelf life), , - . , , in vitro - . in vitro - . - in vitro . - , , .IV 236402015 IN VITRO in vitroIn vitro

3、 medical devices. Evaluation of stability of in vitro diagnostic reagents 201606011 - in vitro, , , , , - , in vitro. , , - . - -:- in vitro, , ;- in vitro . , , - ;- in vitro, ;- in vitro, . , , , , .2 : 14971 . (ISO 14971, Medical devices Application of risk management to medical devices)3 :3.1 (a

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

5、re date, expiration date): , - , , . in vitro,-, . 18113-1:2009, 3.17 in vitro (IVD medical device, in vitro medical device): -, , invitro , - , , , -, , , . 18113-1:2009, 3.27 in vitro (IVD reagent, in vitro diagnostic reagent): , - , , - in vitro. 18113-1:2009, 3.28 (shelf life): , - in vitro - ,

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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