GOST R ISO 13958-2015 Concentrates for haemodialysis and related therapies《血液透析及相关疗法用浓缩物》.pdf

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1、 ISO 13958:2009Concentrates for haemodialysis and related therapies(IDT) 1395820151 - ( ) - , 42 422 3 20 2015 . 149-c4 13958:2009 (ISO 13958:2009 Concentrates for haemodialysis and relatedtherapies). - , 5 1.02012 ( 8). ( 1 ) , . - () . , - (www.gost.ru) , 2015 , - - II 1395820151 12 13 24 .44.1 44

2、.2 64.3 .65 85.1 .85.2 85.3 95.4 .96 106.1 106.2 .116.3 .116.4 126.5 126.6 .126.7 13 A () . . 15 () 19 19 139582015III () - ( ). - . -, , , - . , , . -, (). /, 2. . , , - . - 75 % -, . , . - . 13958 /TC 150, , SC 2, - . 13958:2002, . , , . , , - , . - , , , . . , 13959 . , . 11663. - . , , , - . , ,

3、 - 60601-2-16. , , - /, 2. :- , ;- , , - ;- - .IV 139582015 Concentrates for haemodialysis and related therapies 201603011 , . , , , , . . , - , . , , . , , . , , - , , , . , . , . . , -. - , . 23500. - , .2 . . - ( ). 11663 (ISO 11663, Quality of dialysis fluid for haemodialysis and related therapi

4、es)1 139582015 13959 (ISO 13959, Water for haemodialysisand related therapies) 60601-1 . 1. - (IEC 60601-1, Medical electrical equipment Part 1:General requirements for basic safety and essential performance) 61010-1 , . 1. (IEC 61010-1, Safety requirements forelectrical equipment for measurement, c

5、ontrol and laboratory use Part 1: General requirements)3 :3.1 (acetate concentrate): , , - .1 .2 .3 .3.2 - (acid concentrate A-concentrate): - , - .1 ( ), .2 .3 , .3.3 (additive spike): -, - , .3.4 (batch system): , .3.5 B- (bicarbonate concentrate B-concentrate): - , - .1 .2 .3 .4 , - .3.6 (bicarbonate dialysis fluid): -, . :, , , , . 3.2, 3.5.3.7 (bulk delivery): - . , , - , . - , . .2 1395820153.8 (bulk storage tank): - , , -, .3.9 (central concentrate system): , - / -.3.10 (concentrate generator): , - , -, , . , , - , .3.11 (concentrate mixer): - .3.12 (dialysis fluid): , - , -.1 , , - .