KS P ISO 13959-2009 Water for haemodialysis and related therapies《血液透析用水和有关疗法》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 13959 KS P ISO 13959:2009 2009 12 25 http:/www.kats.go.krKS P ISO 13959:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 25 2009-0866 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 13959:2009 .1 1 1 2 .1 3

2、(Dialysis water requirements) 3 3.1 (Dialysis water verification and monitoring) .3 3.2 (Microbiological requirements).3 3.3 (Chemical contaminants) .3 4 , (Tests for compliance with chemical and microbiological requirements)4 4.1 (Microbiology of product water) 4 4.2 (Chemical contaminants test met

3、hods) .4 A( ) .6 A.1 (Microbiology of dialysis water) 6 A.2 (Chemical contaminants test methods) .6 10 i KS P ISO 13959:2009 Water for haemodialysis and related therapies 2009 2 ISO 13959, Water for haemodialysis and related therapies . 1 , , . . . . 2 . 2.1 (action level) , 2.2 , (chlorine, total)

4、( ) ( ) . . 2.3 (colony forming unit) CFU . KS P ISO 13959:2009 2.4 (dialysis fluid) ( ) 1 “ (dialysing fluid)” . 2 “ (fresh dialysing fluid)” “ (spent dialysing fluid)” . 2.5 (dialysis water) , 2.6 (endotoxin) (gram) A . , , , , ( 2.12 ). 2.7 (endotoxin units) EU LAL( Limulus amoebocyte lysate) 1 .

5、 2 (IU) . 1983 , EU IU . 2.8 (feed water) 2.9 LAL (Limulus amebocyte lysate test) LAL test (Limulus polyphemus) . 2.10 (microbial) , , . 2.11 (microbial contamination) (： , , ) , (2 KS P ISO 13959:2009 ) 2.12 (pyrogen) . 3 (Dialysis water requirements) 3.1 (Dialysis water verification and monitoring

6、) 3.2 3.3 . . 3.2 (Microbiological requirements) 100CFU/mL . . 50 % . 0.25 EU/mL . 50 % . A.1 3.3 (Chemical contaminants) 1 2 . 1 mg/L 0.01 0.1 0.1 0.2 0.005 (N) 2 100 0.1 2(0.05 mmol/L) 4(0.15 mmol/L) 8(0.2 mmol/L) 70(3.0 mmol/L) 3 KS P ISO 13959:2009 2 mg/L 0.006 0.005 0.1 0.000 4 0.001 0.014 0.00

7、0 2 0.09 0.005 0.002 ( , ), . 4 , (Tests for compliance with chemical and microbiological requirements) 4.1 (Microbiology of dialysis water) , . 4 24 . ( ) ( , , ) . . (TGEA), 2A (R2A), . . 17 23 168 (7) . . , . LAL(Limulus Amoebocyte Lysate) . . 4.2 (Chemical contaminants test methods) 1 , , / . 2

8、3 . 4 KS P ISO 13959:2009 , 2 , / . 2 , (WHO) . 0.1 mg/L . , 2 (WHO)( 51 ) , TDS 90 % . . 3 . 3 , () , #3113 ( ) , #200.9 ( ) , #3114 () , #3113 ( ) , #200.9 () , #3113 EDTA ( ) ( ) , #3500-Ca D , #3111B DPD DPD , #4500-Cl F , #4500-Cl G () , #3113 ( ) , #3111 , #3500-Cu D SPADNSsodium 2-(parasulfop

9、henylazo)-1,8-dihydroxy-3,6-naphthalenedisulfonate , #4500-F-C , #4500-F-D () , #3113 ( ) ( ) , #3111 ( ) , #3112 , #4500-NO3E ( ) ( ) , #3111 , #3500-K D , #3500-K E ( ) , #3114 , #3113 ( ) , #3113 ( ) ( ) , #3111 , #3500-Na D , #4500-SO E24 ( ) , #200.9 , 2.4.8 , ( ) , #3111 , #3500-Zn D5 KS P ISO

10、 13959:2009 A () A.1 (Microbiology of dialysis water) . . . 1982 AAMI 200 CFU/mL . , (EC) 100 CFU/mL , . 7 , . . . , , , , . ( ) . . AAMI 2 EU/mL , , . EC 0.25 EU/mL . 2008 0.25 EU/mL . A.2 (Chemical contaminants test methods) . 3 . . , , , , , , . 1 mg/L . . 8 1 . 1 6 KS P ISO 13959:2009 50 mg/L .

11、. 15 12 3 . 22.5 mg/L . . . . . , . . . . 2008 0.1 mg/L . 200 mg/L , . 100 mg/L . . . (EPA) . . 52 g/L 65 g/L . 5 g/L . 3.3 1 . , , . , 10 mg/L 2 mg/L . 10 mg/L 20 % 2 mg/L 5 % . 3.3 EPA . AAMI ANSI/ AAMI RD5 EPA , , , , , . “ ” . EPA 28 % “ ” . EPA 1/10 . , . . (1) EPA . (2) 90 % 99 % . (3) . 7 KS

12、P ISO 13959:2009 Keshaviah . EPA . Keshaviah , 0.05 mg/L 2 0.05 mg/L . EPA 0.01 mg/L 2006 1 26 . . , , , . , . EPA 1/10 , . . . . . AAMI . 2 . . , . , 2 . 2 . 2008 . 2 . . , . . 90 % . . 1 2 . . . . 1 ( ) . . 8 KS P ISO 13959:2009 . , . . 17 . 0.02 mg/L 0.08 mg/L . . , , . . , . . . EPA 50 (MCL) . ( ), 10 . ,