1、 KSKSKSKSKS P ISO 13958KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 13958:2009 2009 12 25 http:/www.kats.go.krKS P ISO 13958:2009 : ( ) ( ) ( ) () ( ) : (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 13958:2009 .1 1 1 1.1 .1 1
2、.2 .1 1.3 1 2 1 3 .2 4 (Requirements)5 4.1 (Concentrates) .5 4.2 (Manufacturing equipment) 7 4.3 (Systems for mixing concentrate at a dialysis facility).7 5 (Tests) 9 5.1 (General) 9 5.2 (Concentrates) .9 5.3 (Manufacturing equipment) 11 5.4 (Systems for mixing concentrate at a dialysis facility) 11
3、 6 (Labelling) .12 6.1 (General) 12 6.2 (General labelling requirements for concentrates) 13 6.3 (Labelling requirements for liquid concentrate) 13 6.4 (Labelling requirements for powder concentrate).14 6.5 (Additives)14 6.6 (Labelling requirements for concentrate generators)14 6.7 (Labelling for co
4、ncentrate mixer systems) .15 A( ) .17 A.1 (Scope).17 A.2 (Requirements) 17 A.3 (Labelling) 21 22 i KS P ISO 13958:2009 Concentrates for haemodialysis and related therapies 2009 2 ISO 13958, Concentrates for haemodialysis and related therapies . 1 1.1 . “ ” , . , . . 1.2 ( ) . . 1.3 . . . ISO 23500 .
5、 . 2 . . ( ) . KS P ISO 13958:2009 KS C IEC 60601 1, KS C IEC 61010 1, , 1： KS P ISO 13959, ISO 11663, Quality of dialysis fluid for haemodialysis and related therapies 3 . 3.1 (acetate dialysing fluid) 1 . 2 3 . 3.2 (acid concentrate) A (A concentrate) 1 “” ( ) . 2 . 3 . 3.3 (additive) (spike) 3.4
6、(batch system) , 3.5 (bicarbonate concentrate) B (B concentrate) 1 . 2 . 3 . 4 . 2 KS P ISO 13958:2009 3.6 (bicarbonate dialysing fluid) . ( 3.2 3.5 ). 3.7 (bulk delivery) . . . 3.8 (bulk storage tank) , 3.9 (central concentrate system) 3.10 (concentrate generator) . 3.11 (concentrate mixer) 3.12 (d
7、ialysing fluid) ( ) 1 “ (dialysing fluid)” , . 2 “ (fresh dialysing fluid)” “ (spent dialysing fluid)” . 3 . 3 KS P ISO 13958:2009 3.13 (dialysis fluid delivery system) : (1) , ; (2) ; (3) , ( ), , ; (4) 1 , , , , . 2 . 3 . 3.14 (dialysis water) KS P ISO 13959 , 3.15 (endotoxin) A . , , , , . 3.16 (
8、endotoxin units) EU LAL( Limulus amoebocyte lysate) 1 . 2 (IU) . 1983 , EU IU . 3.17 (haemodialysis) 1 . . 3.18 LAL (Limulus amebocyte lysate test) LAL test (Limulus polyphemus) . 4 KS P ISO 13958:2009 3.19 (manufacturer) , , , , , , , , . . 3.20 (proportioning system) 3.21 (user) “” . 4 (Requiremen
9、ts) 4.1 (Concentrates) 4.1.1 (Physical state) . ( ) . 4.1.2 (Solute concentrations) 4.1.2.1 (Liquid solute concentrations) 5 % 0.1 mEq/L( ) . . 2.5 % . 5 % 0.05 g/L ( ) . 5 % . , , , , , . . . , 5 % . 4.1.2.2 (Solute concentrations from powder) 5 KS P ISO 13958:2009 4.1.2.1 . 4.1.3 (Water) KS P ISO
10、13959 . 4.1.4 (Bacteriology of concentrates) 4.1.4.1 (Bacteriology of bicarbonate concentrates) , ISO 11663 . , ISO 11663 . 4.1.4.2 (Bacteriology of acid concentrates) . 4.1.5 (Endotoxin level) ISO 11663 . 4.1.6 (Fill volume) 2 % . , 100 % . 4.1.7 (Chemical grade) . , , , , / pH . . 4.1.8 (Particula
11、tes) 1 m . . 4.1.9 “ ”(Additives “spikes”) 6 KS P ISO 13958:2009 5 % . 4.1.10 (Containers) , , , , . . . ( 2 ) . 4.1.11 (Bulk delivered concentrate) . , . 4.1.12 (Concentrate generators) . . . . . . 4.2 (Manufacturing equipment) (： , ) , , , . 4.3 (Systems for mixing concentrate at a dialysis facili
12、ty) 4.3.1 (General) . 4.3.2 (Materials compatibility) / ( ) . (： ) . , , , . 7 KS P ISO 13958:2009 4.3.3 (Disinfection protection) 4.3.3.1 (General) 6.7.2 k) , . 3 mg/L , 0.1 mg/L , 0.1 mg/L . , . . . 4.3.3.2 (System lock out) , . 4.3.4 (Safety requirements) / . a) . b) . 4.3.5 (Bulk storage tanks)
13、. 0.45 m . . . . . . . 4.3.6 (Ultraviolet irradiators) . 8 KS P ISO 13958:2009 a) 254 nm . b) 16 milliwatt-sec/cm2 , 30 milliwatt-sec/cm2 . c) . d) . e) . 4.3.7 (Piping systems) . . . 4.3.8 (Electrical safety requirements) , KS C IEC 60601 1 . KS C IEC 60601 1 . 5 (Tests) 5.1 (General) 5. 4. . 4. .
14、. . 5.2 (Concentrates) 5.2.1 (Physical state) 4.1.1 . 5.2.2 (Solute concentrations) 5.2.2.1 (Liquid solute concentrations) , , 4.1.2.1 , , , . . pH . 4.1.2.1 . KS P ISO 13959 . 9 KS P ISO 13958:2009 1 . 1 , , , EDTA , ( ), ( ) , , ( ), ( ) , ( ), ( ) ( ), , ( ), 5.2.2.2 (Solute concentrations from powder) 5.2.2.1 . 5.2.3 (Water) 4.1.3 KS P ISO 13959 . 5.2.4 (Bacteriology of bicarbonate concentrates) 4.1.4 . ( )
