KS P ISO 1135-3-2009 Transfusion equipment for medical use－Part 3：Blood-taking set《医用输液设备 第3部分 取血器具》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11353 3：- KS P ISO 11353 :2009 2009 12 7 http:/www.kats.go.krKS P ISO 11353:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ： 2004 12 18 ： 2009 12 7 2009-0762 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 11353:2009 i .1 1 1

2、2 1 3 1 3.1 .1 3.2 - .2 3.3 - .3 3.4 .3 3.5 .3 3.6 3 4 3 5 .3 5.1 .3 5.2 3 5.3 .4 5.4 - 4 5.5 - 4 5.6 .4 5.7 4 6 .4 6.1 () 4 6.2 4 6.3 5 6.4 5 6.5 .5 7 .5 7.1 (type) .5 7.2 .5 8 6 8.1 6 8.2 (multi-unit) .6 8.3 .6 9 6 A() .7 KS P ISO 11353:2009 ii B() .8 B.1 8 B.2 () .8 B.3 .8 B.4 .8 B.5 9 B.6 9 C()

3、.10 C.1 10 C.2 (type) 10 C.3 10 KS P ISO 11353:2009 3：- Transfusion equipment for medical usePart 3：Blood-taking set 1986 1 ISO 11353, Transfusion equipment for medical usePart 3： Blood-taking set , . 1 - (types) . (type) , ( ). . . a) b) . - . 2 . . ( ) . KS L ISO 1773, KS M ISO 3696, ISO 7864, Ste

4、rile hypodermic needles for single use 3 3.1 KS P ISO 11353:2009 2 - - - , . - 1 . a) - b) - (cap) - 1) - - , - . 1 - 3.2 - 1) . KS P ISO 11353:2009 3 - (- ) ( ) . . 3.3 - - (- ) . . 3.4 . . 3.5 (cap) . 3.6 3.6.1 - (S) - (TK) . - KS P ISO 11353TKS 3.6.2 - (C) - (TK) . - KS P ISO 11353TKC 4 - . . (ty

5、pe) C . 5 5.1 - A . 5.2 20 N 15 . KS P ISO 11353:2009 4 5.3 5.3.1 35 mm . 1.8 mm , 70 % . 5.3.2 . 5.3.3 90 N 15 . 5.3.4 ISO 7864 . 5.4 - - 0.7 mm , 1.9 mm . 25 mm . 5.5 - 5.5.1 - 35 mm . 2 mm , 70 % . 5.5.2 . , . 5.5.3 15 20 N . 5.6 2.7 mm . 600 mm . . 5.7 5.7.1 . 5.7.2 . . 6 6.1 () B.2 c(KMnO 4 )0.

6、002 mol/L 2.0 mL . 6.2 (AAS) , 1 g/mL(1 ppm) KS P ISO 11353:2009 5 , , , 0.1 g/mL(0.1 ppm) . B.3 , (Pb 2 )1 g/mL . 6.3 B.4 1 mL . 6.4 B.5 5 mg . 6.5 B.6 S 1 0.1 (optical density). 7 - , , , . 7.1 (type) . . a) C.2 , . , . . b) - , . c) . d) 7.2 7.2.1 - ( C .), - . 7.2.2 - ( KS P ISO 11353:2009 6 C .

7、), - . 8 8.1 - . a) / b) - c) (cap) - d) , , e) () f) / g) - h) , 8.2 (multi-unit) (multi-unit) . a) / b) - c) (unit) d) “STERILE” a) . e) f) () g) , h) , 8.3 . a) b) / c) - d) () e) , f) , 9 9.1 - , . 9.2 - . KS P ISO 11353:2009 7 A () - 20 kPa(200 mbar) , 20 30 15 , . KS P ISO 11353:2009 8 B () B.

8、1 . 300 mL . (371) . 2)250 mL 1 L/h 2 ( , ). . S 1 . 250 mL - , S 0 . S 1 S 0 . B.2 () B.1 S 110 mL c(KMnO 4 )0.002 mol/L 10 mL c(H 2 SO 4 )1 mol/L 1 mL , 15 . 0.1 g , c(Na 2 S 2 O 3 )0.005 mol/L . 5 . . 0.002 mol/L (：mL) . B.3 B.1 S 110 mL . S 1 . B.4 S 120 mL Tashiro 0.1 mL . c(NaOH)0.01 mol/L, c(

9、HCL)0.01 mol/L . 2) . KS M ISO 3696 1 2 . KS P ISO 11353:2009 9 mL . B.5 S 150 mL , , . 105 . S 050 mL . S 1 S 0 (mg) . B.6 S 1 ( 0.45 m) . 5 1 cm S 0 UV 250 nm 320 nm . () . KS P ISO 11353:2009 10 C () C.1 (NaCl)9 g/L 50 mL 10 mL/min . - 30 . C.2 (type) C.1 . C.1 , C.2.1 ASTM F 813, C.2.2 () BS 573

10、6：2, C.2.3 (hemolysis) C.2.4 ( ) BS 5736：3, ： C.2.5 (sensitization) ASTM F 748, BS 5736：6, . C.2.6 () BS 5736：4, C.2.7 BS 5736：5, ： C.2.8 C.3 C.3.1 KS P ISO 11353:2009 11 . , C.1 C.2.8 . C.3.2 . , C.1 C.2.7 . 3：- 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 11353 :2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Transfusion equipment for medical use Part 3 ：Blood-taking set ICS 11.040.20 Korean Agency for Technology and Standards http:/www.kats.go.kr