KS P ISO 6710-2009 Single-use containers for venous blood specimen collection《静脉取血样用一次性容器》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 6710 KS P ISO 6710 :2009 2009 12 7 http:/www.kats.go.krKS P ISO 6710:2009 : ( ) ( ) () () ( ) : (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 6710:2009 i .1 1 1 2 1 3 .1

2、 4 3 5 3 6 3 7 4 8 4 9 4 10 4 11 .5 A() 7 B() .8 C() 10 D() 12 E() .13 F() .15 KS P ISO 6710:2009 Single-use containers for venous blood specimen collection 1995 1 ISO 6710, Single-use containers for venous blood specimen collection , . A, B, C, D E , F . 1 . . ISO 4822, 25 mL . 2 . . ( ) . KS M ISO

3、 3696, KS S ISO 7000, ISO 5941：1986, Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipmentPart 1：General requirements 3 . 3.1 (container) 3.2 (evacuated container) , (, - ) . KS P ISO 6710:2009 2 3.3 (tube) , 3.4 (closure) 3.5 (primary pack) 3.6 (container

4、 interior) 3.7 (additive) ( .) 3.8 (nominal capacity) 3.9 (free space) A B . 3.10 (fill line) 3.11 (draw volume) 3.12 (expiry date) 3.13 (closing torque) , , . 3.14 (visual inspection) 300 lx 750 lx - KS P ISO 6710:2009 3 4 4.1 . ( 1 ). 4.2 , (10.4 ). , . ( ) , . . 4.3 . (validation) . , . 4.4 . 5 5

5、.1 A B , 10 % . 5.2 , A B . 1 . . 1 0.5 mL 5 mL 5 mL 25 % 15 % 6 6.1 C , . KS P ISO 6710:2009 4 6.2 , . (blood cell counters) . 6.3 C , . 7 7.1 D 3 000 g . g n 9.806 65 m/s 27.2 , , . 8 8.1 , . . , . . , . 8.2 . 9 9.1 E . (9.2 ), . , . E . EDTA , . 9.2 . 10 KS P ISO 6710:2009 5 10.1 . 10.2 (41) 48 .

6、 . (： ), . . 10.3 . a) b) c) d) (： ) / 2 , “ (sterile)” “ (single-use only)” KS S ISO 70001051 10.4 , . 10.5 . a) b) c) (11. ) / d) e) f) , g) , “ ” . 11 2 / . 2 , . 1 . 2 2 . 3 . KS P ISO 6710:2009 6 2 EDTA a K2E K3E N2E 9 ：1 b9NC 4 ：1 b4NC / /EDTA / FX FE FH LH NH CPDA c . Z a EDTA ( ) . b (, 9 1)

7、. c - Z . KS P ISO 6710:2009 7 A () A.1 A.1.1 KS M ISO 3696 20 25 A.1.2 , 0.1 mL (0.1 mL ) 50 mL A.2 A.2.1 20 , 101 kPa , . A.2.2 . A.3 A.3.1 . A.3.2 . . A.3.3 . A.3.4 . 0.1 mL . A.4 A.4.1 10 % . A.4.2 , 1 . , - . . , . KS P ISO 6710:2009 8 B () B.1 B.1.1 KS M ISO 3696 20 25 B.1.2 , 0.1 mL (0.1 mL )

8、 50 mL B.1.3 , ( ) B.1.4 B.1.5 B.2 B.2.1 B.2.1.1 20 , 101 kPa , . B.2.1.2 . B.2.2 B.2.2.1 , . . B.2.2.2 , . . B.2.2.3 / . B.2.2.4 / . B.2.2.5 1 . B.2.2.6 0.1 mL . B.2.3 KS P ISO 6710:2009 9 10 % . B.3 B.3.1 B.3.1.1 20 , 101 kPa , . B.3.1.2 . B.3.2 B.3.2.1 , . B.3.2.2 . B.3.2.3 . B.3.2.4 0.1 mL . (B.

9、2 ) . B.3.3 1 , . , - . . , . KS P ISO 6710:2009 10 C () C.1 C.1.1 60 g/L 70CAS 9004540 0.15 mol/L NaCl：CAS 7647145 100 mL uranine：CAS 518478 1)2.5 g . C.1.2 - (C.2.2) . C.2 C.2.1 (1 m .) ( ). , . , ISO 5941 6 %(Luer) . C.2.2 (UV) C.2.3 C.2.4 ( ) C.3 C.3.1 (C.1.1) . C.3.2 , . . . (push-in) . (snap-o

10、n) . C.3.3 - . UV . C.3.4 2 . 100 mL . 15 20 60 . , C.3.3 UV . 1) CAS Chemical Abstracts Service . KS P ISO 6710:2009 11 C.4 C.4.1 (C.1.1) . C.4.2 , . , C.3.3 UV . C.4.3 C.3.4 . C.5 C.5.1 (C.1.1) . C.5.2 . a) , . C.3.3 UV . b) C.3.2 C.3.3 . C.5.3 C.3.4 . C.6 . KS P ISO 6710:2009 12 D () D.1 D.1.1 D.

11、1.2 D.1.3 3 000 g 10 D.2 D.2.1 . . D.2.2 . D.2.3 3 000 g 10 . . D.3 . KS P ISO 6710:2009 13 E () E.1 (EDTA)CH 2 N(CH 2 COOH) 2 2 ：CAS 60004 CAS 25102129, CAS 17572973, CAS 6381926 1 mL EDTA 1.2 mg2 mg EDTA sequestric acid (0.004 11 mol/L0.006 843 mol/L) . . E.2 Na 3 C 6 H 5 O 7 2H 2 O：CAS 6132043 E.

12、2.1 0.1 mol/L0.136 mol/L . 10 %. E.2.2 ： 1 9 ( 1 ). E.2.3 ： 1 4 ( 2 ). E.3 / 1 mL CAS 6487485 1 mg3 mg(0.003 934 mol/L 0.001 1 mol/L), CAS 7681494 2 mg4 mg(0.047 6 mol/L0.095 2 mol/L) . E.4 /EDTA 1 mL EDTA 1.2 mg2 mg, 2 mg4 mg . E.5 / 1 mL 1230, 2 mg4 mg . E.6 /CAS 9041081 /CAS 9045221 1 mL 1230 . E

13、.7 (CPDA) E.7.1 ( 3 ). () 2.99 g CAS 77929 KS P ISO 6710:2009 14 () 26.3 g CAS 6132043 1 () 2.22 g NaH 2 PO 4 H 2 O：CAS 10049215 () 31.9 g CAS 5996101 0.275 g C 5 H 5 N 5 ：CAS 73245 1 000 mL . E.7.2 CPDA 1 6 . E.7.3 10 %. . EDTA , . KS P ISO 6710:2009 15 F () 1 Recommended methodology for using WHO

14、International Reference Preparations for Thromboplastin, 1983, World Health Organization, Geneva, Switzerland 2 International Committee for Standardization in Haematology, 1977, Recommendation for measurement of erythrocyte sedimentation rate of human blood, American Journal of Clinical Pathology, 6

15、8 4, 1977, pp. 505507 3 Anticoagulant Citrate Phosphate Dextrose Adenine Solution, pp. 101102, The United States Pharmacopoeia, The National Formulary, USP XXII, NF XVII, 1990, United States Pharmacopoeial Convention, Inc., Rockville, MD, USA 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 6710 :2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Single-use containers for venous blood specimen collection ICS 11.040.20 Korean Agency for Technology and Standards http:/www.kats.go.kr