KS P ISO 17593-2009 Clinical laboratory testing and in vitro medical devices-Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy 《临床实验室测试和.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 17593 KS P ISO 17593:2009 2009 12 29 http:/www.kats.go.krKS P ISO 17593:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 17593:2009 . iii 1 1 2 1 3 .2 4 .7 4.

2、1 7 4.2 .8 4.3 .8 4.4 .8 4.5 8 4.6 9 4.7 .10 5 11 5.1 11 5.2 11 5.3 .11 5.4 13 5.5 .13 6 .14 6.1 14 6.2 .14 6.3 14 6.4 15 6.5 15 6.6 15 6.7 , .15 6.8 15 6.9 .15 6.10 , 16 6.11 .16 6.12 16 6.13 17 7 .17 7.1 17 7.2 17 i KS P ISO 17593:2009 8 18 8.1 .18 8.2 .18 8.3 .19 8.4 .19 8.5 .23 8.6 31 9 32 9.1 .

3、32 9.2 .32 9.3 .32 9.4 33 9.5 .33 9.6 34 9.7 .34 A () .35 A.1 .35 A.2 .35 A.3 .35 A.4 35 B () 37 C ( ) ( 42) .40 D ( ) INR .41 E () .44 F ( ) .45 50 ii KS P ISO 17593:2009 2007 1 ISO 17593, Clinical laboratory testing and in vitro medical devicesRequirements for in vitro monitoring systems for self-

4、testing of oral anticoagulant therapy . . . , , . , , . iii KS P ISO 17593:2009 Clinical laboratory testing and in vitro medical devicesRequirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy 1 K , , . K ( INR .) . (： ) . K . . . 2 . . ( ) . KS C IEC 61010 1, , 1：

5、 KS C IEC 61000 42, (EMC) KS C IEC 610004 3, (EMC) 4 3 ： KS P ISO 13485, KS P ISO 15198, KS P ISO 17511, KS P ISO 17593:2009 ISO 14971： 2000, Medical devicesApplication of risk management to medical devices ISO 18113 1： 1), Clinical laboratory testing and in vitro diagnostic medical systems Informat

6、ion supplied by the manufacturer(labelling)Part 1 ：Terms, definitions and general requirements ISO 18113 4： 1), Clinical laboratory testing and in vitro diagnostic medical systemsInformation supplied by the manufacturer(labelling)Part 4 ：In vitro diagnostic reagents for self-testing ISO 18113 5： 1),

7、 Clinical laboratory testing and in vitro diagnostic medical systemsInformation supplied by the manufacturer(labelling)Part 5 ：In vitro diagnostic instruments for self-testing IEC 60068 264 ：1993, Environmental testing Part 2 ：Test methods Test Fh : Vibration, broad-band random(digital control) and

8、guidance IEC 61010 2101 ：2002, Safety requirements for electrical equipment for measurement, control and laboratory usePart 2 101：Particular requirements for in vitro diagnostic(IVD) medical equipment IEC 61326, Electrical equipment for measurement, control and laboratory useEMC requirements EN 1353

9、2：2002, General requirements for in vitro diagnostic medical devices for self-testing EN 13612, Performance evaluation of in vitro diagnostic medical devices EN 13640, Stability testing of in vitro diagnostic reagents WHO Technical Report Series, No. 889, 1999, Annex 3Guidelines for thromboplastins

10、and plasma used to control oral-anticoagulant therapy 3 ISO 18113 1 . 3.1 1 “ ” (bias) (VIM ： 1993). 2 , IRP(International Reference Preparation) INR . 3 KS Q ISO 35341 3.11 3.2 KS A ISO 57251 3.8 VIM ：1993. 3.3 , . . 1) 2 KS P ISO 17593:2009 3.4 . . 3.5 , 1 EN 375： 2001 3.5 2 . . : ( ) . 3.6 3.7 ,

11、, , . 3.8 . . 3.9 INR INR Poller 30 . 3.10 IRP (WHO) IRP INR . 3 KS P ISO 17593:2009 3.11 1 KS A ISO 5725 35 . 2 . 3 . 3.12 , , , / 3.13 ISI ISI INR Poller 30 . 3.14 1 EN 376： 2002 “ ” 2 , . 3.15 1 KS P ISO 17511： 2005 2 PT . 3 (assigned) IRP . 3.16 KS P ISO 17511 4.2.2 f) . 3.17 4 KS P ISO 17593:20

12、09 KS P ISO 17511 4.2.2 h) . 3.18 VIM :1993 2.5 3.19 1 . 2 VIM :1993 5.4 3.20 , , VIM :1993 6.10 3.21 1 . 2 . 3.22 1 KS Q ISO 35342 2 . . 3 . “ ( 3.26)” “ (3.28)” . 3.23 PT 3.24 . 5 KS P ISO 17593:2009 3.25 3.26 KS Q ISO 35342 3.27 1 KS Q ISO 35342 2 3 “ ” “ ” . 3.28 KS Q ISO 35342 3.29 1 2 “ ” “ ”

13、. 3 KS Q ISO 35342 3.30 “ ” . 3.31 1 “ ” . 2 . 3 95 % 6 KS P ISO 17593:2009 . . 4 KS P ISO 15197 3.24 3.32 1 ( 3.2) . 2 KS Q ISO 35342 3.33 ( ) . 1 . 2 IEC 61326： 2002 3.34 3.35 , . . 3.36 1 SI () . 2 “ (haematocrit)” . 4 4.1 KS P ISO 13485 . EN 13532 . 6. 8. , , 7 KS P ISO 17593:2009 . 9. . 4.2 1.0

14、 6.0 INR . 4.3 KS C IEC 61010 1 IEC 61010 2 101 . 4.4 4.4.1 . a) b) c) ( : ) d) , e) CLSI EP725 . 4.4.2 ISO 14971 . . a) ( : ) b) ( : ) c) ( : ) 1 . 2 “” CLSI EP1827 . 3 , , . 4.5 . a) : 8 KS P ISO 17593:2009 b) : c) : d) : “ ” ( : “ ” “ ” “ ”) 4.6 4.6.1 . E . . ISO 14971 . . (7. ) / . 4.6.2 . . . 4

15、.6.3 . . KS P ISO 15198 . , . ( : ), . 9 KS P ISO 17593:2009 . , . . . 4.6.4 . . 6 . , ( : ). 4.6.5 . 4.7 KS P ISO 17511 . / IRP WHO ( 44) . 1 WHO , . , . , WHO IRP . . , WHO IRP . ( : ). . 2 B.1 . KS P ISO 17511 5 , . 10 KS P ISO 17593:2009 , . 3 (Cpk) . 40 . . KS P ISO 15193 KS P ISO 15194 . . . 5 5.1 . . . . . . . . , . 5.2 . a) b) ( .) c) d) e) f) , . . . 5.3 ISO 18113 5 . 11 KS P ISO 17593:2009