KS P ISO 22870-2009 Point-of-care testing(POCT)－Requirements for quality and competence《护理点试验(POCT) 质量和能力要求》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 22870 (POCT) KS P ISO 22870:2009 2009 12 29 http:/www.kats.go.krKS P ISO 22870:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 22870:2009 . . ii 1 1 2 1 3 .1

2、 4 .1 4.1 1 4.2 .2 4.3 3 4.4 3 4.5 .3 4.6 .4 4.7 4 4.8 .4 4.9 .4 4.10 4 4.11 5 4.12 .5 4.13 .5 4.14 5 4.15 .5 5 6 5.1 .6 5.2 .7 5.3 7 5.4 8 5.5 .8 5.6 .8 5.7 9 5.8 .9 10 i KS P ISO 22870:2009 2006 1 ISO 22870, Point-of-care testing(POCT) Requirements for quality and competence . . . , , . , , . ii K

3、S P ISO 22870:2009 (POCT) Point-of-care testing(POCT) Requirements for quality and competence 1 (POCT) KS P ISO 15189 . , POCT . , . . , . 2 . . ( ) . KS P ISO 15189, 3 . 3.1 (point-of-care testing) POCT (near-patient testing) 4 4.1 4.1.1 KS P ISO 15189 4.1.1 . POCT , . KS P ISO 22870:2009 a) POCT b

4、) POCT c) POCT , d) POCT POCT . 4.1.2 KS P ISO 15189 4.1.2 4.1.2.1 4.1.2.5 . 4.1.2.1 ( : ) POCT . , POCT , , . 4.1.2.2 , , POCT POCT . 4.1.2.3 . 4.1.2.4 POCT . POCT , , , . . 4.1.2.5 POCT , . 4.1.3 KS P ISO 15189 4.1.3 . 4.2 4.2.1 KS P ISO 15189 4.2 4.2.2 4.2.5 . 4.2.2 , , . 4.2.2.1 . a) POCT b) c)

5、d) e) , f) g) POCT POCT . , , . 2 KS P ISO 22870:2009 4.2.2.2 POCT , , . 4.2.3 . a) b) c) d) , e) “ ” , , . . , (type) . 4.2.4 KS P ISO 15189 4.2.3 . . a) POCT b) c) (integrity) 4.2.5 KS P ISO 15189 4.2.4 . . a) b) c) 4.3 KS P ISO 15189 4.3, 4.3.1, 4.3.2 4.3.3 . 4.4 KS P ISO 15189 4.4 . 4.5 . 3 KS P

6、 ISO 22870:2009 4.6 KS P ISO 15189 4.6 . 4.7 KS P ISO 15189 4.7 . 4.8 KS P ISO 15189 4.8 . 4.9 4.9.1 KS P ISO 15189 4.9 4.9.2 4.9.4 . 4.9.2 POCT . POCT . POCT . a) b) POCT , c) . 4.9.3 , . . 4.9.4 . a) / / ( 4.12 ) b) POCT (4.2 ) c) POCT d) 4.10 4.10.1 KS P ISO 15189 4.10 4.10.2 4.10.3 . 4.10.2 . .

7、4.10.3 . a) ( / ) 4 KS P ISO 22870:2009 b) c) d) e) f) 4.11 4.11.1 KS P ISO 15189 4.11 4.11.2 4.11.3 . 4.11.2 . . 4.11.3 . a) b) c) d) e) 4.12 4.12.1 KS P ISO 15189 4.12 4.12.2 . 4.12.2 POCT . 4.13 4.13.1 KS P ISO 15189 4.13 4.13.2 . 4.13.2 . , , . , , , , . 4.14 KS P ISO 15189 4.14 . a) POCT . b) P

8、OCT , . 4.15 4.15.1 KS P ISO 15189 4.15 4.15.2 4.15.4 . 5 KS P ISO 22870:2009 4.15.2 . POCT 7 . 4.15.3 . a) b) / / c) d) e) f) g) 4.15.4 , . 5 5.1 KS P ISO 15189 5.1 5.1.1 5.1.5 . 5.1.1 . a) POCT , b) , POCT c) / / 5.1.2 KS P ISO 15189 5.1.3 . . a) POCT , , b) POCT / POCT . 5.1.3 KS P ISO 15189 5.1.

9、4 . 5.1.4 KS P ISO 15189 5.1.7 . POCT . . 6 KS P ISO 22870:2009 5.1.5 KS P ISO 15189 5.1.4 , 5.1.9, 5.1.11, 5.1.12 . . a) POCT , . POCT / . b) POCT . / / . c) / . / , ( ), . d) . e) POCT . 5.2 5.2.1 KS P ISO 15189 5.2 5.2.2 5.2.3 . 5.2.2 POCT / . 5.2.3 POCT . 5.3 5.3.1 KS P ISO 15189 5.3 5.3.2 . 5.3

10、.2 , . a) ID, / , , POCT . b) , . c) POCT . 7 KS P ISO 22870:2009 d) , POCT . e) POCT . f) / . 5.4 5.4.1 KS P ISO 15189 5.4 5.4.2 5.4.3 . 5.4.2 ID . 5.4.3 POCT . . , . 5.5 5.5.1 KS P ISO 15189 5.5 5.5.2 5.5.4 . 5.5.2 POCT . 5.5.3 , , . 5.5.4 . 5.6 5.6.1 KS P ISO 15189 5.6 5.6.2 5.6.8 . 5.6.2 POCT ,

11、. POCT . 5.6.3 POCT / . , POCT . 5.6.4 KS P ISO 15189 5.6.4 . 5.6.5 , (EQA) (KS A ISO/IEC Guide 431 ). , . 5.6.6 POCT / . POCT , . 8 KS P ISO 22870:2009 5.6.7 KS P ISO 15189 5.6.6 . 5.6.8 KS P ISO 15189 5.6.7 . . a) , QC . b) QC POCT . c) QC . d) . e) QC . f) QC . g) . h) , POCT . 5.7 5.7.1 KS P ISO

12、 15189 5.7 . , , . 5.7.2 , . . 5.8 5.8.1 KS P ISO 15189 5.8 5.8.2 5.8.4 . 5.8.2 POCT . 5.8.3 POCT . ID . 5.8.4 POCT . 9 KS P ISO 22870:2009 1 KS A ISO/IEC Guide 431, 1 ： 2 EN 376： 2002, Information supplied by the manufacturer with in vitro diagnostics for self-testing 3 EN 592： 2002, Instructions f

13、or use for in vitro diagnostic instruments for self-testing 4 JANSEN, R.T.P., BLATON, V., BURNETT, D., HUISMAN, W., QUERALTO, J.M., ZRAH, S. and ALLMAN, B., European Communities Confederation of Clinical Chemistry, Essential criteria for quality systems of medical laboratories, European Journal of C

14、linical Chemistry and Clinical Biochemistry, 35, 1997, pp. 123-132 5 JANSEN, R.T.P., BLATON, V., BURNETT, D., HUISMAN, W., QUERALTO, J.M., ZRAH, S. and ALLMAN, B., European Communities Confederation of Clinical Chemistry, Additional essential criteria for quality systems of medical laboratories, Cli

15、nical Chemistry and Laboratory Medicine, 36, 1998, pp. 249-252 6 JACOBS, E. In : Kaplan and Pesce, eds. POCT In Clinical Chemistry : Theory, Analysis, and Correlation. 4th ed. St. Louis : Mosby 2003 7 PRICE, C.P., ST. JOHN, A. and HICKS, J.M. Point-of-Care Testing. 2nd ed. Washington DC : AACC Press

16、; 2004 8 MDA DB2002(03). Management and Use of IVD Point of Care Test Devices. Medical Devices Agency;UK : 2002 9 MDA DB2002(02). Management of in vitro Diagnostic Medical Devices. Medical Devices Agency ; UK, 2002 10 BURNETT, D. Accreditation and point-of care testing. Ann Clin Biochem. 37, 2000, p

17、p. 241-243 11 FREEDMAN, D.B. Clinical governance: Implications for point-of-care testing. Ann Clin Biochem. 39, 2002, pp. 421-423 12 POCT Guidelines v. 1.0. Jpn J Clin Lab Automation. 29, Suppl 3, 2004 10 (POCT) 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 22870:2009 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Point-of-care testing(POCT) Requirements for quality and competence ICS 03.120.10 ; 11.100.01 Korean Agency for Technology and Standards http:/www.kats.go.kr