KS P ISO TR 18112-2009 Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements 临床.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO TR 18112 KS P ISO TR 18112:2009 2009 12 29 http:/www.kats.go.krKS P ISO TR 18112:2009 : ( ) ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2009 12 29 2009-0931 ： ： (ISO/TC 194) ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO TR 18112:2009 i

2、 .1 1 1 2 1 3 .2 4 .2 4.1 2 4.2 .2 4.3 3 4.4 3 4.5 , , , , .4 4.6 4 4.7 4 4.8 4 4.9 .5 4.10 5 4.11 5 4.12 ( ) 5 4.13 ( : , , ) .5 4.14 6 4.15 .6 4.16 6 4.17 6 4.18 (metrological traceability)7 4.19 7 4.20 ( )7 4.21 7 4.22 .8 4.23 8 4.24 8 4.25 .9 A( ) 10 118 KS P ISO TR 18112:2009 Clinical laborator

3、y testing and in vitro diagnostic test systems In vitro diagnostic medical devices for professional use Summary of regulatory requirements for information supplied by the manufacturer 2006 1 ISO/TR 18112, Clinical laboratory testing and in vitro diagnostic test systems In vitro diagnostic medical de

4、vices for professional use Summary of regulatory requirements for information supplied by the manufacturer . 1 IVD . . , EU, . GHTF(Global Harmonization Task Force) . IVD . 2 EN 375： 2001 EN 591： 2001 . TC 212 , . A , . KS P ISO TR 18112:2009 2 EN 375 EN 591 , . , . , . CEN ( , , , ). (Type) . , . 3

5、 . ( : , , ) ( , .) , . 4 . 4.1 GHTF . EU, IVD . , IVD . EU , IVD . 4.2 GHTF . , EU, / GHTF KS P ISO TR 18112:2009 3 . (Canadian Food and Drugs Act) “ , , , , ” , GHTF “ (labelling)” EU “ ” . 4.3 , . GHTF , ( : , ). , “ (accompany)” . (U.S. Federal Food, Drug and Cosmetic Act) “ (accompany)” , (inte

6、rstate commerce) , , , , , , , , (filler) . (Canadian Medical Devices Regulations) . IVD . EU IVD (IVD Medical Device Directive) . “ ” . . 4.4 GHTF , , , . . , IVD . . IVD KS P ISO TR 18112:2009 4 . . EN ( : ) . , IVD . 4.5 , , , , , . EU IVD . EU “ ” . . . ( : / ). 4.6 . EU IVD . 4.7 GHTF . . . EU

7、, . . . , . 4.8 GHTF , . KS P ISO TR 18112:2009 5 , EU IVD GHTF . . FDA KS P ISO 15223 EN 980 25 . 4.9 IVD KS X ISO 8601 ( , CCYY-MM-DD) . . . 4.10 . , . . EU . . 4.11 . . (US Food Drug and Cosmetic Act) . CE . 4.12 ( ) . , . “ (in vitro diagnostic use)” EU “ (in vitro use)” . (FDA) IVD . 4.13 ( : ,

8、 , ) . , EU , KS P ISO TR 18112:2009 6 . IVD . IVD (Federal Hazardous Substances Control Act) , . , , EU ( ) . / . . / . . 4.14 . . 4.15 . . . 4.16 EU , SI (KS A ISO 1000) . SI . IVD , , . , . 4.17 . , , (trueness), . . . : (CLIA 88) EU IVD . (1) , (2) KS P ISO TR 18112:2009 7 “ (trueness)” , “ (acc

9、uracy)” . . : ( ), ( ) ( ) . . “ (within-run),” “ (within lab)” “ (lab to lab)” . VIM :1993 KS Q ISO 3534 KS A ISO 5725 . VIM CEN . : IVD . . 4.18 (metrological traceability) EU , . . FDA FDA , ( , ) . . 4.19 GHTF . EU . FDA “ (true)” . . 4.20 ( ) . , EU / . 4.21 KS P ISO TR 18112:2009 8 GHTF , 5 EN

10、 . EN “ (if known)” . . EU SI , . 4.22 , , EU . EU “ ” . EU “ ” . , (“ ” .) . . GHTF . 4.23 . ( : KS P ISO 13485) / . 4.24 . . GHTF “ ” . EU “ ” . “ ” . (Health Canada) . . “ ” , / . KS P ISO TR 18112:2009 9 4.25 EN 591 . . , EU . , EU GHTF . , EU . , EU, GHTF IVD . IVD , . . CEN . CEN . , EU GHTF .

11、 KS P ISO TR 18112:2009 10 A ( ) CEN EU 2003a GHTF 1 EN 375 : 2001, 10 bEN 591 : 2001, 11 , NCCTG (National Coordinating Committee for Therapeutic Goods) IDDWG(In vitro Diagnostic Device Working Group), 2003 3 1 (Canadian Medical Devices Regulations), (Food and Drugs Act), 1998 5 5 (Health Canada) (

12、Health Products and Food Branch), , 2003 1 22 4 1998 10 27 98/79/EC (European Parliament and the Council) 98/79/ EC(Directive 98/79/ EC) 8 (Pharmaceutical Affairs Law) ( 2003) 24 (U.S. Federal Food, drug, and Cosmetic Act) 36, 37 (U.S. Code of Federal Regulations), 21 27-33 FDA FDA 39-43 ( ), 2002 3 1( )16 2 3 . a) , , ( IVD .) 10, 1 , , , , , IVD .a) b) . . . IVD IVD . , , , . 31, Sec. 809.10 , , , “ ” KS P ISO TR 18112:2009 11 CEN EU 2003a GHTF b) , ( IVD .) . . 11, 1 . . 7, Article 1, 1 GHTF . 13 4 5 KS A ISO 1000, SI 10, 2; 11, 2 . 6 7 . IVD ( : ) Directive 93/ 42/EEC “ ”