KS P ISO 18113-1-2012 In vitro diagnostic medical devices－Information supplied by the manufacturer(labelling)－Part 1：Terms definitions and general requirements.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 18113 1 ( ) 1： KS P ISO 18113 1:2012 2012 9 17 http:/www.kats.go.krKS P ISO 18113 1:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2012 9 17 2012-0423 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 18113 1:2012 i ii . iii 1 1 2

2、1 3 .1 4 .17 4.1 .17 4.2 .18 4.3 .18 4.4 18 4.5 .18 4.6 19 4.7 19 4.8 .20 4.9 20 4.10 .20 A( ) 21 A.1 .21 A.2 22 A.3 27 44 KS P ISO 18113 1:2012 ii KS P ISO 18113 “ ( )” . 1： 2： 3： 4： 5： . . , , . , , . KS P ISO 18113 1:2012 iii 2009 1 ISO 18113 1, In vitro diagnostic medical devices Information sup

3、plied by the manufacturer(labelling) Part 1： Terms, definitions and general requirements . KS P ISO 18113 1:2012 ( ) 1： In vitro diagnostic medical devices Information supplied by the manufacturer(labelling) Part 1： Terms, definitions and general requirements 1 , , . , . . a) ( , ) b) c) 2 . . ( ) .

4、 KS A ISO 80000 1, 1： KS P ISO 13485, ISO 14971, Medical devices Application of risk management to medical devices ISO 15223 1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1： General requirements IEC 62366, Medical devices Application

5、of usability engineering to medical devices EN 980, Symbols for use in the labelling of medical devices 3 KS P ISO 18113 2 5 . . , 4.6.2 . , . KS P ISO 18113 1:2012 2 KS . , . , . “ ” . , , , . , , , , , , , , , . A . 3.1 (accessory) . . 37, 5.0, 3 . 3.2 (advisory notice) / . KS P ISO 13485, 3.3 3.3

6、 (analyte) “24 ” “ ” “ ” . “ ” “ ” “ ” . , “ (3.39)” . KS P ISO 17511, 3.2 . 3.4 (authorized representative) KS P ISO 18113 1:2012 3 , 1 (EU) 98/79/EC 38 (EC) EC “EC ” . 2 39 . 3.5 (batch) (lot) , 1 , . 2 EN 375, 3.2 . 3.6 (batch code) (lot number) , , / EN 375, 3.3, 40, 820.3(c) 41, I . 3.7 (biolog

7、ical reference interval) (reference interval) 135 mmol/L 145 mmol/L . 1 95 % . . 2 . 3 ( “x”), “x” . 4 “ ”, “ ” “ ” . 5 42, 43, 44 45 . 3.8 (biological reference population) (reference population) 1 , . 2 . , , . KS P ISO 18113 1:2012 4 3 42, 43, 44 45 . 3.9 (calibration) , 1 . 2 (3.10) . ISO/IEC Gu

8、ide 99, 2.39 3.10 (calibration verification) 1 . 2 (3.9), . 3.11 (calibrator) ISO/IEC Guide 99, 5.12 . 3.12 (component) , , , , , , 1 , , / . 2 40, 820.3(c) . 3.13 (control material) , , EN 375, 3.5 3.14 (control procedure) , 1 KS P ISO 18113 1:2012 5 . 2 KS P ISO 15198, 3.5 . 3.15 (distributor) , ,

9、 / 46, 803.3(g) . 3.16 (examination) 1 ( , ) , . 2 , . 3 . KS P ISO 15189, 3.4 3.17 (expiry date) 1 (3.68 ), , , . 2 EN 13640 . 3 EN 375, 3.6 . 3.18 (graphical symbol) KS C IEC 80416 1, 3.1 3.19 (harm) KS A ISO/IEC Guide 51, 3.3 3.20 (harzard) KS A ISO/IEC Guide 51, 3.5 3.21 (hazardous situation) ,

10、KS P ISO 18113 1:2012 6 KS A ISO/IEC Guide 51, 3.6 . ISO 14971, H 3.22 (hazardous waste) , , , , 1 , , , , , , . 2 KS P ISO 15190, 3.13 . 3.23 (healthcare provider) , , , , , , , , 41 . 3.24 (immediate container) (primary container) (vial), , , . EN 375, 3.7 3.25 (importer) 1 , ( , ) . 2 46, 803.3(m

11、) . 3.26 (in vitro diagnostic instrument) IVD (IVD instrument) EN 591, 3.5 . KS P ISO 18113 1:2012 7 3.27 (in vitro diagnostic medical device) IVD (IVD medical device) , , , , , , . 47 . 3.28 (in vitro diagnostic reagent) IVD (IVD reagent) , , EN 375, 3.9 . 3.29 (information supplied by the manufact

12、urer) (labelling) , . . , 1 , IEC “ ” . 2 . 3 KS P ISO 13485, 3.6 . 3.30 (instructions for use) 1 , , . 2 EN 376, 3.9 EN 591, 3.3 . 3.31 (intended use) (intended purpose) , , 1 .： ( , KS P ISO 18113 1:2012 8 “x” ) 2 36 . 3.32 (kit) 1 ( , , ) , , . 2 EN 375, 3.10 . 3.33 (label) , 1 (3.37) . 2 EN 375,

13、 3.12 . 3.34 (lay person) EN 376, 3.13 . 3.35 (limitation of the procedure) 1 . 2 48 . 3.36 (manufacturer) 3 , , , , , 1 . 2 , , , , . 3 “ ” GHTF . ISO 14971, 2.8 3.37 (marking) (writing) KS P ISO 18113 1:2012 9 1 (3.26) . 2 IEC 61010 2-101, 3.106 . 3.38 (material safety data sheet) MSDS 1 , , , , .

14、 2 MSDS . 3 49, 1910.1200 (c) 1910.1200 (g) . 3.39 (measurand) 1 ( , ), ( , ) ( , ) . 2 . 3 3.3 . 4 “ ” “ ” . . ISO/IEC Guide 99, 2.3 3.40 (measurement) 1 “ ” “ ” . . 2 . 3 , . 4 . ISO/IEC Guide 99, 2.1 . 3.41 (measurement method) 1 (3.44) . 2 . IEC 60050 300 . ISO/IEC Guide 99, 2.5 KS P ISO 18113 1

15、:2012 10 3.42 (measurement model) (sigmoidal) 4- 1 h(Y, X1, K, Xn) 0 . Y X1, K, Xn . 2 , . 3 . ISO/IEC Guide 99, 2.48 3.43 (measurement principle, principle of measurement) a) b) c) (digoxin) , , . ISO/IEC Guide 99, 2.4 3.44 (measurement procedure) , 1 . 2 . ISO/IEC Guide 99, 2.6 3.45 (measurement result) 1 , (A.3.23) . , . 2 . . 3 VIM , , . ISO/IEC Guide 99, 2.9 KS P ISO 18113 1:2012 11 3.46 (measuring interval) 1 . 2 (A.3.14) . A.2.8 3 A.2.11 . ISO/IEC Guide 99, 4.7 3.47 (medical device) , , , , , , , , , , , , , , , (physiological process) , , , , . KS P ISO 13485, 3.7 1 “ ” . 2 37