KS P ISO 18113-2-2012 In vitro diagnostic medical devices－Information supplied by the manufacturer (labelling)－Part 2：In vitro diagnostic reagents for professional use.pdf

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

2、2 1 3 .2 4 2 4.1 2 4.2 .2 5 .2 5.1 .2 5.2 2 5.3 .2 5.4 2 5.5 .3 5.6 .3 5.7 3 5.8 .3 6 .4 6.1 4 6.2 .4 6.3 4 6.4 .4 6.5 4 6.6 .4 6.7 5 6.8 .5 7 5 7.1 .5 7.2 5 7.3 5 7.4 .6 7.5 .6 7.6 .6 7.7 .6 7.8 6 7.9 .6 7.10 .6 7.11 , 7 7.12 7 7.13 7 KS P ISO 18113 2:2012 ii 7.14 .7 7.15 7 7.16 8 7.17 8 7.18 9 7.1

3、9 9 10 KS P ISO 18113 2:2012 iii KS P ISO 18113 “ ( )” . 1： 2： 3： 4： 5： . . , , . , , . KS P ISO 18113 2:2012 iv 2009 1 ISO 18113 2, In vitro diagnostic medical devices Information supplied by the manufacturer(labelling) Part 2： In vitro diagnostic reagents for professional use . KS P ISO 18113 2:20

4、12 ( ) 2： In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 2： In vitro diagnostic reagents for professional use 1 . . , . (label) . . a) b) 2 . . ( ) . KS P ISO 18113 1, ( ) 1： KS X ISO 8601, ISO 14971, Medical devices Application of risk management to me

5、dical devices ISO 15223 1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1： General requirements EN 980, Symbols for use in the labelling of medical devices KS P ISO 18113 2:2012 2 3 KS P ISO 18113 1 . 4 4.1 KS P ISO 18113 1 . , ISO 1522

6、3 1 EN 980 . 4.2 , , , , , . 5 5.1 . (EU) (EC) “EC ” . 8 . 5.2 5.2.1 . , . , 5.2.2 (batch code) . , . 5.3 , , (reconstitution) / . 5.4 KS P ISO 18113 2:2012 3 , . 5.5 . “ ” ： “ ” 5.6 , . 1 “2 8 ” “2.8 ” “-18 ” “-18 ” . 2 , , . 3 . 5.7 . “ , , ( )” . KS X ISO 8601 . “0000 00 00 ” “0000 00 ” , . , , .

7、 5.8 , . , , . KS P ISO 18113 2:2012 4 , . 6 6.1 6.1.1 5. . 6.1.2 , (6.4), (6.5), (6.6) . 6.2 . . 6.3 6.3.1 . 6.3.2 . 6.4 , . , , , 6.5 . “ ” ： “ ” 6.6 , . , , . . KS P ISO 18113 2:2012 5 6.7 5.7 , . 6.8 , . , , . , . 7 7.1 . “EC ” . 8 . 7.2 . , . , 7.3 , , , , . , . , . . , (TSH) 50 (PSA) Borrelia

8、Burgdorferi IgM KS P ISO 18113 2:2012 6 7.4 ( , , ), (indicator) / . 7.5 (traceability) / . KS P ISO 175111 KS P ISO 181533 / . . 7.6 , , , . 1 . 2 (phosphate buffer) 10 mM 7.7 . . 7.8 . , , , 7.9 . , . 7.10 , . KS P ISO 18113 2:2012 7 , , . , , . ISO 14971 . “ ” . ISO 14971 . , . . , . 7.11 , , / .

9、 , . 7.12 . , . 7.13 . , . , 7.14 , . . 7.15 KS P ISO 18113 2:2012 8 , , . 1 “ ” , , . . 2 (organism) , ( ) . 3 (color chart) 7.16 7.16.1 (KS P ISO 18113 1 A ). ： , ( ), ( , ). . . . 7.16.2 , (KS P ISO 18113 1 A ). , , 7.16.3 , . 5 mmol/L 500 mmol/L 7.17 , . KS P ISO 18113 2:2012 9 . 6, 7 10 17 . .

10、7.18 . a) b) , c) d) (carryover) ISO 14971 . “ ” . ISO 14971 . 7.19 . , KS P ISO 18113 2:2012 10 1 KS P ISO 17511, 2 ISO 18113 3, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 3： In vitro diagnostic instruments for professional use 3 KS P ISO 18153, 4

11、ISO/IEC Directives, Part 2： Rules for the structure and drafting of International Standards 5 EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use 6 CLSI C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approv

12、ed Guideline Second Edition, CLSI: Wayne, PA, USA, 2000 7 CLSI GP10-A, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline, CLSI: Wayne, PA, USA, 1995 8 Directive 98/79/EC of the European Parliament and the Council of 27 Oct

13、ober 1998 on in vitro diagnostic medical devices, Official Journal of the European Union L331, 7 December 1998 9 Global Harmonization Task Force(GHTF), Labelling for Medical Devices, Final Document GHTF/SG1/N43:2005, 3 June 2005 10 DYBKAER, R. and SOLBERG, H.E., Approved recommendations(1987) on the

14、 theory of reference values. Part 6： Presentation of observed values related to reference values, J. Clin. Chem. Clin. Biochem., 25, pp. 657 662, 1987 11 GALEN, R.S. and GAMBINO, S.R., Beyond Normality： The Predictive Value and Efficiency of Medical Diagnoses, Wiley Biomedical Publication, 1975 12 P

15、ETITCLERC, C. and SOLBERG, H.E., Approved recommendation(1987) on the theory of reference values. Part 2： Selection of individuals for the production of reference values, J. Clin. Chem. Clin. Biochem., 25, pp. 639 644, 1987 13 POULSEN, O.M., HOLST, E. and CHRISTENSEN, J.M., Calculation and applicati

16、on of coverage intervals for biological reference values (Technical Report) A supplement to the approved IFCC recommendation (1987) on the theory of reference values, Pure Appl. Chem., 69(7) pp. 1601 1611, 1997 14 SOLBERG, H.E., Approved recommendation(1986) on the theory of reference values. Part 1

17、： The concept of reference values, Clin. Chim. Acta.,167, pp. 111 118, 1987 15 SOLBERG, H.E., Approved recommendations(1987) on the theory of reference values. Part 5：Statistical treatment of collected reference values. Determination of reference limits. J. Clin. Chem. Clin. Biochem., 25, pp. 645 65

18、6, 1987 16 SOLBERG, H.E. and PETITCLERC, C., Approved recommendation(1988) on the theory of reference values. Part 3： Preparation of individuals and collection of specimens for the production of reference values, Clin. Chim. Acta., 177(3), pp. S3 S11, 1988 17 SOLBERG, H.E. and STAMM, D. Approved rec

19、ommendation on the theory of reference values. Part 4： Control of analytical variation in the production, transfer, and application of reference values. Eur. J. Clin. Chem. Clin. Biochem., 29, pp. 531 535, 1991 ()2： 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 18113 2:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS In vitro diagnostic medical devices Information supplied by the manufacturer (labelling)Part 2： In vitro diagnostic reagents for professional use ICS 11.100.10