GOST R ISO 19001-2013 In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology《体外诊断医疗器械 制造商提供生物着色用体外诊断.pdf

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1、 19001 2013 IN VITRO , in vitro, ISO 19001:2002 In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (IDT) 2014 190012013 II 27 2002 . 184- , 1.02004 . 1 - . . . , 4 2 380 in vitro 3 25 2013 . 1201-. 4 19001:2002 in vi

2、tro. , in vitro (ISO 19001:2002 In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology). 1.5 ( 3.5). , 5 1.02012 ( 8). , . () . , (gost.ru) , 2014 , 190012013 1 IN VITRO , in vitro, In vitro diagnostic medical devices. I

3、nformation supplied by the manufacturer with in vitro diagnostic reagents for staining in biology 20140801 1 , , . , , , , . , , , . 2 : O 31-8, . 8. (ISO 31-8, Quantities and units Part 8: Physical chemistry and molecular physics) O 1000, (ISO 1000, SI units and recommendations for the use of their

4、 multiples and of certain other units) E 375:2001 , in vitro (EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use) 376:2001 , in vitro (N 376:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing) ,

5、1 , . , , . , , (). , , , , , . , , , , . 3 : 3.1 , (information supplied by the manufacturer): , , , in vitro. 3.2 (label): , , . 190012013 2 EN 375 3.3 in vitro (in vitro diagnostic reagent): , in vitro, in vitro , , , , . . 3.4 (staining): . 3.5 (dye): , , , . (/ ) 400 800 . ( - ). , . , . 3.6 ,

6、(stain): , . . 3.6.1 (stock solution of stain): , . . 3.7 (chromogenic reagent): , , , in situ. : ) ; b) . 3.8 (fluorochrome): , . 3.9 (antibody): , - . , . 3.9.1 (polyclonal antibody): , . 3.9.2 (monoclonal antibody): , . 3.10 (nucleic acid probe): , . 3.11 (lectin): , . 190012013 3 4 , 4.1 4.1.1 ,

7、 , , , , O 31-8, O 1000, E 375 E 376. , E 375. , , , 4.1.2, 4.1.3 4.1.4, , . 4.1.2 CAS , . 1 CAS (CAS). , . 2 5- , .I. . 4.1.3 - , , . , , : a) , ; b) (/) , - ; c) ; : d) ( , ); e) ; f) , . 4.1.4 , ( ). : a) () , , : 1) ; 2) - ; 3) ; 4) ; b) , , , , , , , ; ) (), () , ; d) (); e) , , . 190012013 4 4.2 4.2.1 , , , : ) , , (), , ; ; , , / (/). 4.2.2 , , : ; ( ). 4.2.3 , , : a) ( ), CD. , , , , , , ; b) , ( ), ; ) -, ;

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