1、 (ISO 7864:1993, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 78642011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJ 4 13 2011 . 1290- ISO 78642011 1 2013 .5 ISO 7864:1993 Sterile hypodermicneedles for si
2、ngle use ( ). - . (IDT). 786420096 ( ) - . , - . - C, 2013 -, II ISO 78642011C1 .12 13 .14 .25 .26 .27 28 .29 210 311 312 .313 .414 515 6() .7() , 8() , . . 9() 1011III ISO 78642011 - , . - , - . ISO 10993-1 . . ISO 10993-1. , , , , , -. , ., , -, ISO 595, ISO 7886-1 1 2, ISO 8537. - .IV ISO 7864201
3、1 Sterile hypodermic needles for single use1 ( ) 0,3 1,2 . , .2 :ISO 594-1:1986 Conical fittings witha6%(Luer) taper for syringes, needles and certain other medicalequipment; Part 1: General requirements ( 6 % () -, . 1. )ISO 594-2:1991* Conical fittings witha6%(Luer) taper for syringes, needles and
4、 certain other medicalequipment;Part2:lockfittings( 6%(),- . 2. )ISO 3696:1987 Water for analytical laboratory use; Specification and test methods ( - . )ISO 6009:1992 Hypodermic needles for single use; colour coding for identification ( - . )ISO 7886-1 Sterile hypodermic syringes for single use; pa
5、rt 1: syringes for manual use ( - . 1. )ISO 8601:2001 Data elements and interchange formats; information interchange; representation ofdates and times ( . . - )ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices ( )3 1 l. 2.* ISO 594-2:1998.1 ISO 78642011 201301011 ; 2
6、 ; 3 ;4 ; l 1 4 , , 300 700 . 2,5- .5 , , - .6 , , 5 / , , - , , . 0,1 /.7 :) , ;b) , . . 0,8 c180 40.8 / ISO 6009.9 9.1 ISO 594-1. (6:100), ISO 594-2.9.2 . - , ISO 6009.2 ISO 7864201110 . , ISO 6009.11 11.1 ISO 9626.11.2 (. l 1) , 1. 1 40c45c432515,11.3 , .11.4 , - . -, . 0,25 .12 , 2,5- .c97 (. 2)
7、 (11 c177 2), - (17 c177 2).3 ISO 78642011d0 ; d1 ; A ; B0 - ; B1 ; B2 ;C0 ; C1 ; C2 ;c97 ;c102 ;c98 ;c1131;c1132 ;c103 2 2 . . . , . , - .13 13.1 , . 2. 2 , , , , 0,30,330,360,40,450,50,55222222222222340,60,70,80,91,11,23440445469694 ISO 7864201113.2 ( ) , ) 3; b) , 80 % ISO 9626 3. 1 c18010 c42. 3
8、 00,01 0,3 0,11 0,13 0,33 0,11 0,15 0,36 0,11 0,15 0,4 0,15 0,19 0,45 0,18 0,23 0,5 0,18 0,23 0,55 0,22 0,27 0,6 0,25 0,29 0,300,7 0,30 0,35 0,370,8 0,40 0,42 0,440,9 0,48 0,49 0,501,1 0,58 0,60 0,681,2 0,70 0,73 0,8314 14.1 . . . :) , ;b) ;) ;d) , .14.2 . .14.3 ( ) - .* 1 (QI) = 101325 ;1 (Q) = 98066,5 .5 ISO 7864201115 15.1 :) 7;b) ;c) - ( );d) / -;) ( ) ;f)
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