1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 1 (ISO 10555-1:1995, IDT) 2013 ISO 10555-1 2011 ISO 10555-12011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 48 22 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ UZ 4 13 2011 . 1287- ISO 10555-12011 1 2013 .
2、5 ISO 10555-1:1995 Sterile, single-use intravascular catheters Part 1: General requirements ( . 1. ). (IDT). 10555.199 . 6 ( ) . , . C, 2013 , ISO 10555-12011 IV ISO 10555-1:1995 . 1. , / 84 . : - 1 ; - 2 ; - 3 ; - 4 ; - 5 . , , ISO 1107098 1. ISO 10555-12011 1 1 Sterile, single-use intravascular ca
3、theters. Part 1. General requirements 2013 - 01 - 01 1 ( ), . . , . 2 : ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ( 6 % () , . 1. ) ISO 594-2:1991 Conical fittings with a 6% (Luer) taper for syringes
4、, needles and certain other medical equipment Part 2: Lock fittings ( 6 % () , . 2. ) ISO 7886-1:1993 Sterile hypodermic syringes for single use Part 1: Syringes for manual use ( . 1. ) ISO 10555-12011 2 ISO 10993-1:1992 Biological evaluation of medical devices Part 1: Guidance on selection of tests
5、 ( . 1. ) 3 : 3.1 : ( ), , - () . 3.2 : , . 3.3 : , . 3.4 : , . 3.5 l: , ( 1). ISO 10555-12011 3l ; 1 ; 2 - ; 3 ; 4 1 3.6 : , . 3.7 : , . 4 4.1 4.2 4.7. ISO 11134 2, ISO 11135 3, ISO 11137 4. ISO 10555-12011 4 4.2 . ISO 10993-1. 4.3 ( ) 2,5 . , , . , . 4.4 , , . 4.5 , , 1. 1 , , 0,55, 0,75 3 0,75, 1
6、,15 5 1,15, 1,85 10 1,85 15 , 0,55 .4.6 4.6.1 , , . ISO 10555-12011 54.6.2 , , . 4.7 , ISO 594-1 ISO 594-2. 5 5.1 5.2. 5.1 0,05 2 0,1 , 2 . 5.2 99 . 99 , . 6 , : a) ; b) ; c) ; d) -; e) ; f) ; g) ; h) ; i) ; j) ; k) , ; l) . . . ISO 10555-12011 6 () .1 , . . .2 .2.1 NaCl = 0,15 /. .2.2 .3 .3.1 . .4
7、, , .2.1, 5 . 30 . 37 C 48 . . , , , . . . .5 : ) () ; b) . ISO 10555-12011 7 () .1 , , , . , . .2 .2.1 , 15 . .3 .3.1 . . : ( ), ( ). 3 . .3.2 2 100 % (37 2) C. .3.3 .3.5. .3.3 . , . .3.4 , , . .3.5 20 / ( .1) , ( ) . ISO 10555-12011 8 .1 , , / 10 200 20 400 25 500 . .3.6 , , .3.2 .3.5 . .3.7 ( ) , : a) .3.2 .3.5 ; b) .3.2 .3.5 , , ; c) b) . .3.8 . .4 : ) () ; ) . ISO 10555-12011 9 () .1 . ( ) . .2 .2.1
