1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 4 , (ISO 7886-4:2006, IDT) 2013 ISO 7886-4 2011 ISO 7886-4 2011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU 4 13 2011 . 1359- ISO 7886-42011 1 2013 . 5
2、ISO 7886-4:2006 Sterile hypodermic syringes for single use Part 4: Syringes with re-use prevention feature ( . 4. , ). . (IDT). 7886-42009 6 ( ) . , . C, 2013 , ISO 7886-4 2011 III ISO 7886 . . , ( ) , , , . ISO , ISO 7886 , , ISO 7886-1 ISO 7886-2 . ISO 7886 , . ISO 7886-1 ISO 7886-3. ISO 7886-2 ,
3、. , . ISO 7886 , , ISO 7886 . ISO 7886-4 2011 1 4 , Sterile hypodermic syringes for single use. Part 4. Syringes with re-use prevention feature 2013-01-01 1 , , , , . , (ISO 595), (ISO 7886-3) . , , . , , . ISO 7886-4 2011 22 : ISO 780:1997 Packaging. Pictorial marking for handling of goods (. ) ISO
4、 3696:1987 Water for analytical laboratory use. Specification and test methods ( . ) ISO 7000 Graphical symbols for use on equipment - Index and synopsis ( , . ) ISO 7864:1993 Sterile hypodermic needles for single use ( ) ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes
5、for manual use ( . 1. ) ISO 8537:19911) Sterile single-use syringes, with or without needle, for insulin ( ) ISO 9626 Stainless steel needle tubing for the manufacture of medical devices ( ) ASTM D999:2001 Standard Test Methods for Vibration Testing of Shipping Containers ( ) ASTM D5276:1998 Test Me
6、thod for Drop Test of Loaded Containers by Free Fall ( ) 3 ISO 7886-1, ISO 8537, 1) ISO 8537:2007. ISO 7886-4 2011 3 : 3.1 , (re-use prevention feature): , , . 4 , - , 1. 1 ( ); 2 ; 3 ; 4 ; 5 , ; 6 ; 7 ; 8 ; 9 ; 10 ; 11 ; 12 ; 13 ISO 7886-1. ISO 7886-4 2011 4 . . , , . 1 , 5 5.1 5.2 5.3. , , , . 5.2
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8、O 7886-1 9.3 ISO 8537, . 12 12.1 , , , , 5 % , ( 20 % , ). 12.2 11.2 ISO 7886-1. 13 - 13.1 , . , ISO 7886-1, , ISO 8537, B, . , . ISO 7886-4 2011 7 , : ) 8 2 ( 2 ); b) 9 2 5 ( 5 ); ) 12,5 5 . 13.2 12.2 ISO 7886-1. 11.3 ISO 8537. 13.3 12.3 ISO 7886-1 11.3 ISO 8537. 14 14.1 ISO 7864. ISO 9626. 14.2 13 ISO 7886-1. 15 15.1 ISO 8537, E, ISO 7886-4 2011 8 , 14.1 ISO 7886-1. ; . 15.2 - ISO 8537, F, ISO 7886-1, D, , (). ISO 8537, B, ISO 7886-1, B, , () . 14.2 ISO 8537. - , . 15.3 , , , , , B. 15.4 ASTM D999-01 ASTM D5276-98. 15.5
