1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 3 , (ISO 7886-3:2005, IDT) 2013 ISO 7886-3 2011 ISO 7886-32011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ 4 13 2011 . 1264- ISO 7886-32011 1 2013 .
2、5 ISO 7886-3:2005 Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed dose immunization ( . 3. ). . (IDT). 7886-32009 6 ( ) . , . C, 2013 , ISO 7886-32011 III ISO 7886 . . , ( ), , , , . ISO , ISO 7886 , ISO 7886-1 ISO 7886-2 . ISO 7886 , . ISO 7886-1 ISO 7886-4. ISO 7
3、886-2 , . ISO 7886 , , ISO 7886 . ISO 7886-32011 1 3 , Sterile hypodermic syringes for single use. Part 3. Auto-disable syringes for fixed dose immunization 2013-01-01 1 , , , . , . . , ( ISO 595), , (ISO 7886-4), . . ISO 7886-32011 22 : ISO 3696:1987 Water for analytical laboratory use. Specificati
4、on and test methods ( . ) ISO 7864:1993 Sterile hypodermic needles for single use ( ) ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use ( . 1. ) ISO 8537:19911) Sterile single-use syringes, with or without needle, for insulin ( ) ISO 9626 Stainless steel ne
5、edle tubing for the manufacture of medical devices ( ) ASTM D 999:2001 Standard Test Methods for Vibration Testing of Shipping Containers ( ) ASTM D 5276:1998 Test Method for Drop Test of Loaded Containers by Free Fall ( ) 3 ISO 7886-1 ( 3.2), ISO 8537 ( 3.1), : 1) ISO 8537:2007. ISO 7886-32011 33.1
6、 , (auto-disable syringe feature): , . 4 , , 1. 5 5 ISO 7886-1. 6 , , - . 7 , , 5 / , , , , . 0,1 /. ISO 7886-32011 48 8 ISO 7886-1 11.4 ISO 7864. 9 (20 5) C (27 5) C, , , , (. ), , 1. 1 , , % , , 0,05 0,2 . 20 0,025 . 0,2 2 . 5 0,07 10 10.1 : . . 10.2 10.4 ISO 7886-1. 11 11.1 ISO 7886-32011 5 , , ,
7、 5 % , ( 20 % , ). 11.2 11.2 ISO 7886-1. 1 - ( ); 2 - ; 3 - ; 4 - ; 5 - , ; 6 - ; 7 - ; 8 - ; 9 - ; 10 - ; 11 - ; 12 - ; 13 - - , , . 1 , ISO 7886-32011 612 - 12.1 , . , ISO 7886-1, , ISO 8537, B, . , . . , . , ( ) 8 . 12.2 12.2 ISO 7886-1. 12.3 12.3 ISO 7886-1. 13 13.1 ISO 7886-32011 7 ISO 7864. IS
8、O 9626. 13.2 , . , . 14 14.1 E ISO 8537 , 1. 14.2 - F ISO 8537 D ISO 7886-1 , (). B ISO 8537 B ISO 7886-1 , () . 4.2 ISO 8537. 14.3 , . - . (), ISO 7886-32011 8 , , , , : - ; - 50 % ; - . , , : a) ; b) C, . 100 100 / 100 300 . 14.4 ASTM D999-01 ASTM D5276-98. 14.5 E ISO 7886-1. 15 ISO 7886-32011 915.1 15.1 ISO 8537. 15.2 15.2 ISO 8537. 15.3 15.3 ISO 8537. 16 16.1 16.1.1
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