1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 2 (ISO 11138-2:1994, IDT) 2013 ISO 11138-2 2012 ISO 11138-22012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 00497 ( 3166) 00497 AZ AM BY KZ KG MD - RU TJ TM UZ UA 4 19 2012 . 1931- ISO
2、 11138-22012 1 2015 . 5 ISO 11138-2:1994 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization ( . . 2. ). (IDT). . 11138-22000 6 ( ) . , . C, 2013 , ISO 11138-22012 III , . ISO 11138-1 , , . . . . / . - , , . , . . . , . ISO 111
3、38-22012 1 2 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization 2015-01-01 1 1.1 - , - 20 65 . 2 : ISO 11138-1:1994 Sterilization of health care products. Biological indicators. Part 1. General requirements ( . . 1. ) 3 ISO 11
4、138-1. 4 ISO 11138-1, , . ISO 11138-22012 25 - - Bacillus subtilis ISO 11138. Bacillus subtilis NCTC 10073 CIP 7718 . Subtilis 9372. 6 35 % . 7 ISO 11138-1, 4.4. : 55 ; 70 %; 800 /; 6 . . 8 8.1 - 50 % , , , . ISO 11138-22012 38.2 - -, , , , - , . , 50 % 300 % , , , . 8.3 , , 1106 0,1106. , , , , , .
5、 9 9.1 D 0,5 . 9.2 . 9.3 D, / MPN (ISO 11138-1, ), - 12,5 (600 30) /, (60 10) % (30 1) , / 2,5 , , (54 1) . ISO 11138-22012 410 . . . ISO 11138-22012 5 () .1 .1.1 , .1, 1 120 10 , 6 . .1.2 10 (100 ), . , 99,9 % 0,5 . .1.3 60 , 10 (100 ) 60 . .1.4 . .1 , / 600 30 , 30 1 54 1 , % 60 10 ISO 11138-22012
6、 6.1.5 . .1.6 , , . 50 % , . , 1 , , 0,5 . .2 .2.1 , . .2.2 (30 1) (54 1) . .2.3 , , . .2.4 : a) (10 0,4) (100 4 ); b) (60 10) %; 28 30 ; c) (600 30) / 60 . . d) ; e) (10 0,4) (100 4 ) 60 ( ) ; ISO 11138-22012 7f) ) . .2.5 . .3 ISO 11138-1. ISO 11138-22012 8 () .1 - ISO 11138-1:1994 . . 1. IDT ISO 11138 - 1 2012 . . 1. : - IDT . ISO 11138-22012 9 637.132.4:715.478:658.513:006.354 11.080 26 IDT : , , , , ,
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