1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 3 (ISO 11138-3:1995, IDT) 2013 ISO 11138-3 2012 ISO 11138-32012 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 41-2012 24 2012 .) : ( 3166) 00497 ( 3166) 00497 AZ BY KZ KG MD - RU TJ TM UZ UA AM 4 19 2012 . 1925- IS
2、11138-32012 1 2015 . 5 ISO 11138-3:1995 Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization ( . . 3. ). C (IDT). 11138-32000 . 6 ( ) . , . . C, 2013 , ISO 11138-32012 III , . . . / . - , , , . , . . . , . ISO 11138-32012 1 _ 3 Steril
3、ization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization _ 2015-01-01 1 1.1 - , 100 . 2 : ISO 11134:1994 Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterization ( . . ) ISO 111
4、38-1:1994 Sterilization of health care products. Biological indicators. Part 1. General ( . . 1. ) 3 ISO 11138-1 . ISO 11138-32012 2_ 3.1 () z: , D 10 . 4 ISO 11138-1, , . 5 - - Bacillus stearothermophilus , . Bacillus stearothermophilus NCTC 10003, DSM 494, . stearothermophilus 12980, DSM 22 . stea
5、rothermophilus CIP 52.81, DSM 5934, 7953, NCTC 10007 . 6 - - 35 % . 7 ISO 11138-1, 4.4. : ISO 11138-32012 3- , 5 . 145 ; - , . 30 . , . 8 8.1 - , 50 % , , , . 8.2 -, , () . , 50 % 300 % . 8.3 , , - 1 105 0,1 105. - 1 105 9.3. ISO 11138-32012 4 / , , , , , . 1 106. 9 9.1 D 0,5 . 9.2 . 9.3 D - , , , M
6、PN (. 5 , D ISO 11138-1), 1,5 (1211) . D, , 10 . 9.4 D - 110 130 . z, 6 0,1 . z . 10 . . . ISO 11138-32012 5 () .1 .1.1 5 180 1 : - ( 110 145 ) 0,5 ; - ( 140 413 ) 2,5 ; - ( 4 100 ) 0,5 10 , . .1.2 , 5 5 , . / . .1.3 , , 99,9 % 0,5 . .1.4 . .1.5 . ISO 11134. .1.6 , ; 50 % . , ISO 11138-32012 6 1, 0,
7、5 . .1.7 10 . .1.8 100 10 , ( ) 5 . .2 .2.1 , . .2.2 . .2.3 , , . .2.4 : a) (4,5 0,5) ( 10 ) 5 ; ) . . c) ; d) (103,5) ( ), 5 . .2.5 . . ISO 11138-1. ISO 11138-32012 7 () z , 9.3, z, , Z =2 - 1 lg D1 - lg D2 D1 D2 , 1 2 (. 9.4). ISO 11138-32012 8 () .1 - ISO 11134:1994 . . * ISO 11138-1:1994 . . 1. IDT ISO 11138-1-2012 . . 1. * . . . : - IDT . ISO 11138-32012 9 637.132.4:715.478:658.513:006.354 11.080 26
