1、C 1 (ISO 11140-1:2005, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 11140-12011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 ()3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUUZTJ 4 13 2011 . 1278- ISO 11140-12011 1 2013 .5 ISO 11140-1:2005 Sterilization
2、 ofhealth care products Chemical indicators Part 1: General requirements ( . . 1. ). - .C (IDT). 11140-120096 - , - . () - . , , 2014 -, II ISO 11140-120111 12 13 24 .25 .36 .57 .58 ( 1) 79 ( 3).1010 ( 4) .1011 ( 5) .1112 ( 5) .1213 ( 5) .1314 ( 6) 13 () 15 () .16 () , ISO 11138, 17 D () 21 () 22 ()
3、 23 24III ISO 11140-12011 / -, - , , , c103- c98-, . , - , , , , . , , -(Bowie-Dick), ISO 11140. , , -, , . - . , - , , - . , , ISO 15882, EN 285, ISO 11135 ISO 17665. -, , (. ISO 18472). . -; , - / . ISO 11140 . - :- 1. ;- 2. ;- 3. 2- - ;- 4. 2- - ;- 5. 2- - - .IV ISO 11140-12011 1 Sterilization of
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5、ation ofdates and times ( . . - )ISO 11138 ( ) Sterilization of health care products. Biological indicators. ( - . )ISO 11607 Packaging for terminally sterilized medical devices ( , )1 ISO 11140-12011 ISO 18472 Sterilization of health care products Biological and chemical indicators Test equipment(
6、. . )3 :3.1 (bleed): , - .3.2 (critical variable): - .3.3 (endpoint): , .3.4 (graduated response): , .3.5 (indicator): , - (. ). - .3.6 / (indicator agent/indicator reagent): - () (. ).3.7 (indicator system): , .3.8 (off-set): , - .3.9 (parameter): .3.10 (penetration): , , .3.11 (saturated steam): -
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