1、 , (EACC) EURO-ASIAN COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (EASC) 3 - 2- (ISO 11140-3:2000, IDT) 2013 ISO 11140-3 2011 ISO 11140-3-2011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ 4 13 2011 . 1340- ISO 11140-32
2、011 1 2013 . 5 ISO 11140-3:2000 Sterilization of health care products Chemical indicators Part 3: Class 2 indicators for steam penetration test sheets ( . . 3. - 2- ) (IDT). . 11140-32007 6 ( ) . , . C, 2013 ISO 11140-3-2011 III , ISO 11140-3-2011 IV EN 867-3 1997 1. - - , - 2. - -. , , , - , -. , -
3、 . , . - , - , , - ; . - -, . - 285, 3. - N 285. - - : ) ; ) . - , 1, - . - N 285 . - - , , . ISO 11140 - . : - 1 ; ISO 11140-3-2011 V - 2 ; - 3 - 2- ; - 4 2- - - ; - 5 2- - - - . ISO 11140-3-2011 1 3 - 2- Sterilization of care products. Chemical indicators. Part 3. Class 2 indicators for steam pene
4、tration test sheets 2013-01-01 1 ( ), - - (, . .). - 2- ISO 11140-1. , , - - N 285. - -, . 2 . - ( ). ISO 5 -1:1984* Photography- Density measurements- Part 1 : Terms, symbols and notations (. . 1. , ) _ * ISO 5-1:2009 ISO 11140-3-2011 2ISO 5-3:1995* Photography Density measurements Part 3: Spectral
5、 condi-tions (. . 3. () ISO 5-4:1995* Photography Density measurements Part 4: Geometric condi-tions for reflection density (. . 4. ) ISO 187:1990 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (-, . -
6、- ) ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping (. . ) ISO 5457:1999 Technical product documentation Sizes and layout of drawing sheets ( . - ) ISO 5636-3:1992 Paper and board. Determination of air permeance (medium range). Part 3. Bendtsen method ( .
7、 - ( ). 3. ) ISO 9001:1994* Quality management systems Requirements ( -. , , -, ) ISO 11140-1:1995 Sterilization of health care products. Chemical indicators. Part 1. General requirements ( . -. 1. ) N 285:1996 Sterilization Steam sterilizers Large sterilizers (. . ) _ * ISO 5-3:2009 * ISO 5-4:2009
8、* ISO 9001:2008 ISO 11140-3-2011 33 ISO 11140-1 N 285. 4 4.1 ISO 11140-1. 4.1 ISO 187. 5 -: a) , . 30 % . - 20 . ; b) 3,4 / . ISO 5636-3 1,47 ; c) , . - ; d) -; e) ( - ) 0,3. ; f) - , . , - , ; ISO 11140-3-2011 4g) 4 ISO 5457. 6 ( ) 6.1 -: a) 5, - ), 134+1,5 3,5 5 / 121+1,5 15 5 . ; b) , -, , - 2 -
9、(. ). I; c) - (140 2) - 30 . D. . - , - , 6.1, - ), , ; d) - - . F. 6.2 - , . - -, , - 6.1, ), - , - , ISO 11140-3-2011 5 6.1, ) b). - G . 7 7.1 , - (), () . 7.2 , - , , , 1. . - 1 7.3 (. 1), - : a) ; b) ; c) ; ISO 11140-3-2011 6d) ; e) ; f) ; g) ; h) . 5 20 (. 1). 7.4 - , , . - . - . 7.5 - , . 7.6
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