1、 4 2- - (ISO 11140-4:2001, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 11140-42011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 40 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJ 4 13 2011 . 1281- ISO 11140-42011 1 2013 .5 ISO 11140-4:2001 Sterilization
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4、roducts. Chemical indicators.Part 4. Class 2 indicators for steam penetration test packs1 2- , () - , (, . .).2-,. . , - , . , . - - N 285 (. ISO 11134). N 285.2 . -().ISO 5-1:1984* Photography Density measurements Part 1: Terms, symbols and notations(. . 1. , )ISO 5-3:1995* Photography Density meas
5、urements Part 3: Spectral conditions (. . 3. ()ISO 5-4:1995* Photography Density measurements Part 4: Geometric conditions for reflectiondensity (. . 4. - )* ISO 5-1:2009.* ISO 5-3:2009.* ISO 5-4:2009.1 ISO 11140-42011 20130101ISO 187:1990 Paper, board and pulps standard atmosphere for conditioning
6、and testing andprocedure for monitoring the atmosphere and conditioning of samples (, . - - )ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping(. . )ISO 9001:1994* Quality management systems Requirements ( . - , , , )ISO 10012-1:1992* Quality assurance requi
7、rements for measuring equipment Part 1: Metrologicalconfirmation system for measuring equipment ( - ( ). 1. )ISO 11134:1994* Sterilization of health care products. Requirements for validation and routine control.Industrial moist heat sterization ( . - . )ISO 11140-1:1995*4Sterilization of health car
8、e products. Chemical indicators. Part 1. Generalrequirements ( . . 1. -)ISO 11140-3:2000*5Sterilization of health care products Chemical indicators Part 3: Class 2indicators for steam penetration test sheets ( . -. 3. - 2- )IEC 60584-2:1982 + 1:1989 Thermocouples. Part 2: Tolerances ( 2: )IEC 60751:
9、1983 + 1:1986*6Industrial platinium resistance thermometer sensors ( )N 285:1996*7Sterilization Steam sterilizers Large sterilizers (. -. )3 :3.1 (air pocket): - , .3.2 (chamber reference temperature): , - . .3.3 (defined end-point): , .3.4 (dry saturated steam): - 0,9 1,0 3,5 , - , N 285.3.5 (expos
10、ure time): , - .3.6 (graduated response): - , .* ISO 9001:2008.* ISO 10012:2003.* ISO 17665-1:2006.*4 ISO 11140-1:2005.*5 ISO 11140-3:2007.*6 IEC 60751:2008.*7 EN 285:2008.2 ISO 11140-420113.7 (indicator): , -.3.8 (indicator reagent): , (ISO 11140-1, 3.4).3.9 (indicator system): , .3.10 (pre-assembledpack):, , .3.11 (reference fault period): 30- , ,
