1、 1 ISO 14698-1:2003Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods(IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) 14698-12005102004/142, - 1.092 . - 1.297 . , . , , - 1 - () 184 458 2 3 , (- 27 22 20
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4、d environments. Biocontamination control. Part 1. General principles and methods 200601011 - . , - , , . .2 : 14644-1:1999 . 1. - / 51:1999 . 9000:2001 . 14698-2:2003 . . 2. 14644-4:2001 . 4. , 14971:2001 . 15161 9001:2000 61025:1990 60812:1985 7218 :1996 31 3 .3.1 3.1.1 (action level): , .1 14698-1
5、2005 3.1.2 (alert level): -, - , , .3.1.3 : (bioaerosol): , .3.1.4 (biocontamination): , , , -, , .3.1.5 (cleanroom): , , , , , , , - , , . 14644-1, 2.1.13.1.6 (contact device): , - , , .3.1.7 (contact plate): -.3.1.8 (control point): , - , - .3.1.9 (controlled environment): , - .3.1.10 (corrective
6、action): , .3.1.11 (Formal System): -, , .3.1.12 (hazard): . / 51, 3.53.1.13 (impact sampler): , .3.1.14 (impingement sampler): , - .3.1.15 (qualification): , , ( -, , , ) .3.1.16 (risk): . / 51, 3.23.1.17 (risk zone): , , ( ) .3.1.18 (settle plate): (-, ), , - .3.1.19 (swab): , - , , - .3.1.20 (tar
7、get level): , - , .3.1.21 (validation): - , , , -. 9000, 3.8.52 14698-120053.1.22 (verification): - , . 9000, 3.8.4 () - , , . . -.3.1.23 (viable particle): , - .3.1.24 (viable unit, VU): , . , , , , (). - .3.2 3.2.1 (as-built): , , , , . 14644-1, 2.4.13.2.2 (at-rest): , - , . 14644-1, 2.4.23.2.3 (operational): , , , -. 14644-1, 2.4.34 4.1 , . , . 14971 1. - 15161 24. - 61025, 60812 () . .4.2 :) , - ;b) , , , - ;) , ;d) ;) , , - , - ;f)
