GOST ISO 14698-2-2005 Cleanrooms and associated controlled environments Biocontamination control Part 2 Evaluation and interpretation of biocontamination data《洁净室和相伴控制环境 生物污染控制 第2部.pdf

1、 2 ISO 14698-2:2003Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation andinterpretation of biocontamination data(IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC) 14698-22005102004/143, - 1.092 . - 1.297 . , . , , - 1 - () -

2、184 - 458 2 3 , (- 27 22 2005 .) : ( 3166) 00497 ( 3166) 00497 AZAMBYGEKZKGMDRUTJTMUZUA - - 4 14698-2:2003 - . . 2. (ISO 14698-2 : 2003 Cleanrooms and associated controlled environments Bioconta-mination control Part 2: Evaluation and interpretation of biocontamination data). , / 209 , , - . , , - ,

3、 5 29 2005 . 234- 14698-22005 1 2006 .6 ( ) - . () - , . - , 2005 -, II 14698-220051 12 13 14 2 () () 7 .8III 14698-22005 . , 14698-1. , . 14698-22005IV 2 Cleanrooms and associated controlled environments. Biocontamination control. Part 2.Evaluation and interpretation of biocontamination data 200601

4、011 , , . , , 14698-1.2 : 14698-1:2003 . -. 1. 14644-1:1999 . 1. 9000:2000 . 3534-1:1993 . . 1. 8258:1991 / 7871:1997 . - CUSUM / 51:1999 . 3 .3.1 (action level): 14698-1.3.2 (alert level): 14698-1. - .3.3 (audit trail): , .3.4 (biocontamination): 14698-1.3.5 (cleanroom): 14644-1, 2.1.1.3.6 (data st

5、ratification): .1 14698-22005 3.7 (estimate): , . 3534-1, 2.513.8 (estimation): ( , ) , - , . 3534-1, 2.493.9 (estimator): , . 3534-1, 2.503.10 (hazard): 14698-1.3.11 (risk): 14698-1 ( / 51, 3.2).3.12 (risk zone): 14698-1.3.13 (target level): 14698-1.3.14 (validation): 14698-1 ( 9000, 3.8.5).3.15 (v

6、iable particle): 14698-1.3.16 (viable unit, VU): 14698-1. , , , , (). - .4 4.1 14698-1 , , , , () - . . :- ;- ;- (, , -, .);- ;- (, , , -, ) ;- , ;- ;- ;- , . : ( ) .4.2 , ( 1)4.2.1 , , - 14698-1, :- , , ;- , , , ;- , - ;- ;2 14698-22005- , - .4.2.2 - . , , . :- ;- ;- ;- () ;- ;- ;- , .4.2.3 , , , ,

7、 - . , , , , . , . , . - () ( , ). , . . , .1 , , -, ( 14698-1):- ;- ;- ;- .c2232 ( 14698-1):- ;- ;- .c2233 :- ;- ;- ;- ;- .c2234 :- ;- , ;- , .c2235 ():- ;- ;- .c2236 /, 1 , 3 14698-220054.3 , ( 2)4.3.1 14698-1. - . , . . , - .4.3.2 , - 14698-1. , , - :- ;- , ;- /;- -;- .1 :- ;- () ;- .c2232 :- : ;- ;- ;- .c2233 :- ;- / .c2234 :- ;- ;- ;- .c2235 :- , ;- , , ;- , , ;- .c2236 /, 2 , 4.3.3 , - , . :- ;- , ();-