上海办公室装修公司

各国洁净室标准 
■美国联邦标准（ USA Federal Standard          ） 209E    （ 1992 年） 
  洁净度等级                                  粒径 (um) 
                    0.1         0.2          0.3           0.5          5.0 
       1           35.0         7.50         3.00          1.00         NA 
      10           350          75.0         30.0          10.0         NA 
      100          NA           750          300           100          NA 
     1000          NA           NA           NA            1000         7.0 
    10000          NA           NA           NA           10000        70.3 
    100000         NA           NA           NA           100000        700 
单位：尘埃数量个 /ft3 
■中国药品生产洁净室（区）的空气洁净度标准 
  洁净度级别           尘埃最允许数 /平方米                       微生物最大允许数 
                  ≥0.5um         ≥5um      浮游菌个 /立方米沉降菌个 /皿.30min 
      100          3500            0               5                 1 
    10000         350,000        2,000            100                3 
    100000       3,500,000       20,000           500               10 
    300000       10,500,000      61,800           NA                15 
国家药品监督管理局 1999           年 8   月 1  日发布实施 
■基于≥ 0.5um     粒径的各国洁净度等级近似对照表 
                           US       US       EEC    FRANCE  GERMANY        JAPAN 
 个 /M 3        ISO 
                          209E     209D     GGMP     AFNOR     VDI 2083     JAOA 
  ≥0.5um   14644-1(1999) 
                          (1992)   (1988)   (1989)    (1981)     (1990)     (1989) 
     1           -          -        -         -        -          -          - 
    3.5         2           -        -         -        -          0          2 
   10.0          -         M1        -         -        -          -          - 
   35.3         3         M1.5       1         -        -          1          3 

   100           -          M2          -         -         -           -            - 

    353           4          M2.5       10         -         -           2            4  

   1,000          -          M3          -         -         -           -            -  

   3,530          5          M3.5       100      A+B       4,000         3            5  

  10,000          -          M4          -         -         -           -            -  

  35,300          6          M4.5      1,000     1,000       -           4            6  

  100,000         -          M5          -         -         -           -            -  

  353,000         7          M5.5     10,000       C      400,000        5            7  

 1,000,000        -          M6          -         -         -           -            -  

 3,530,000        8          M6.5     100,000      D     4,000,000       6            8  

10,000,000        -          M7          -         -         -           -            -  

■洁净室及洁净区空气中悬浮粒子洁净度等级  

      空气洁净度                       大于或等于表中粒径的最大浓度限值 (pc/m3)  

       等级 (N)              0.1um       0.2um       0.3um      0.5um       1um        5um  

           1                10           2  

           2                100          24          10         4  

           3               1000         237         102         35          8  

           4               10000        2370        1020       352         83  

           5              100000       23700       10200       3520        832       29  

           6               1000000    237000      102000      35200       8320       293  

           7                                                  352000     83200      2930  

           8                                                 3520000     832000     29300  

           9                                                35200000    8320000    293000  

国家标准 GB50073-2001