潔凈度等級標準
潔凈度等級標準之美國聯邦標準(USAFederal Standard)209E (1992年)
潔凈度級別 CleanClass  | 粒  徑Particles Size (μm)  | 
0.1  | 0.2  | 0.3  | 0.5  | 5.0  | 
1  | 35.0  | 7.50  | 3.00  | 1  |    | 
10  | 350  | 75  | 30.0  | 10  |    | 
100  | -  | 750  | 300  | 100  |    | 
1000  | -  |    |    | 1000  | 7.00  | 
10000  | -  |    |    | 10000  | 70.3  | 
100000  | -  |    |    | 100000  | 700  | 
                                                                                                                      單位:塵埃數量個/ft3
 
潔凈度等級標準之ISO14644國際凈化標準
ISO Classification Number(N)  | 粒 徑 Particles Size (μm)  | 
0.1  | 0.2  | 0.3  | 0.5  | 1.0  | 5.0  | 
ISOClass1  | 10  | 2  |    | -  |    |    | 
ISOClass2  | 100  | 24  | 10  | 4  |    |    | 
ISOClass3  | 1000  | 237  | 102  | 35  | 8  |    | 
ISOClass4  | 10000  | 2370  | 1020  | 352  | 83  |    | 
ISOClass5  | 100000  | 23700  | 10200  | 3520  | 832  | 29  | 
ISOClass6  | 1000000  | 23700  | 102000  | 35200  | 8320  | 293  | 
ISOClass7  |    |    |    | 352000  | 83200  | 2930  | 
ISOClass8  |    |    |    | 3520000  | 832000  | 29300  | 
ISOClass9  |    |    |    | 35200000  | 8320000  | 293000  | 
                                                                                                  單位:個/m3
 
潔凈度等級標準之中國藥品生產潔凈室(區)的空氣潔凈度標準
潔凈度等級 CleanClass  | 塵埃*大允許數/立方米 Maximum permit quantity ofparticles per cubic metre  | 塵埃*大允許數/立方米 Maximum permit quantity ofmicrorganism  | 
≥0.5μm  | ≥5μm  | 浮游菌個/立方米  | 沉降菌個/30min  | 
100  | 3,500  | 0  | 5  | 1  | 
1000  | 35,000  | 2,000  | 100  | 3  | 
10000  | 350,000  | 20,000  | 500  | 10  | 
100000  | 3,500,000  | 61,800  | -  | 15  | 
                                                                                     國家藥品監督管理局1999年8月1日發布實施
 
注:1立方米(m3)≈35.3146667立方英尺(ft3)        1 ft3=10×0.10ft3