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1.美國聯邦標準（USA Federal Standard）
空氣中微粒的潔凈等級對照
空氣微粒潔凈等級 （每立方米，每立方英尺）微粒的最大濃度限值
|
ISO14644-1
|
FED STD 209E
|
CLASS
|
Number of Par Cubic Meter by Micrometer Size
|
|
ISO Class
|
English
|
Metric
|
|
0.1um
|
0.2um
|
0.3um
|
0.5um
|
0.5um
|
5um
|
|
|
|
|
|
m3
|
m3
|
m3
|
ft3
|
m3
|
|
|
1
|
|
|
ISO1
|
10
|
2
|
|
|
|
|
|
2
|
|
|
ISO2
|
100
|
26
|
10
|
|
4
|
|
|
3
|
1
|
M1.5
|
1SO3
|
1,000
|
265
|
106
|
|
35
|
|
|
4
|
10
|
M2.5
|
ISO4
|
10,000
|
2,650
|
1,060
|
10
|
353
|
|
|
5(百級)
|
100
|
M3.5
|
ISO5
|
100,000
|
26,500
|
10,600
|
100
|
3,530
|
29
|
|
6(千級)
|
1,000
|
M4.5
|
ISO6
|
1,000,000
|
265,000
|
106,000
|
1000
|
35,300
|
293
|
|
7(萬級)
|
10,000
|
M5.5
|
ISO7
|
|
|
|
10000
|
353,000
|
2,930
|
|
8(十萬級)
|
100,000
|
M6.5
|
ISO8
|
|
|
|
100000
|
3,530,000
|
29,300
|
|
9
|
|
|
ISO9
|
|
|
|
1000000
|
35,300,000
|
293,000
|
|
|
|
|
2.中國藥品生產潔凈室（區）的空氣潔凈度標準
|
潔凈度級別
|
塵埃最允許數/立方米
|
微生物最大允許數
|
|
≥0.5um
|
≥5um
|
浮游菌個/立方米
|
沉降菌個/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
|
|
|
國家藥品監督管理局1999年8月1日發布實施
|
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3.基于≥0.5um粒徑的各國潔凈度等級近似對照表
|
個/M3≥0.5um
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ISO
14644-1(1999)
|
US
209E(1992)
|
US
209D(1988)
|
EEC
GGMP(1989)
|
FRANCE
AFNOR(1981)
|
GERMANY
VDI 2083(1990)
|
JAPAN
JAOA(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
|
-
|
-
|
-
|
-
|
-
|
|
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4.潔凈室及潔凈區空氣中懸浮粒子潔凈度等級
|
空氣潔凈度等級(N)
|
大于或等于表中粒徑的最大濃度限值(pc/m3)
|
|
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（十級）
|
10000
|
2370
|
1020
|
352
|
83
|
|
|
5（百級）
|
100000
|
23700
|
10200
|
3520
|
832
|
29
|
|
6（千級）
|
1000000
|
237000
|
102000
|
35200
|
8320
|
293
|
|
7（萬級）
|
|
|
|
352000
|
83200
|
2930
|
|
8（十萬級）
|
|
|
|
3520000
|
832000
|
29300
|
|
9（一百萬級）
|
|
|
|
35200000
|
8320000
|
293000
|
|
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國家標準GB50073-2001
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