行業(yè)規(guī)范當(dāng)前位置：行業(yè)規(guī)范
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■ 美國聯(lián)邦標(biāo)準(zhǔn)（USA Federal Standard）209E（1992年）
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潔凈度級別
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粒 徑 (um)
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|
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0.1
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0.2
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0.3
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0.5
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5.0
|
|
1
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35.0
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7.50
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3.00
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1.00
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NA
|
|
10
|
350
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75.0
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30.0
|
10.0
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NA
|
|
100
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NA
|
750
|
300
|
100
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NA
|
|
1000
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NA
|
NA
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NA
|
1000
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7.0
|
|
10000
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NA
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NA
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NA
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10000
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70.3
|
|
100000
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NA
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NA
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NA
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100000
|
700
|
|
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單位：塵埃數(shù)量個/ft3
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|
■ 中國藥品生產(chǎn)潔凈室（區(qū)）的空氣潔凈度標(biāo)準(zhǔn)
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潔凈度級別
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塵埃最允許數(shù)/平方米
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微生物最大允許數(shù)
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|
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≥0.5um
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≥5um
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浮游菌個/立方米
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沉降菌個/皿.30min
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|
100
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3500
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0
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5
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1
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|
10000
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350,000
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2,000
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100
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3
|
|
100000
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3,500,000
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20,000
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500
|
10
|
|
300000
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10,500,000
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61,800
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NA
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15
|
|
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國家藥品監(jiān)督管理局1999年8月1日發(fā)布實(shí)施
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■ 基于≥0.5um粒徑的各國潔凈度等級近似對照表格
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個/M3≥0.5um
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ISO
14644-1(1999)
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US
209E(1992)
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US
209D(1988)
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EEC
GGMP(1989)
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FRANCE
AFNOR(1981)
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GERMANY
VDI 2083(1990)
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JAPAN
JAOA(1989)
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1
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-
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-
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-
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-
|
-
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-
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-
|
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3.5
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2
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-
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-
|
-
|
-
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0
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2
|
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10.0
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-
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M1
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-
|
-
|
-
|
-
|
-
|
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35.3
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3
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M1.5
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1
|
-
|
-
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1
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3
|
|
100
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-
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M2
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-
|
-
|
-
|
-
|
-
|
|
353
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4
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M2.5
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10
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-
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-
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2
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4
|
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1,000
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-
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M3
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-
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-
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-
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-
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-
|
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3,530
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5
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M3.5
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100
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A+B
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4,000
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3
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5
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10,000
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-
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M4
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-
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-
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-
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-
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-
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35,300
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6
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M4.5
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1,000
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1,000
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-
|
4
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6
|
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100,000
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-
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M5
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-
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-
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-
|
-
|
-
|
|
353,000
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7
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M5.5
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10,000
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C
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400,000
|
5
|
7
|
|
1,000,000
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-
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M6
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-
|
-
|
-
|
-
|
-
|
|
3,530,000
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8
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M6.5
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100,000
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D
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4,000,000
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6
|
8
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10,000,000
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-
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M7
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-
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-
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-
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-
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-
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|
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■ 潔凈室及潔凈區(qū)空氣中懸浮粒子潔凈度等級
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空氣潔凈度等級(N)
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大于或等于表中粒徑的最大濃度限值(pc/m3)
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|
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0.1um
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0.2um
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0.3um
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0.5um
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1um
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5um
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|
1
|
10
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2
|
|
|
|
|
|
2
|
100
|
24
|
10
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4
|
|
|
|
3
|
1000
|
237
|
102
|
35
|
8
|
|
|
4
|
10000
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2370
|
1020
|
352
|
83
|
|
|
5
|
100000
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23700
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10200
|
3520
|
832
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29
|
|
6
|
1000000
|
237000
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102000
|
35200
|
8320
|
293
|
|
7
|
|
|
|
352000
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83200
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2930
|
|
8
|
|
|
|
3520000
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832000
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29300
|
|
9
|
|
|
|
35200000
|
8320000
|
293000
|
|
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國家標(biāo)準(zhǔn)GB50073-2001
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