■ 美国联邦标准（USA Federal Standard）空气中微粒的洁净等级对照空气微粒洁净等级 （每立方米，每立方英尺）微粒的最大浓度限值
|
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(百级) |
100 |
M3.5 |
ISO5 |
100,000 |
26,500 |
10,600 |
100 |
3,530 |
29 |
|
6(千级) |
1,000 |
M4.5 |
ISO6 |
1,000,000 |
265,000 |
106,000 |
1000 |
35,300 |
293 |
|
7(万级) |
10,000 |
M5.5 |
ISO7 |
|
|
|
10000 |
353,000 |
2,930 |
|
8(十万级) |
100,000 |
M6.5 |
ISO8 |
|
|
|
100000 |
3,530,000 |
29,300 |
|
9 |
|
|
ISO9 |
|
|
|
1000000 |
35,300,000 |
293,000 |
|
|
|
|
洁净度级别 |
尘埃最允许数/立方米 |
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 |
洁净网
■ 基于≥0.5um粒径的各国洁净度等级近似对照表
|
个/M3≥0.5um |
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 |
- |
- |
- |
- |
- |
|
|
空气洁净度等级(N) |
大于或等于表中粒径的最大浓度限值(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（十级） |
10000 |
2370 |
1020 |
352 |
83 |
|
|
5（百级） |
100000 |
23700 |
10200 |
3520 |
832 |
29 |
|
6（千级） |
1000000 |
237000 |
102000 |
35200 |
8320 |
293 |
|
7（万级） |
|
|
|
352000 |
83200 |
2930 |
|
8（十万级） |
|
|
|
3520000 |
832000 |
29300 |
|
9（一百万级） |
|
|
|
35200000 |
8320000 |
293000 |
|
|
国家标准GB50073-2001 | |
