ISO14644-1国际标准—空气洁净度等级划分
空气洁净度等级(N) | 大于或等于所标粒径的粒子最大浓度限值(空气粒子数个/立方米) | |||||
0.1um | 0.2um | 0.3um | 0.5um | 1.0um | 5.0um | |
ISO Class1 | 10 | 2 | ||||
ISO Class2 | 100 | 24 | 10 | 4 | ||
ISO Class3 | 1,000 | 237 | 102 | 35 | 8 | |
ISO Class4 | 10,000 | 2,370 | 1,020 | 352 | 83 | |
ISO Class5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
ISO Class6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
ISO Class7 | 352,000 | 83,200 | 2,930 | |||
ISO Class8 | 3,520,000 | 832,000 | 29,300 | |||
ISO Class9 | 35,200,000 | 8,320,000 | 293,000 |
GB50073-2013 国家标准—空气洁净度等级
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 |
中国GMP(2010年修订)新版GMP附录1 无菌药品.第三章.第九条 洁净区各级别空气悬浮粒子的标准规定如下
洁净度级别 | 悬浮粒子数最大允许数/m3 | 近似对应传统洁净度 | |||
静态 | 动态 | ||||
0.5um | 0.5um | 0.5um | 0.5um | ||
A级 | 3520 | 20 | 3520 | 20 | 100级 |
B级 | 3520 | 29 | 352000 | 2900 | 100级 |
C级 | 352000 | 2900 | 3520000 | 29000 | 10,000级 |
D级 | 3520000 | 29000 | 不作规定 | 不作规定 | 100,000级 |
各国洁净度等级近似对照表
个 / M ≥0.5um | ISO14644-1(1999) | US209E(1992) | US209D(1988) | EECcGMP(1989) | FRANCE AFNOR(1981) | GERMANY VDI 2083 | 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 | - | - | - | - | - |