Air cleanliness classification standard: ISO14644-1 (international standard)
| Air cleanliness grade (N) | Maximum concentration limit of particles greater than or equal to the marked particle size (particles per cubic meter of air) | |||||
0.1um | 0.2um | 0.3um | 0.5um | 1.0um | 5.0um | |
| ISO Class1 | 10 | 2 | ||||
| ISO Class2 | 100 | 24 | 10 | 4 | ||
| ISO Class3 | 1000 | 237 | 102 | 35 | 8 | |
| ISO Class4 | 10000 | 2,370 | 1,020 | 352 | 83 | |
| ISO Class5 | 100000 | 23,700 | 10,200 | 3,520 | 832 | |
| ISO Class6 | 1000000 | 237,000 | 102,000 | 35,200 | 8,320 | |
| ISO Class7 | 352,000 | 83,200 | ||||
| ISO Class8 | 3,520,000 | 832,000 | ||||
| ISO Class9 | 35,200,000 | 8,320,000 | ||||
| NOTE: Due to the uncertainty involved in the measurement process, no more than three significant concentration figures are required to determine the grade level. | ||||||
Air cleanliness classification standard: GB/T16292-1996 (Chinese standard)
Particle size, value Cleanliness level | Maximum allowable dust quantity/cubic meter | Maximum allowable number of microorganisms | ||
>0.5um | >5.0um | Floating bacteria/cubic meter | Settled bacteria/dish | |
| 100级 | 3,500 | 0 | 5 | 1 |
| 1,000级 | 35,000 | 200 | 50 | 2 |
| 10,000级 | 350,000 | 2,000 | 100 | 3 |
| 100,000级 | 3,500,000 | 20,000 | 500 | 10 |
| 300,000级 | 10,500,000 | 60,000 | 15 | |
美国联邦标准(USA Federal Standard)
Cleanliness level of air particles compared to the maximum concentration limit of air particles (per cubic meter, per cubic foot)
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 | |||
Air cleanliness standards for clean rooms (areas) in pharmaceutical production in China
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 | ||||||
基于≥0.5um粒径的各国洁净度等级近似对照表 | 国家药品监督管理局1999年8月1日发布实施 | |||||||||
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 | - | - | - | - | - |
Cleanliness level of suspended particles in the air of clean rooms and clean areas
空气洁等级(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 | |||
