ISO 14644-1 cleanroom standards
| Class | maximum particles/m3 | FED STD 209E equivalent |
|||||
|---|---|---|---|---|---|---|---|
| ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥1 µm | ≥5 µm | ||
| ISO 1 | 10 | 2.37 | 1.02 | 0.35 | 0.083 | 0.0029 | |
| ISO 2 | 100 | 23.7 | 10.2 | 3.5 | 0.83 | 0.029 | |
| ISO 3 | 1,000 | 237 | 102 | 35 | 8.3 | 0.29 | Class 1 |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | 2.9 | Class 10 |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
| ISO 6 | 1.0×106 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | 1.0×107 | 2.37×106 | 1,020,000 | 352,000 | 83,200 | 2,930 | Class 10,000 |
| ISO 8 | 1.0×108 | 2.37×107 | 1.02×107 | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
| ISO 9 | 1.0×109 | 2.37×108 | 1.02×108 | 35,200,000 | 8,320,000 | 293,000 | Room air |
US FED STD 209E cleanroom standards
| Class | maximum particles/ft3 | ISO equivalent |
||||
|---|---|---|---|---|---|---|
| ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥5 µm | ||
| 1 | 35 | 7.5 | 3 | 1 | 0.007 | ISO 3 |
| 10 | 350 | 75 | 30 | 10 | 0.07 | ISO 4 |
| 100 | 3,500 | 750 | 300 | 100 | 0.7 | ISO 5 |
| 1,000 | 35,000 | 7,500 | 3000 | 1,000 | 7 | ISO 6 |
| 10,000 | 350,000 | 75,000 | 30,000 | 10,000 | 70 | ISO 7 |
| 100,000 | 3.5×106 | 750,000 | 300,000 | 100,000 | 700 | ISO 8 |
GMP EU cleanroom classification
EU GMP guidelines are more stringent than others, requiring the cleanroom to meet particle counts at operation (during manufacturing process) and at rest (when manufacturing process is not carried out, but room AHU is on).
| Class | maximum particles/m3 | |||
|---|---|---|---|---|
| At Rest | At Rest | In Operation | In Operation | |
| 0.5 µm | 5 µm | 0.5 µm | 5 µm | |
| Grade A | 3,500 | 0 | 3,500 | 0 |
| Grade B | 3,500 | 0 | 350,000 | 2,000 |
| Grade C | 350,000 | 2,000 | 3,500,000 | 20,000 |
| Grade D | 3,520,000 | 29,000 | n/a | n/a |
