Equivalence of Standards for Controlled Rooms
Controlled Room Classification StandardsCLEAN ROOMS
Equivalence of international classification standards
| No. of particles > 0.5 µm/m³ (approx.) | US Fed. Std 209E 1992 | EN ISO 14644-1 1996 | France AFNOR NF X 44.101 1981 | European Union Pharmaceutical Industry Guide BPF 1989 | No. of particles > 0.1 µm/m³ (approx.) | |
|---|---|---|---|---|---|---|
| ISO 1 | 10 | |||||
| 1 | 35 | |||||
| 4 | ISO 2 | 100 | ||||
| 10 | M 1 | 350 | ||||
| 35 | M 1.5 | 1 | ISO 3 | 1 000 | ||
| 100 | M 2 | 3 500 | ||||
| 353 | M 2.5 | 10 | ISO 4 | 10 000 | ||
| 1 000 | M 3 | 35 000 | ||||
| 3 530 | M 3.5 | 100 | ISO 5 | 4 000 | A y B | 100 000 |
| 10 000 | M 4 | 350 000 | ||||
| 35 300 | M 4.5 | 1 000 | ISO 6 | 1 000 000 | ||
| 100 000 | M 5 | |||||
| 353 000 | M 5.5 | 10 000 | ISO 7 | 400 000 | C | |
| 1 000 000 | M 6 | |||||
| 3 530 000 | M 6.5 | 100 000 | ISO 8 | 4 000 000 | D | |
| 10 000 000 | M 7 | |||||
| 35 000 000 | ISO 9 | |||||
