Equivalence of Standards for Controlled Rooms

Controlled Room Classification Standards

CLEAN ROOMS

Equivalence of international classification standards

No. of particles > 0.5 µm/m³ (approx.)US Fed. Std 209E 1992EN ISO 14644-1 1996France AFNOR NF X 44.101 1981European Union Pharmaceutical Industry Guide BPF 1989No. of particles > 0.1 µm/m³ (approx.)
ISO 110
135
4ISO 2100
10M 1350
35M 1.51ISO 31 000
100M 23 500
353M 2.510ISO 410 000
1 000M 335 000
3 530M 3.5100ISO 54 000A y B100 000
10 000M 4350 000
35 300M 4.51 000ISO 61 000 000
100 000M 5
353 000M 5.510 000ISO 7400 000C
1 000 000M 6
3 530 000M 6.5100 000ISO 84 000 000D
10 000 000M 7
35 000 000ISO 9