BioFit now identifies the levels of its clean room products solely according to the International Standards Organization (ISO) 14644-1 classification system, transitioning from a joint denotation over previous years using ISO 14644-1 and the U.S. General Service Administration’s Federal Standard (FS) 209E. It is anticipated that ISO 14644-1 will replace FS209E as the globally accepted standard over the next few years.
The ISO 14644-1 classification system includes nine clean room classes while FS209E contains six classes. The most stringent or "cleanest" class in FS209E is Class 1, while the lowest or "dirtiest" rating is Class 100,000. The ISO system includes classes commensurate to those in FS209E, plus two higher/cleaner classes and one lower/dirtier class. ISO classifications are rated according to how much particulate of specific sizes exist per cubic meter of space, with the highest/cleanest clean room rated as ISO Class 1 and the lowest/dirtiest rated as ISO Class 9. Products in the BioFit MicroTech Collection range from ISO Class 3 (approximately equal to FS209E Class 1) to ISO Class 8 (approximately equal to FS209E Class 100,000). While ISO 14644-1 and FS209E standards do not apply to equipment used in clean rooms, BioFit has always maintained that its clean room products must meet or exceed the particulate cleanliness objectives of these standards.
Refer to the charts below for a comparison of ISO 14644-1 and FS209E classifications as well as particulate counts per ISO class.
Classification System Comparison
ISO 14644-1 Class
FS209E Class
ISO 1
ISO 2
ISO 3
1
ISO 4
10
ISO 5
100
ISO 6
1,000
ISO 7
10,000
ISO 8
100,000
ISO 9
ISO Class Particulate Count by Cubic Meter
ISO 14644-1 Class
Particles per Cubic Meter, in Microns
0.1
0.2
0.3
0.5
1
5
ISO 1
10
2
ISO 2
100
24
10
4
ISO 3
1,000
237
102
35
8
ISO 4
10,000
2,370
1,020
352
83
ISO 5
100,000
23,700
10,200
3,520
832
29
ISO 6
1,000,000
237,000
102,000
35,200
8,320
293
ISO 7
352,000
83,200
2,930
ISO 8
3,520,000
832,000
29,300
ISO 9
35,200,000
8,320,000
293,000
