Regulatory Classifications 4 ISO CLASS 4 CLEANROOM
ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
(Fed. Std. 209E rating is Class 10). Has no more than 352 particles per cubic meter equal to and larger than 0.5 microns.
Cleanrooms are classified according to the cleanliness level of the air inside them. The awarded cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air.
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ISO CLASS 5 CLEANROOM
(Fed. Std. 209E rating is Class 100). Has no more than 3.520 particles per cubic meter equal to and larger than 0.5 microns.
The primary authority in the US and Canada is the ISO classification system ISO 14644-1.
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ISO CLASS 6 CLEANROOM
This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room). The most common classes are ISO 7 and ISO 8. The old Federal Standard 209 (class 100,000; 10,000; 1,000; 100; 10; 1) was withdrawn in 2001 and officially replaced by ISO-14644-1 in 1999, but it is still widely used in the controlled environment industry. In addition, cleanrooms must also comply with industry- specific and regional standards. For example, EU GGMP (A-B-C-D) applies to pharmaceutical products and USP (795, 797 and 800) in regard to compounding pharmacies.
(Fed. Std. 209E rating is Class 1.000). Has no more than 35.200 particles per cubic meter equal to and larger than 0.5 microns. ISO CLASS 7 CLEANROOM (Fed. Std. 209E rating is Class 10.000). Has no more than 352.000 particles per cubic meter equal to and larger than 0.5 microns.
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ISO CLASS 8 CLEANROOM
(Fed. Std. 209E rating is Class 100.000). Has no more than 3.520.000 particles per cubic meter equal to and larger than 0.5 microns.
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ISO CLASS 9 CLEANROOM / CNC
Suitable for autoclaving
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