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ISO 14644-1 classifies cleanroom air cleanliness by the maximum allowable concentration of airborne particles. The classification, from ISO 1 to ISO 9, is determined by the formula [latex]C_N = 10^N \times (\frac{0.1}{D})^{2.08}[/latex], where [latex]C_N[/latex] is the max concentration of particles/m³, N is the ISO class number, and D is the particle size in µm.
The ISO 14644-1 standard provides a globally recognized framework for specifying the cleanliness of air in cleanrooms and controlled environments. It replaced the widely used US Federal Standard 209E, which classified rooms as Class 100, Class 10,000, etc., based on particle counts per cubic foot. The ISO formula, [latex]C_N = 10^N \times (\frac{0.1}{D})^{2.08}[/latex], establishes a logarithmic relationship between the ISO class number (N) and the maximum permitted particle concentration ([latex]C_N[/latex]) for a given particle size (D). For example, an ISO 5级 cleanroom must not exceed 3,520 particles/m³ at a size of 0.5 µm and 293 particles/m³ at 1.0 µm. This is roughly equivalent to the old FED STD 209E Class 100.
Certification to an ISO class requires rigorous testing procedures. Particle counters are used at multiple, statistically determined locations within the room to measure airborne particulate levels. The room must meet the concentration limits for all specified particle sizes to achieve its classification. The standard also outlines requirements for monitoring to maintain performance over time. This systematic approach ensures that a cleanroom in one part of the world is directly comparable to another, which is critical for global supply chains in high-tech industries like microelectronics and pharmaceuticals where microscopic contaminants can cause catastrophic product failure.
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