The UNI EN ISO 14644-1 standard explained in brief

The UNI EN ISO 14644-1 standard was developed with the aim of regulating the production of clean rooms and associated controlled environments. It belongs to the broader UNI EN ISO 14644 regulation related to the sector and specifically addresses the classification of air cleanliness by defining cleanliness classes (ISO 1-9) and their corresponding maximum allowable particle content, replacing the previous Federal Standard 209. Compliance is not a legal obligation, but it serves as a reference that anyone interested in purchasing a clean room considers during negotiations. Let’s review the fundamental principles it contains.

UNI EN ISO 14644-1 Regulation: Maximum Particle Content Levels
The first and essential definition in the standard specifies the maximum numerical values of particles measuring 0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 1 µm, and 5 µm per cubic meter of air required to classify a clean room into ISO cleanliness classes 1 to 9. These are the specified values:

– ISO 1: 10 particles 0.1 µm, 2 particles 0.2 µm;
– ISO 2: 100 particles 0.1 µm, 24 particles 0.2 µm; 10 particles 0.3 µm, 4 particles 0.5 µm;
– ISO 3: 1000 particles 0.1 µm, 237 particles 0.2 µm; 102 particles 0.3 µm, 35 particles 0.5 µm, 8 particles 1 µm;
– ISO 4: 10,000 particles 0.1 µm, 2370 particles 0.2 µm; 1020 particles 0.3 µm, 352 particles 0.5 µm, 83 particles 1 µm;
– ISO 5: 100,000 particles 0.1 µm, 23,700 particles 0.2 µm; 10,200 particles 0.3 µm, 3520 particles 0.5 µm, 832 particles 1 µm, 29 particles 5 µm;
– ISO 6: 1,000,000 particles 0.1 µm, 237,000 particles 0.2 µm; 102,000 particles 0.3 µm, 35,200 particles 0.5 µm, 8320 particles 1 µm, 293 particles 5 µm;
– ISO 7: 352,000 particles 0.5 µm, 83,200 particles 1 µm, 2930 particles 5 µm;
– ISO 8: 3,520,000 particles 0.5 µm, 832,000 particles 1 µm, 29,300 particles 5 µm;
– ISO 9: 35,200,000 particles 0.5 µm, 8,320,000 particles 1 µm, 293,000 particles 5 µm.

Other Points of the UNI EN ISO 14644-1 Regulation
The standard also includes the definition of three states of occupancy of the clean room at the time of measurement. These are ‘at built’ (measurements should be taken in the finished facility but still without machinery and personnel), ‘at rest’ (measurements should be taken with machines operating but without personnel), and ‘in operation’ (measurements should be taken with machines and personnel present and normally active). Guidelines are also provided on how to take measurements of values from samples within clean room validation practices.

You can request more information about the UNI EN ISO 14644-1 standard or our clean room projects by contacting Phamm Engineering now.

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