National Regulations
The clean room originated from the United States Federal Standard Fed-Std-209E in the 1960s, and has since become more popular and widely accepted by the semiconductor industry and the pharmaceutical industry. In the late 1990s, in response to the trend of globalization, ISO-14644 came into being. With the increasing development of industry, Europe and Japan also have their own standards, but the international mainstream is still “ISO-14644-1” and the United States “Fed-Std-209E”. Here are the following:
ISO-14644-1
| The maximum allowable amount of particles equal to or larger than the following diameter per cubic meter | ||||||
| Level | 0.1μm | 0.2μm | 0.3μm | 0.5μm | 1.0μm | 5.0μm |
| ISO Class 1 | 10 | 2 | — | — | — | — |
| ISO Class 2 | 100 | 24 | 10 | 4 | — | — |
| ISO Class 3 | 1,000 | 237 | 102 | 35 | 8 | — |
| ISO Class 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | — |
| ISO Class 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO Class 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| ISO Class 7 | — | — | — | 352,000 | 83,200 | 2,930 |
| ISO Class 8 | — | — | — | 3,520,000 | 832,000 | 29,300 |
| ISO Class 9 | — | — | — | 35,200,000 | 8,320,000 | 293,000 |
| NOTE Uncertainties related to the measurement process requires that concentration data with no more then three significant figures be used in determining the classification level. Equation (1): Cn = 10N X (0.1/D)2.08 Cn is particle concentration, N is cleanliness, D is particle size | ||||||
US Federal Standard 209E
| Industrial clean room Cleanliness | Particle size of dust particles | ||||||||||
| 0.1μm | 0.2μm | 0.3μm | 0.5μm | 0.5μm | |||||||
| Cumulative particle number | Cumulative particle number | Cumulative particle number | Cumulative particle number | Cumulative particle number | |||||||
| SI | Class | (m3) | (ft3) | (m3) | (ft3) | (m3) | (ft3) | (m3) | (ft3) | (m3) | (ft3) |
| M1 | 350 | 9.91 | 75.7 | 2.14 | 30.9 | 0.875 | 10.0 | 0.283 | – | – | |
| M1.5 | 1 | 1240 | 35.0 | 265 | 7.50 | 106 | 3.00 | 35.3 | 1.00 | – | – |
| M2 | 3,500 | 99.1 | 757 | 21.4 | 309 | 8.75 | 100 | 2.83 | – | – | |
| M2.5 | 10 | 12,400 | 350 | 2,650 | 75.0 | 1,060 | 30.0 | 353 | 10.0 | – | – |
| M3 | 35,000 | 991 | 7,570 | 214 | 3,090 | 87.5 | 1,000 | 28.3 | – | – | |
| M3.5 | 100 | – | – | 26,500 | 750 | 10.600 | 300 | 3,530 | 100 | – | – |
| M4 | – | – | 75,700 | 2,140 | 30,900 | 875 | 10,000 | 283 | – | – | |
| M4.5 | 1000 | – | – | – | – | – | – | 35,300 | 1,000 | 247 | 7.00 |
| M5 | – | – | – | – | – | – | 100,000 | 2,830 | 618 | 17.5 | |
| M5.5 | 10,000 | – | – | – | – | – | – | 353,000 | 10,000 | 2,470 | 70.0 |
| M6 | – | – | – | – | – | – | 1,000,000 | 28,300 | 6,180 | 175 | |
| M6.5 | 100,000 | – | – | – | – | – | – | 3,530,000 | 100,00 | 24,700 | 700 |
| M7 | – | – | – | – | – | – | 10,000,000 | 283,000 | 61,800 | 1,750 | |
Japanese standard JIS B 9920
| Each cubic meter is equal to or larger than the following grains Maximum allowable amount of particles in diameter | |||||
| 0.1μm | 0.2μm | 0.3μm | 0.5μm | 1μm | 05μm |
| 10 | 2 | — | — | — | — |
| 100 | 24 | 10 | 4 | — | — |
| 1,000 | 237 | 102 | 35 | 8 | — |
| 10,000 | 2,370 | 1,020 | 352 | 83 | — |
| 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| — | — | — | 352,000 | 83,200 | 2,930 |
| — | — | — | 3,520,000 | 832,000 | 29,300 |
| — | — | — | 35,200,000 | 8,320,000 | 293,000 |
British Standard BS 5295
| Level< /td> | Each cubic meter is equal to or larger than the following Maximum allowable amount of particles in diameter | ||||
| 0.5μm | 1μm | 5μm | 10μm | 25μm | |
| Class 1 | 3,000 | — | 0 | 0 | 0 |
| Class 2 | 300,000 | — | 2,000 | 30 | — |
| Class 3 | — | 1,000,000 | 20,000 | 4,000 | 300 |
| Class 4 | — | — | 200,000 | 40,000 | 4,000 |
Comparison of the world's major clean room levels
| International standards | Dust-free level | |||||
| ISO 14644-1 | ISO 3 | ISO 4 | ISO 5 | ISO 6 | ISO 7 | ISO 8 |
| United StatesFS 209E | Class 1 | Class 10 | Class 100 | Class 1000 | Class 10000 | Class 100000 |
| United KingdomBS 5295 | C | D | E/F | G/H | J | K |
| Germany VD I.2083 | 1C | 2 | 3 | 4 | 5 | 6 |
| Australia AS 1386 | 0.035 | 0.35 | 3.5 | 35 | 350 | 3500 |
| FranceNOR X44101 | — | — | 4000 | — | 4,000 | 4,000,000 |
| Grade (Drug clean area grade) | – | A/B | – | C | D | |