Cleanroom ISO 14644-1 Standards
The ISO 14644-1 standards were introduced in 1999 due to the need to have a harmonized standard for cleanroom classification and testing. They replaced the US Federal Standard 209E standards. The ISO 14644-1 deals with the classification of air cleanliness in cleanrooms and other controlled environments associated with the cleanroom. The classification is based on the concentration of airborne particulates.
It is applied to a number of industries such as pharmaceutical, healthcare, medical device production, aerospace production, and food production. The ISO 14644-1 Standard is very common in electronics and pharmaceutical production. Internal Standards Organization:
|
Air Cleanliness Class Number |
Maximum Concentration Of Particles Per M³ Of Air |
|||||
0.1 µm |
0.2 µm |
0.3 µm |
0.5 µm |
1 µm |
5 µm |
|
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 |
Source: ispe.org
The classification only considers particle populations with cumulative distributions that meet the lower limit for particle sizes. They usually range from 0.1 µm to 5 µm. Light scattering airborne particle counters (LSAPC) are often used to determine the concentration of airborne particles.
It is important to note that the ISO 14644-1 doesn’t cater to the classification of particle populations that don’t meet the lower threshold for particle size range 0.1 µm to 5 µm. A separate standard is used for concentrations of ultrafine particles that are smaller than 0.1 µm. The ISO 14644-1 is also not used for characterizing chemical, physical, viable, radiological, or any other nature of airborne particles.
The classification only considers particle populations with cumulative distributions that meet the lower limit for particle sizes. They usually range from 0.1 µm to 5 µm. Light scattering airborne particle counters (LSAPC) are often used to determine the concentration of airborne particles.
It is important to note that the ISO 14644-1 doesn’t cater to the classification of particle populations that don’t meet the lower threshold for particle size range 0.1 µm to 5 µm. A separate standard is used for concentrations of ultrafine particles that are smaller than 0.1 µm. The ISO 14644-1 is also not used for characterizing chemical, physical, viable, radiological, or any other nature of airborne particles.
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