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Purification level

Views: 0     Author: Site Editor     Publish Time: 2021-11-26      Origin: Site

In 1963, the United States had a clean room federal standard Fed STD 209. In 209 standards, the clean room is divided into several levels per cubic feet in the environment, such as level 100, 10,000, 100,000. China's past cleansing room standards are also graded in this way. In 1999, the International Standardization ISO promulgated clean room international standard ISO14644-1 \"clean room and controlled clean environment, primary part: air cleanliness classification\".

In 1999, the International Standardization ISO promulgated clean room international standard ISO14644-1 \"clean room and controlled clean environment, primary part: air cleanliness classification\". The ISO specified in the cleanliness level and the specific numerical value of traditional grading are shown in the table below.

ISO14644Concentration limit (number of particles / M3)Approximate
Grade0.1mm0.2mm0.3mm0.5mm1.0mm5.0mmTraditional specifications
ISO level 1102




ISO level 210024104


ISO level 31,000237102358
Level 1
ISO level 410,0002,3701,02035283
Level 10
ISO level 5100,00023,70010,2003,52083229Level 100
ISO 6 level1,000,000237,000102,00035,2008,320293Level 1,000
ISO 7 level


352,00083,2002,93010,000
ISO 8


3,520,000832,00029,300100,000
ISO level 9


35,200,0008,320,000293,000

The above indicators are expressed by formulas:

CN = 10N3 (0.1 / d) 2.08

Where: CN = Variety per cubic meter allows for a number of particle size particles;

N = ISO cleanliness division number;

D = Particle size, unit is micron;

0.1 = constant, the unit is micron.

The ISO grading was adopted in the new revised draft of China's clean room. However, people have been used to \"百 \ \", \"10,000 level \", it is obvious, easy to book, people may take the old, until the new generation designers don't remember the old classification And British Metrology Unit.

Safe, cleanliness, should correspond to the status of clean room: empty state (new, empty room), static (equipment in place, no person), dynamic (normal work). Specific project said that \"clean degree \" refers to which state, and is determined by the user and design, supply, etc. agreement and clearly. Forgot to make regulations in the state, everyone will have a empty drill.

Attached: cleanliness of GMP

Clean levelDust numberMicroorganism allowsEquivalent
≥0.5mm≥5mmFloating bacteria / M3Substate / dishISO grading
Level 1003,500051ISO level 5
10,000350,0002,0001003ISO 7 level
100,0003,500,00020,00050010ISO 8
300,00010,000,00060,000
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