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Cleanroom Specifications

U.S. Federal Standard 209E Cleanroom Standards*

Class Maximum Particles / ft³ ISO
Equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7 3 1   ISO 3
10 350 75 30 10   ISO 4
100   750 300 100   ISO 5
1,000       1,000 7 ISO 6
10,000       10,000 70 ISO 7
100,000       100,000 700 ISO 8

*US FED STD 209E was cancelled by the General Services Administration on November 29, 2001.

IEST ISO 14644-1 International Standard for Cleanrooms more information

Class Maximum Particles / m³ U.S. Federal Standard 209E
Equivalent
≥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   Class 1
ISO 4 10,000 2,370 1,020 352 83   Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1000
ISO 7       352,000 83,200 2,930 Class 10,000
ISO 8       3,520,000 832,000 29,300 Class 100,000

Biosafety Levels

Biosafety levels define the levels of containment required for handling various types of biological hazards. In the United States, there are four levels of containment as specified by the Centers for Disease Control and Prevention (CDC). The table below is based on information provided by in CDC publications.

Containment Level Description
Biosafety Level 1 (BSL-1) Basic level of protection, appropriate for agents that are not known to cause disease in normal, healthy humans.
Biosafety Level 2 (BSL-2) Level of protection appropriate for handling moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure.
Biosafety Level 3 (BSL-3) Level of protection appropriate for agents of indigenous of exotic origin with a know potential for aerosol transmission that may cause serious and potentially lethal infections after inhalation.
Biosafety Level 4 (BSL-4) Highest level of protection, appropriate for exotic agents that pose a high individual risk of life-threatening disease by infectious aerosols and for which no treatment is available.

Related Links

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition Published by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health; Fifth Edition, Feb 2007

European Standard

Grade Air Changes per Hour
Grade A 480-600
Grade B 35-70
Grade C 20
Grade D 20
Controlled Non-Classified N/A


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