Cleanroom Standards Guide
Introduction
Clean rooms and other critical environments are classified based on their level of airborne contamination, as defined by the ISO 14644-1 standard. This standard has replaced the older US Federal Standard 209E and provides a comprehensive framework for measuring and reporting air cleanliness by counting particles of different sizes in a cubic meter of air.
Note: The higher the number of particles, the dirtier the room. (ISO 1 most stringent -> ISO 9 least stringent)
The table below outlines the different classes of clean rooms, the number of particles per cubic meter by micrometer size and typical uses for each ISO class. This classification helps ensure that facilities meet the necessary cleanliness standards to protect sensitive equipment and processes.
Cleanroom Classification
Class | Particulate Count/m³ by Particle Size(μm) | Typical Use | |||
0.1 μmparticles | 0.5 μm particles | 1 μm particles | 5 μm particles | ||
ISO 9 | NA | 3,52,00,000 | 83,20,000 | 2,93,000 | General Manufacturing, General Quality Control Laboratories,Consumer Electronics Production |
ISO 8 | NA | 35,20,000 | 8,32,000 | 29,300 | Computer rooms |
ISO 7 | NA | 3,52,000 | 83,200 | 2930 | Hospital operating rooms, some factories |
ISO 6 | 10,00,000 | 35,200 | 8,320 | 293 | Manufacturing computer disk drives, sensitive materials |
ISO 5 | 1,00,000 | 3,520 | 832 | 29 | High-purity fi ne chemicals for industrial use and research, ion lithium batteries for electric vehicles, solar panel manufacturing, active medical devices |
ISO 4 | 10,000 | 352 | 83 | NA | LED Manufacturing, High-precision Machining, Satellite Assembly,Photolithography, High-purity Chemical Synthesis |
ISO 3 | 1,000 | 35 | 8 | NA | Optical Fiber Production, Laser Assembly, Aerospace Component Manufacturing, Medical Implants, Production of storage devices like SSDs. |
ISO 2 | 100 | 4 | NA | NA | Microelectronics Fabrication, Production of highly sensitive medical implants, Manufacturing of sterile pharmaceutical products with high sensitivity, Advanced Biotechnology Research, Precision Metrology |
ISO 1 | 10 | NA | NA | NA | Advanced Semiconductor Manufacturing, Aerospace Instrument Assembly, Ultra-precision Optics. Nanotechnology Fabrication, Genetic Research |