ISO 14644-1 Cleanroom Standards
|Class||Maximum Particles/m3||FED STD 209E Equivalent|
|>0.1 um||>0.2 um||>0.3 um||>0.5 um||>1 um||>2 um|
|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||293||Class 100|
|ISO 6||1,000,000||237,000||102,000||35,200||8,320||2,930||Class 1,000|
|ISO 7||352,000||83,200||29,300||Class 10,000|
|ISO 8||3,520,000||832,000||293,000||Class 100,000|
|ISO 9||35,200,000||8,320,000||2,930,000||Room Air|
What is an ISO Cleanroom Rating?
The International Standards Organization creates ISO ratings. It is a worldwide federation of national standards that partners with internal organizations, government agencies, and non-governmental organizations to establish technical performance standards and recommended practices.
What is an ISO 14644-1 Cleanroom Classification?
Achieving an ISO-rated cleanroom environment involves adhering to the ISO 14644-1:2015 standard, which guides designing structures, testing, and calibration. Depending on the task and cleanroom rating, additional features and enclosures may be necessary to ensure isolation, containment, or safe exfiltration of potential hazards, chemicals, aerosols, and particulates. The standard includes requirements for contamination control and risk-mitigating strategies such as health and safety, compatibility with cleaning agents and techniques, cleanability, biocontamination, specific equipment and material needs, and design details.
What Are the ISO Cleanroom Classes for a Cleanroom?
Cleanrooms are categorized based on strict standards that determine their level of cleanliness, known as a “rating.” The rating is assigned between ISO Class 1 and ISO Class 9 based on the number of particles per cubic meter of air. In the US, cleanrooms are usually rated between ISO Class 3 and ISO Class 8, with lower ratings indicating a cleaner environment.
An uncontrolled environment can contain millions or even billions of particles per cubic meter, making it far less clean than a clean room. For example, an ISO 8 cleanroom reduces airborne particulate by a factor of 10 compared to a typical office environment, meaning that each cubic meter of air sampled must contain fewer than 100,000 particles. With each increase in ISO class, air quality improves by a factor of 10.