Project Description

ISO 14644-1 Standard for Clean Rooms

Clean Rooms

One of the most important requirements in ISO 14644-1 for clean rooms is the maximum concentration limits of particles.

Particle Diameter (μm) >= 0.1 >= 0.2 >= 0.3 >= 0.5 >= 1 >= 5
ISO Class 8 (pc/cubic meters) – – – – – – – – – 3,520,000 832,000 29,300

Note: They are equivalent to the requirements for Class 100,000 in the obsolete Federal Standard 209.

There is an advice by an external party that High Efficiency Penetration Air (HEPA) Filtration of 99.99% efficient at 0.3 micron may be considered to achieve ISO Class 8.

For the clean room tests against ISO 14644-1:2015, the primary tests normally include:

  • airborne particle count for cleanliness classification test,
  • room pressurization / differential test,
  • airflow capacity and air exchange rate,
  • HEPA filter leak test, and
  • viable airborne biocontamination test.


Typically, the test service for clean rooms is provided by a testing lab. At present, DQS HK is NOT providing testing or certification service against ISO 14644.


Above information is for reference only and may not be up-to-date when you read it, which is not intended to be used for your decision making.


ISO 13485 Certification
CE Marking


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