Latest 2026 Update on ISO 14644 and TCVN 8664 Standards
14:58 - 04/03/2026 222
What Is a VAV System? Structure, Operating Principle, and Applications in HVAC
The Future of Robotics and Automation Technology in Cleanroom Cleaning Processes
EN 1822 Standard: Classification and Evaluation of the Latest HEPA H13, H14, and ULPA Filters
Sterile Material Transfer Systems for Isolators/RABS.
Latest Update on ISO 14644 and TCVN 8664 Standards in 2026
ISO 14644-1 is the standard used to classify air cleanliness in cleanrooms and associated controlled environments based on the concentration of airborne particles. In Vietnam, TCVN 8664-1:2011 is commonly referenced in documentation under the TCVN system and is noted as being equivalent to ISO 14644-1:1999.
1. Current ISO 14644-1 Standard
The current version of ISO 14644-1 that is widely used is ISO 14644-1:2015, which replaced ISO 14644-1:1999. This standard serves as the basis for the design, evaluation, and operation of cleanrooms in industries that require particulate contamination control.

2. Contents of ISO 14644-1:2015
2.1. Scope of Application
ISO 14644-1:2015 specifies the method for classifying air cleanliness by particle count for cleanrooms and clean zones. Classification may be carried out under one or more occupancy states such as as-built, at-rest, and operational, depending on the agreed project conditions. Particle sizes used for classification range from ≥0.1 µm to ≥5.0 µm.
2.2. Classification System (ISO Classes)
ISO 14644-1:2015 uses the ISO Class system and maximum particle concentration limits for each particle size threshold, expressed in particles/m³. In the standard’s limit table, the symbol “—/–” indicates that measurement is not required for that particle size.
The table below extracts several commonly used reference points in QA/QC for quick review and does not replace the full table in the standard:

(In actual qualification or acceptance work, you still need to clearly define which particle sizes are being considered according to the URS/specification and apply the corresponding limit values.)
2.3. Sampling and Evaluation Method
Regarding the number of sampling points, the standard provides guidance for determining the minimum number of sampling locations based on the area of the cleanroom or clean zone, and for areas greater than 1,000 m², a formula in Annex A is used with rounding up to the nearest whole number. The arrangement of sampling points is described by dividing the area into sections corresponding to the number of locations and selecting representative positions, with additional points allowed at critical locations.
Regarding sample volume, the standard requires that sufficient air volume be collected at each location to expect a minimum count of 20 particles if the concentration is exactly at the ISO Class limit being evaluated. The standard also includes constraints such as a minimum sample volume of 2 liters at each location, a minimum sampling time of 1 minute for each sample, and the use of the same single sample volume at all locations.
The pass/fail criterion is described such that a cleanroom or clean zone passes if the average particle concentration value at each location, converted to particles/m³, does not exceed the corresponding class limit in the classification table.
2.4. Test Report
A test report should normally include at least the following: information about the testing organization and the test date, the applied standard (ISO 14644-1:2015), a description of the cleanroom or clean zone and the positions or coordinates of the sampling points, the specified criteria (ISO Class, occupancy state, and particle sizes considered), a description of the method and any conditions or exceptions, information about the measuring equipment and calibration status, and the result data for all sampling points.
3. Is ISO 14644-1 Applied in Vietnam?
ISO 14644-1 is applied in Vietnam through the national standards system, under which Vietnam has issued TCVN 8664-1:2011 based on ISO 14644-1:1999. In actual project practice, many facilities still directly apply ISO 14644-1:2015 to meet the technical requirements of investors, partners, or high-specification industries.
![]() | ANH KHANG CLEANROOM M&E JOINT STOCK COMPANY Hotline: 1900 636 814 - 0902 051 222 Email: info@akme.com.vn Website: akme.com.vn Address: Lot B7 - Xuan Phuong Garden - Trinh Van Bo Street - Xuan Phuong Ward - Hanoi |
12:05 - 28/11/2019 48238
Cleanroom Design and Construction
14:05 - 11/03/2025 23665
GMP and ISO Standard Cleanroom Construction
14:18 - 11/03/2025 12616
ISO Standard Medical Cleanroom Construction
14:13 - 28/02/2025 23940
Electronics Cleanroom Construction
16:15 - 18/03/2021 6740
Warranty Service
16:26 - 28/11/2019 19623
Supply and installation of cleanroom equipment
14:50 - 26/11/2019 6464
Technology Production Line Consulting
16:35 - 19/03/2025 20175


