The 2019 update introduced significant improvements aimed at clarification and simplifying complex procedures:
allows operators to "see" the air. It ensures that airflow is truly unidirectional in critical zones and identifies "dead zones" where contamination might stagnate. Recovery Testing:
ISO 14644-3:2021 specifies the test methods for cleanrooms and associated controlled environments. The standard provides a framework for evaluating the performance of cleanrooms and controlled environments in terms of their ability to control airborne particulate contamination. iso 146443pdf 2021
FS 209E Class 100 is approximately equivalent to ISO Class 5; Class 1,000 to ISO Class 6; Class 10,000 to ISO Class 7; and Class 100,000 to ISO Class 8.
Technicians use an aerosol photometer or a Light Scattering Airborne Particle Counter (LSAPC) to scan the filter face and frame for leaks. The 2019 update introduced significant improvements aimed at
Procedures for actual classification were moved entirely to ISO 14644-1 , leaving Part 3 strictly for supplemental test methods.
While there is no standalone ISO 14644-3:2021 (the standard was majorly revised in and corrected in The standard provides a framework for evaluating the
| Part | Title | Latest Edition | Description | | :--- | :--- | :--- | :--- | | | Classification of air cleanliness by particle concentration | 2015 | Defines ISO cleanroom classes based on airborne particle limits. | | 2 | Monitoring to provide evidence of cleanroom performance | 2015 | Specifies monitoring requirements to prove ongoing compliance. | | 3 | Test methods | 2019 | Describes standardized test methods for cleanroom performance (airflow visualization, particle counting, pressure differentials). | | 4 | Design, construction, and start-up | 2022 | Guidance for creating cleanrooms from requirements through to operation. | | 5 | Operations | 2004 (under revision) | Establishes operational requirements for maintaining specified cleanliness levels. | | 6 | Vocabulary | 2007 (updated 2021) | Consolidated glossary of all terms and definitions used across the series. | | 7 | Separative devices | 2004 (under revision) | Covers clean air hoods, gloveboxes, isolators, and mini-environments. | | 8 | Assessment of air cleanliness by chemical concentration | 2013 (revised 2022) | Provides methods for classifying airborne molecular contamination (AMC). | | 9 | Assessment of surface cleanliness for particle concentration | 2012 (revised 2022) | Establishes procedures for assessing particle cleanliness on solid surfaces. | | 10 | Assessment of surface cleanliness by chemical concentration | 2013 | Addresses chemical contamination on surfaces. | | 12 | Classification of air cleanliness by nanoscale particle concentration | 2018 | Focuses on particles below 0.1 μm (ultrafine and nanoscale particles). | | 13 | Cleaning of surfaces to achieve defined cleanliness levels | 2017 | Provides guidelines for cleaning procedures to meet specific particle and chemical cleanliness standards. | | 14 | Assessment of suitability for use of equipment by airborne particle concentration | 2016 | Specifies methodology for evaluating equipment for cleanroom use. | | 15 | Assessment of suitability for use of equipment and materials by airborne chemical concentration | 2017 | Extends equipment assessment to chemical contamination. | | 16 | Energy efficiency in cleanrooms and separative devices | 2019 | Provides guidance for optimizing energy usage while maintaining cleanliness. | | 17 | Particle deposition rate applications | 2021 (NEW) | Guides interpretation of particle deposition measurements on vulnerable surfaces. | | 18 | Assessment of suitability of consumables | 2023 | Addresses contamination risks from consumables (gloves, wipes, etc.). | | 19 | General technical requirements of modular isolation units for emergency medical use | UNDER DEVELOPMENT | Focuses on emergency medical applications. | | 20 | Microbiological contamination control | UNDER DEVELOPMENT | Addresses viable particle contamination. | | 21 | Airborne particle sampling techniques | 2023 | Technical report providing decision trees for appropriate sampling methods. |
All guidance concerning the classification of air cleanliness by particle concentration was removed from this part and consolidated into ISO 14644-1.
Unlike , which strictly dictates the numerical classification of air cleanliness based on particle concentration, ISO 14644-3 focuses exclusively on the "how-to". It acts as an operational toolkit, defining the precise procedures, instruments, and mathematical criteria needed to prove a cleanroom functions as intended. The Three Cleanroom Occupancy States