What is ISO 14644-3 – Cleanroom testing about?
ISO 14644 discusses cleanrooms and associated controlled environments. ISO 14644-3 is the third part of the multi-series on cleanrooms and associated controlled environments, and provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes, and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy, states as-built, at-rest, and operational.
Note: Not all cleanroom parameter test procedures are shown in this document. The procedure and apparatus for the test carried out for the air cleanliness classes by particle concentration and for macroparticles are provided in BS EN ISO 14644-1 and specifications for monitoring air cleanliness by nanoscale particle concentrations are provided in BS EN ISO 14644-12. The procedures and apparatus to characterize other parameters, of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere in other documents, for example, procedures for control and measurement of viable materials (BS EN ISO 14698 series), testing cleanroom functionality (BS EN ISO 14644-4), and testing of separative devices (BS EN ISO 14644-7). In addition, other standards can be considered to be applicable. Other cleanliness attribute levels can be determined using BS EN ISO 14644-8 (levels of air cleanliness by chemicals), BS EN ISO 14644-9 (levels of surface cleanliness by particle concentration) and BS EN ISO 14644-10 (levels of surface cleanliness by chemical concentration).
Who is ISO 14644-3 - Cleanroom testing for?
Industries that benefit from ISO 14644-3 include aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, life sciences, nanotechnology, optics and food.
ISO 14644-3 on cleanroom testing is useful for:
- Professionals involved in cleanroom testing
- Quality assurance and quality control managers
- Cleanroom operations managers
- Cleanroom facility engineers
- Cleanroom project engineers, designers and specifiers
- Cleanroom facility users
- Design professionals and consultants
- Facility design and construction professionals
Why should you use ISO 14644-3 - Cleanroom testing?
Cleanrooms and associated controlled environments provide control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include those in such industries as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, and food.
ISO 14644-3 sets out appropriate test methods for measuring the performance of a cleanroom, a clean zone, or an associated controlled environment, including separative devices and controlled zones, together with all associated structures, air treatment systems, services, and utilities. The test methods, recommended test apparatus, and test procedures for determining performance parameters are provided in ISO 14644-3. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested in ISO 14644-3.
What’s changed since the last update?
BS EN ISO 14644-3:2019 supersedes EN ISO 14644-3:2005.
The main changes compared to the previous version are as follows:
- Clause B.7 has been simplified and corrected to address concerns over its complexity and noted errors
- Guidance concerning classification of air cleanliness by airborne particle concentration has been
- The text of the whole document has been revised or clarified to aid in application
- A segregation test has been introduced
- Other test methods have been updated and expanded
