BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments. Classification of air cleanliness by particle concentration

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BS EN ISO 14644-1:2015

Cleanrooms and associated controlled environments. Classification of air cleanliness by particle concentration

Status : Current   Published : January 2016




These revisions update the 1999 versions of two well-established standards. In so doing, they reflect advances in airborne particle counting science, improve the statistical rigour of cleanliness classifications and update operational monitoring requirements and guidance to improve the practicality and application of the standards.

Who are the standards for?

The audience for these two standards spans different industries and professional disciplines, including:

  • healthcare delivery, including hospitals
  • healthcare research and development
  • healthcare manufacturing, including pharmaceutical and medical devices
  • life sciences research
  • microelectronics and biomedical technology
  • micro-mechanical industries
  • nanotechnology industries
  • optics
  • aerospace.

The standards will be of use to:

-          cleanroom facility users

-          cleanroom testing companies

-          design professionals and consultants

-          facility design and construction professionals

-          vendors of cleanroom technology components, e.g. air filters, safety cabinets, cleaning devices.

What do the standards cover?

These standards are interdependent and relevant in all circumstances where a classified clean environment is required.  

They focus on the definition of air cleanliness by particle number concentration, the trend in this classification procedure, and in Part 2, on requirements and considerations for monitoring clean controlled environments.

The standards are also invoked in regulations such as those found in healthcare industries, e.g. pharmaceutical GMPs and medical devices regulation.

How have the standards changed from the 1999 versions?

The 2015 revisions take into account improved knowledge in the science of airborne particle counting and reconsideration of the levels of statistical confidence that can be practically achieved during cleanroom and clear air device classification.

They introduce some important improvements to the statistical rigour of classification of cleanliness of clean rooms and clean devices and also update requirements and guidance on best practice concerning operational monitoring of such environments.

The main changes concern the process of cleanliness classification, including the method of evaluation of data collected from airborne particle counting. The basic ISO cleanliness classes 1 to 9 do not fundamentally change, but the classification process requires adoption of a revised protocol for every cleanroom or clean air device.

The revised standards also include updated references to normative and supporting standards.

Part 2 has a National Annex that supplements the revised BS EN ISO 14644-2:2015. It gives guidance on maximum time intervals for periodic testing of cleanrooms and clean zones and consists of a table giving information on the suggested maximum time intervals for periodic testing of the performance of cleanrooms or clean zones.

Standard NumberBS EN ISO 14644-1:2015
TitleCleanrooms and associated controlled environments. Classification of air cleanliness by particle concentration
Publication Date31 January 2016
Cross ReferencesISO 14644-2:2015, ISO 14644-7, ISO 21501-4:2007, ASTM F312-08, IEST-G-CC1003, IEST-G-CC1004, JIS B 9920:2002
ReplacesBS EN ISO 14644-1:1999
International RelationshipsEN ISO 14644-1:2015,ISO 14644-1:2015
Draft Superseded By10/30152865 DC
DescriptorsClean rooms, Environmental cleanliness, Classification systems, Particulate air pollutants, Particle size distribution, Designations, Concentration, Conformity, Test equipment, Sample location, Sampling methods, Samples, Outliers, Statistical methods of analysis, Algorithms, Mathematical calculations, Sequential sampling
Title in FrenchSalles propres et environnements maîtrisés apparentés. Classification de la propreté particulaire de l'air
Title in GermanReinräume und zugehörige Reinraumbereiche. Klassifizierung der Luftreinheit anhand der Partikelkonzentration
ISBN978 0 580 57297 5
File Size1.487 MB

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