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



What is this standard about? 

This is the first part in a two-part series covering the requirements for classified clean environments. It gives guidelines related to air cleanliness, looking specifically at particle concentration.

Who is this standard for?

  • Cleanroom facility users, testers, consultants
  • Vendors of cleanroom technology components such as air filters, safety cabinets
  • Healthcare operators/hospitals/clinics
  • Healthcare design and build/research and development
  • Healthcare manufacturing, including pharmaceutical and medical devices
  • Life sciences research and microelectronics and biomedical technology
  • Micro-mechanical industries
  • Nanotechnology industries
  • Optics
  • Aerospace

Why should you use this standard? 

It focuses on the definition of air cleanliness by particle number concentration and gives the updated classification procedures specified to achieve this. 

This latest revision reflects recent advances in airborne particle counting science and the improved statistical rigour of cleanliness classifications for clean rooms and clean devices.

What’s changed since the last update?

The 2015 revision takes into account improved industry knowledge and a reconsideration of the levels of statistical confidence that can be practically achieved during cleanroom and clear air device classification. Changes include:

  • Amendments to 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

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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