BS EN ISO 14644-2:2015 Cleanrooms and associated controlled environments. Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

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BS EN ISO 14644-2:2015

Cleanrooms and associated controlled environments. Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

Status : Current   Published : January 2016

Format
PDF

Format
HARDCOPY



What is this standard about? 

This is the second part in a two-part series covering requirements for the monitoring of air cleanliness in classified clean environments.

Who is this standard for?

  • Cleanroom facility users, testers, consultants
  • Healthcare facilities design and build teams
  • Vendors of cleanroom technology components such as air filters, safety cabinets
  • Healthcare operators/hospitals/clinics
  • Healthcare 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?

ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.

The latest revisions reflect advances in airborne particle counting science and improve the statistical rigour of cleanliness classifications. This part also introduces some important improvements to the statistical rigour of classification of cleanliness of clean rooms and clean devices and update requirements and guidance on best practice concerning operational monitoring of such environments.

What’s changed since the last update?

  • Part 2 now 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
  • 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 standard also includes updated references to normative and supporting standards



Standard NumberBS EN ISO 14644-2:2015
TitleCleanrooms and associated controlled environments. Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
StatusCurrent
Publication Date31 January 2016
Cross ReferencesISO 14644-1:2015, ISO 14644-4:2001, ISO 14644-12, ISO 14644-3, ISO 21501-4:2007, ISO 31000:2009
ReplacesBS EN ISO 14644-2:2000
International RelationshipsEN ISO 14644-2:2015,ISO 14644-2:2015
Draft Superseded By10/30152881 DC
DescriptorsClean rooms, Environmental cleanliness, Air cleaning equipment, Decontamination, Conformity, Classification systems
ICS13.040.35
Title in FrenchSalles propres et environnements maîtrisés apparentés. Surveillance du maintien des performances de la salle propre pour la propreté particulaire de l'air
Title in GermanReinräume und zugehörige Reinraumbereiche. Überwachung zum Nachweis der Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration
CommitteeLBI/30
ISBN978 0 580 57301 9
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size1.168 MB
Price£170.00


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