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
