BS EN ISO 14644-1:2015

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