BS EN ISO 14644-1:2015
Cleanrooms and associated controlled environments Classification of air cleanliness by particle concentration
Standard number: | BS EN ISO 14644-1:2015 |
Pages: | 48 |
Released: | 2016-01-31 |
ISBN: | 978 0 580 57297 5 |
Status: | Standard |
BS EN ISO 14644-1:2015
This standard BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments is classified in these ICS categories:
- 13.040.35 Cleanrooms and associated controlled environments
This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.
This part of ISO 14644 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm).
This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.
Cleanrooms and associated controlled environments Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)