Back

ISO 14644-1:2015

Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

General information
Valid from 09.12.2015
Directives or regulations
None

Standard history

Status
Date
Type
Name
09.12.2015
Main
ISO 14644-1:2015 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.
ISO 14644-1:2015 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).
ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.
*
*
*
PDF
226.82 € incl tax
Paper
226.82 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + amendment

EVS-EN ISO 11607-1:2020+A11:2022

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Valid from 01.07.2022
Main + amendment

EVS-EN ISO 11607-2:2020+A11:2022

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Valid from 01.07.2022
Main

EVS-EN ISO 10993-10:2023

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Newest version Valid from 01.03.2023
Main

EVS-EN ISO 10993-12:2021

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Newest version Valid from 01.07.2021