ISO 14644-1:2015 defines how cleanrooms, clean zones, and certain separative devices are classified based on airborne particle concentration within a specified particle-size range.
If you need help matching particle counter capability, sampling approach, and documentation expectations to the ISO class you are targeting, talk with our team about your cleanroom verification workflow.
ISO 14644-1:2015 — Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
ISO 14644-1 is an International Standard used to classify air cleanliness by measuring airborne particle concentrations at defined particle sizes.
It is commonly referenced when a facility needs a documented cleanroom class for manufacturing, packaging, assembly, or R&D operations where particulate contamination control is critical.
Quick Definition
What it is: A classification standard for air cleanliness based on airborne particle concentration.
What it’s used for: Establishing (and communicating) an ISO cleanroom class using particle counter measurements at designated sampling locations.
Key boundary: Classification is based on particle populations with threshold particle sizes from 0.1 µm to 5 µm; it is not intended to characterize particle chemistry, viability, or radiological properties.
What This Standard Covers
ISO 14644-1:2015 covers classification of air cleanliness in cleanrooms and clean zones in terms of the concentration of airborne particles. It also applies to separative devices as defined in ISO 14644-7.
The standard’s classification approach is based on the use of light-scattering (discrete) airborne particle counters to determine particle concentrations (equal to and greater than the specified sizes) at designated sampling locations.
Important limitations: It does not provide for classifying particle populations outside the 0.1 µm to 5 µm threshold size range. It also does not characterize the physical, chemical, radiological, viable, or other nature of particles.
Why This Standard Matters in Testing
ISO 14644-1 is widely used as the “common language” for specifying and verifying particulate air cleanliness. When a customer requirement, internal quality plan, or regulated process calls for a cleanroom class, this standard typically defines how that class is determined and documented.
For labs and facilities teams, it also drives practical decisions such as particle counter sensitivity and channel sizes, sampling logistics, and the format of the evidence package that supports a classification statement.
Common Materials, Product Types, or Applications Covered
ISO 14644-1 is not material-specific. It is used wherever airborne particulate levels can impact product performance, yield, or cleanliness requirements.
Common applications: Semiconductor and electronics manufacturing, pharmaceutical and medical device production, optics and precision assembly, aerospace components, battery manufacturing, and clean packaging/handling areas.
Common Test or Verification Workflow
ISO 14644-1 classification work is typically performed as a cleanroom verification activity (often during qualification, periodic reclassification, or after a significant facility change).
Common workflow:
- Define the cleanroom/clean zone to be classified and the target ISO class required by the user specification.
- Plan particle counter sampling at designated locations within the space (and, when applicable, within separative devices).
- Measure airborne particle concentrations using a light-scattering airborne particle counter at the specified particle-size thresholds used for classification.
- Document results and report the classification outcome in a form suitable for customer, auditor, or internal quality records.
Practical note: Because the standard is classification-focused, the exact sampling plan, reporting expectations, and acceptance criteria details should be taken from the cited edition of the document used in your quality system.
Equipment Commonly Used for This Standard
ISO 14644-1 classification is equipment-driven, but the standard’s requirements generally translate into capability needs rather than one mandated instrument model.
Common equipment: Light-scattering airborne particle counter (LSAPC) with appropriate particle-size channels (within the 0.1 µm to 5 µm threshold range), sampling accessories suitable for repeatable location measurements, and data handling for traceable records.
Selection cautions for quoting: Particle-size capability, flow rate, and how the instrument supports your sampling approach can materially affect practicality and throughput. If you are aligning an instrument package to a specific ISO class target and room size, you can request pricing for a configuration matched to your verification workload.
How to Read This Designation or Revision
ISO 14644-1 identifies Part 1 within the ISO 14644 cleanrooms and associated controlled environments series.
ISO 14644-1:2015 indicates the 2015 edition (Edition 2) of Part 1. ISO identifies this publication as reviewed and confirmed in 2021, meaning it remains current as of that review.
Revision sensitivity: Cleanroom classification statements, documentation language, and sampling expectations can depend on the exact cited edition, so procurement documents and validation protocols should reference the same year/edition being used for testing.
Related Standards, Methods, or Frameworks
ISO 14644-1 is commonly used alongside other parts of the ISO 14644 series when a program needs both classification and ongoing performance evidence, or when separative devices are involved.
Common related references: ISO 14644-2 (monitoring plans for cleanroom/clean zone performance related to particle concentration) and ISO 14644-7 (separative devices).
Get help selecting particle counting and reporting for ISO 14644-1
If you need to align particle counter capabilities, sampling accessories, and documentation output to a specific ISO 14644-1:2015 classification requirement, contact our team to talk through your cleanroom or clean zone setup.