ISO 14644-1:2015
ISO 14644-1 requirements for classifying cleanroom air cleanliness by particle concentration: occupancy states, considered particle sizes, the ISO Class designation, verification by the reference method with calibrated counters, evaluation of every sampling location against the class limits, the test report, and the normative method for sampling locations, sample volumes, sampling procedure, result processing and out-of-specification investigation.
ISO 14644-1:2015 is a compliance framework from International with 3 domains and 16 controls. The largest domains are Annex A (normative): Reference method for classification by particle concentration – ISO 14644-1:2015 (7 controls), Clause 4: Classification – ISO 14644-1:2015 (5 controls), Clause 5: Demonstration of compliance – ISO 14644-1:2015 (4 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (3)
Annex A (normative): Reference method for classification by particle concentration – ISO 14644-1:2015
| Code | Title |
|---|---|
| iso-14644-1-2015::A.2 | Use a discrete particle counter able to size and count at the required sizes, with a valid calibration |
| iso-14644-1-2015::A.3 | Confirm the cleanroom is complete and functioning to specification before counting |
| iso-14644-1-2015::A.4.1-3 | Derive the minimum number of sampling locations and position them representatively |
| iso-14644-1-2015::A.4.4 | Set the single sample volume and time per location from the class limit, at least 2 litres and 1 minute |
| iso-14644-1-2015::A.5 | Follow the sampling procedure: set-up and zero check, probe orientation, occupancy conditions, handling of abnormal counts |
| iso-14644-1-2015::A.6.1 | Record each sample count and calculate the average and the concentration per cubic metre at each location |
| iso-14644-1-2015::A.6.2 | Judge classification from the per-location averages and investigate any out-of-specification result |
Clause 4: Classification – ISO 14644-1:2015
| Code | Title |
|---|---|
| iso-14644-1-2015::4.1 | Define the class for one or more occupancy states |
| iso-14644-1-2015::4.2 | Choose the threshold particle size or sizes within the permitted range |
| iso-14644-1-2015::4.3 | Designate the class by its ISO Class number using the limit table |
| iso-14644-1-2015::4.4 | State the full designation: class, occupancy state and considered sizes, with a size ratio of at least 1,5 |
| iso-14644-1-2015::4.5 | Use Annex E for intermediate decimal classes and intermediate size thresholds |
Clause 5: Demonstration of compliance – ISO 14644-1:2015
| Code | Title |
|---|---|
| iso-14644-1-2015::5.1 | Verify compliance by specified testing and documentation, repeat by risk, and monitor under ISO 14644-2 |
| iso-14644-1-2015::5.2 | Test by the Annex A reference method, or an agreed equivalent, with calibrated instruments |
| iso-14644-1-2015::5.3 | Evaluate particle concentrations against the class limits at every location, by one method for all sizes |
| iso-14644-1-2015::5.4 | Issue a comprehensive test report with a compliance statement and the required contents |
What is ISO 14644-1:2015 and who does it apply to?
ISO 14644-1:2015 is a compliance framework from International with 3 domains and 16 controls. ISO 14644-1 requirements for classifying cleanroom air cleanliness by particle concentration: occupancy states, considered particle sizes, the ISO Class designation, verification by the reference method with calibrated counters, evaluation of every sampling location against the class limits, the test report, and the normative method for sampling locations, sample volumes, sampling procedure, result processing and out-of-specification investigation. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ISO 14644-1:2015 actually require?
ISO 14644-1:2015 has 16 controls organised across 3 domains. The largest domains are Annex A (normative): Reference method for classification by particle concentration – ISO 14644-1:2015 (7 controls), Clause 4: Classification – ISO 14644-1:2015 (5 controls), Clause 5: Demonstration of compliance – ISO 14644-1:2015 (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ISO 14644-1:2015 do I already cover?
ISO 14644-1:2015 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement ISO 14644-1:2015?
Start your ISO 14644-1:2015 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 14644-1:2015 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 16 controls and track your progress.
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