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    Cleanroom Classes (ISO 14644)

    ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9).

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 14644-1 defines maximum allowable particle concentrations per cubic meter for each ISO class. Manufacturing of sterile and combination devices typically operates in ISO 7 or ISO 8 backgrounds with ISO 5 critical zones.

    What this means in practice

    Cleanroom classification choices drive HVAC design, gowning, monitoring frequency, and validation scope - early planning errors are expensive to correct.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 14644-1
      Verified
      ISOiso.org
    2. 2
      FDA - Device Manufacturing
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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