# Cleanroom Classification A cleanroom classification states the maximum permitted airborne particle concentration in a controlled space, defined by ISO 14644-1. It is a supplier attribute medical device and electronics buyers filter on before evaluating anything else. # Cleanroom Classification
A cleanroom classification states the maximum permitted airborne particle concentration in a controlled space, defined by ISO 14644-1. It is a supplier attribute medical device and electronics buyers filter on before evaluating anything else.
**ISO 14644-1 defines classes from ISO 1 to ISO 9**, where a lower number permits fewer particles. ISO 7 and ISO 8 cover most medical device assembly and packaging work; ISO 5 and below belong to pharmaceutical filling and semiconductor processing. **The older Federal Standard 209E numbering is still in common use** and does not map by name. Class 100 corresponds to ISO 5, Class 1,000 to ISO 6, Class 10,000 to ISO 7, and Class 100,000 to ISO 8. A supplier stating one and a buyer reading the other is a routine source of confusion, which is why stating both is worth the extra line. **Classification is a measured state, not a construction specification.** A room is certified by particle counting under defined operating conditions, and the class holds only under those conditions. "At rest" and "in operation" are different measurements, and a claim that omits which one it refers to is incomplete. For medical device work the classification sits alongside the quality system rather than replacing it. ISO 13485 certification qualifies a supplier for medical device manufacturing requests for quote, and a cleanroom is the physical capability that lets a specific class of that work happen at all. For search, this is a high-value attribute stated vaguely almost everywhere. "Cleanroom assembly available" satisfies no filter. **"ISO 7 cleanroom, 2,400 square feet, certified annually" states three matchable facts** and is the kind of statement a constrained supplier prompt can actually match. The same rule holds as for certifications: the scope of what the room is used for, and what is certified, matters more to a buyer than the existence of the room. See [medical device manufacturing](/industries/medical-device) for the wider requirement set, and [ISO 13485](/glossary/iso-13485) for the quality system it accompanies. --- Source: https://manufacturingseo.ai/glossary/cleanroom-classification/ Last reviewed: 2026-08-08 Author: ManufacturingSEO.ai