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CLEANROOM MANUFACTURING · STANDARDS

What Is an ISO 7 Cleanroom?

An ISO 7 cleanroom is a controlled room that contains no more than 352,000 particles of 0.5 µm or larger per cubic meter of air, as defined by ISO 14644-1. It is equivalent to the former US Class 10,000 and is widely used for electronics assembly, medical device manufacturing and pharmaceutical preparation.

01

The Short Answer

ISO 7 sits in the middle of the cleanroom classes used in manufacturing: ten times cleaner than ISO 8 and ten times less strict than ISO 6. It is the most common class for assembly work where particles matter but the product is not exposed as a sterile open process.

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    0.5 µm and larger No more than 352,000 particles per m³.
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    1 µm and larger No more than 83,200 particles per m³.
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    5 µm and larger No more than 2,930 particles per m³.
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    Former US class Class 10,000 under FS 209E.
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    EU GMP Grade C at rest; Grade B in operation.
02

Where ISO 7 Cleanrooms Are Used

ISO 7 rooms are used for electronics and PCB assembly, medical device manufacturing and packaging, pharmacy compounding and as the background room around ISO 5 zones in pharmaceutical production. Air is HEPA filtered and the room is held at a positive pressure over its surroundings.

03

Computers in an ISO 7 Cleanroom

Equipment in an ISO 7 room should add no particles and survive daily disinfection. That usually means a fanless panel PC or display with no vents, a sealed front of at least IP65 and surfaces that can be wiped with alcohol. Our guide to clean room computers covers the features to specify.