ISO 14644-1 Class 8 for medical devices

Class 8 to ISO 14644-1 permits up to 3,520,000 particles of 0.5 micrometres and above per cubic metre — the lowest commonly stated cleanroom level. In medical technology it is common wherever particles are to be limited but the product is cleaned and sterilised afterwards: subassembly, packaging of non-critical products, storage of clean components.

That does not make it second best. A well-run class 8 with clear airlock rules, dependable garments and regular monitoring is worth more than a class 7 with the doors propped open. What matters in any case is not the number alone but the operational state it refers to, and qualification to ISO 14644-3 with periodic reverification.

Buyers are therefore better served by the whole picture: how is material transferred in? How often is cleaning carried out, and with what? Is particle concentration measured only at requalification or continuously? And does the level match the product's risk assessment — a higher class than necessary costs money without adding safety.