ISO 13485 doesn’t mandate a cleanroom. But for any device with a sterile or implantable claim, you need one — and the standard’s expectations on environmental controls bite hard during audits.
Class 8 baseline (ISO 14644)
- ≤3,520,000 particles ≥0.5μm per cubic meter
- HEPA filtration at the air inlet
- Positive pressure (10–15 Pa above adjacent space)
- Logged temperature 18–24°C, humidity 30–60% RH
What actually fails audits
The cleanroom itself rarely fails. The gowning room does. The pass-through does. The records do.
- Operators leaving the room without re-gowning on return
- Particle counts logged daily but reviewed quarterly (the standard expects review at the frequency of logging)
- Incoming material wiped down with the wrong solvent for the surface
- Cleaning logs that show “complete” without identifying the operator
The cleanroom is just a room. The discipline is the product.