Sterilization traceability for dental practices in Italy

Italy's Legge Gelli makes documented adherence to published guidelines a direct legal defense. SecuSteri replaces your paper logbook with an always-accessible cloud archive aligned with ISPESL guidelines and UNI/TR 11408.

What the law requires from dental practices

ASL · D.Lgs 81/2008 · ISPESL Linee Guida · Legge Gelli

Italian dental practices are classified as healthcare facilities under D.Lgs 81/2008 Title X (Art. 274). The practice owner (titolare dello studio), as the legal employer, is responsible for implementing the sterilization process and its documentation. The 2010 ISPESL Linee Guida and UNI/TR 11408:2011 define the full reprocessing chain (decontamination → washing → drying → inspection → packaging → sterilization → storage → traceability) and require record archival for 5–10 years depending on regional directive. UNI EN 13060 makes Class B autoclaves mandatory for hollow instruments (turbines, handpieces). The Legge Gelli-Bianco (Law 24/2017) introduces criminal liability (Art. 590-sexies of the Criminal Code) and civil liability for professional negligence: non-punishability is granted ONLY when published guidelines were followed and documented. Article 4 of the same law requires healthcare facilities to make clinical documentation available within 7 days of patient request. The ASL conducts announced and unannounced inspections and can order practice closure for serious violations.

D.Lgs 81/2008, Title X (Art. 266-286, in particular Art. 274) · ISPESL Linee Guida May 2010 · UNI/TR 11408:2011 · UNI EN 13060 (Class B) · UNI EN 556-1 (SAL 10⁻⁶) · UNI EN ISO 17665-1 · Law 24/2017 (Gelli-Bianco), Art. 4, 5, 6, 7

How SecuSteri helps

Instrument-level traceability

Go beyond simple cycle logging. Track which specific instruments were in each autoclave load and link them to patient records via QR-coded labels.

Automatic report import

Upload your autoclave's PDF report — SecuSteri extracts the cycle data automatically. Currently supports W&H Lisa, Castellini, and Anthos with more brands added regularly.

Multi-user for group practices

Invite your dental assistants as team members. Each person signs cycles with their own PIN — individual accountability in a shared practice.

Always ready for inspection

Every signed cycle is tamper-proof and instantly accessible. Present your complete sterilization history on a tablet during any inspection.

Pre-loaded instruments for dental practices

Dental mirrors Explorers Excavators Syndesmotomes Elevators Extraction forceps Scalers

These instruments come pre-loaded when you create your account. You can add, edit, or remove instruments at any time.

Works with all autoclave brands

W&H Lisa Melag Euronda Castellini Anthos Tuttnauer

W&H, Castellini, and Anthos reports are imported automatically via AutoReport or manual upload. Other brands? Upload the report or enter cycle data manually — we add automatic support progressively.

Free Inspection Checklist

Verify every compliance point before the inspector arrives. Download the PDF instantly — no email required.

Get your dental practice inspection-ready

30 days free. No credit card required. Set up in under 5 minutes.