KRINKO/BfArM-compliant documentation creates Vermutungswirkung under MPBetreibV §8(2) — your reprocessing is legally presumed proper. SecuSteri replaces paper batch records with a tamper-proof digital archive.
"Before SecuSteri, I spent 20 minutes every evening filling in the sterilization logbook. Now the Castellini report shows up on its own, I add the instruments, I sign with my PIN — a few minutes per load."
The Medizinprodukte-Betreiberverordnung (MPBetreibV, revised February 2025) mandates documented reprocessing procedures for all medical devices. §8(2) creates a Vermutungswirkung — a legal presumption that your reprocessing is proper when you follow the KRINKO/BfArM Recommendation 2012. This recommendation requires batch documentation (Chargendokumentation), daily Bowie-Dick/Helix tests, regular biological controls, and instrument risk classification (Unkritisch through Kritisch B). Records must be retained for 5 years. The Gesundheitsamt conducts announced and unannounced inspections.
MPBetreibV (2025), §§5, 8, 12-13 · KRINKO/BfArM Empfehlung 2012 · DIN EN 13060 · DIN EN ISO 15883 · DAHZ Hygieneleitfaden 2024
Regulatory guides to help you understand your obligations.
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 report — SecuSteri extracts the cycle data automatically. Currently supports MELAG, W&H, Castellini, Anthos, Mocom and more, with new 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.
These instruments come pre-loaded when you create your account. You can add, edit, or remove instruments at any time.
Reports from MELAG, W&H, Castellini, Anthos, Mocom and more are imported automatically via AutoReport or manual upload. Other brands? Upload the report or enter cycle data manually — we add automatic support progressively.
Verify every compliance point before the inspector arrives. Download the PDF instantly — no email required.
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