A written, accessible, up-to-date sterilization protocol is the first line of defense during an Inspection sanitaire inspection. In Luxembourg, the general professional duty of hygiene (Loi modifiée du 29 avril 1983), the Loi modifiée du 16 janvier 1990 on medical devices, and Regulation (EU) 2017/745 require every practice to maintain documented procedures for the sterilization of reusable medical devices. The Collège médical may impose disciplinary measures in case of professional misconduct. This guide details the content of a compliant protocol and the documentation expected.
Every dental practice in Luxembourg should have a written sterilization protocol, accessible to all staff and available during inspections. No LU-specific règlement grand-ducal on dental sterilization exists: the framework rests on the general professional duty of hygiene (Loi modifiée du 29 avril 1983), the Loi modifiée du 16 janvier 1990 on medical devices, and Regulation (EU) 2017/745 (MDR) directly applicable. A documented protocol covering the entire sterilization chain is expected by European sector best practice and may be verified at any time by the Inspection sanitaire (Direction de la santé).
The designated person responsible for sterilization within the practice. A detailed description of each step in the sterilization chain (pre-disinfection, cleaning, rinsing, drying, packaging, autoclaving, storage). The maintenance and validation schedule for the autoclave (initial qualification, annual requalification, preventive maintenance). The frequency of biological and physico-chemical controls. The traceability method used (paper or digital register). Waste management procedures (Loi modifiée du 21 mars 2012 on waste). The staff continuing education plan.
For the step-by-step sterilization chain, see our dental sterilization chain guide.
A cycle is valid when the recorded parameters match the selected program and all indicators are compliant. In dental practice, the reference cycle is 134°C for 18 minutes (prion cycle). European sector best practice and Regulation (EU) 2017/745 recommend a Class B autoclave (NF EN 13060) for sterilizing hollow instruments (handpieces, contra-angles) and wrapped loads. Thermal validation aligns with EN ISO 17665-1.
Before the first load of each working day, a Bowie-Dick test (pre-vacuum autoclaves) or Helix test (hollow instruments) validates the autoclave's proper functioning. A failed cycle or non-compliant indicator requires repackaging and re-sterilizing the entire load.
For details on biological controls, see our autoclave biological controls guide.
In the absence of a specific règlement grand-ducal on dental sterilization, the reference framework for inspections rests on four pillars: the general professional duty of hygiene (Loi modifiée du 29 avril 1983), the Loi modifiée du 16 janvier 1990 on medical devices, Regulation (EU) 2017/745 (MDR) directly applicable, and adopted European standards (NF EN 13060, EN ISO 17665-1, EN ISO 15883, NF EN 14476). The Inspection sanitaire (Direction de la santé) is the inspecting authority; the Collège médical is the disciplinary authority.
The most commonly flagged issues during inspections: missing instrument-to-patient traceability, absent or incomplete written protocol, undocumented biological controls. In case of professional misconduct, the Collège médical may impose disciplinary sanctions and the Ministre de la Santé may suspend the authorization to practice.
The protocol must define the traceability method used. Paper registers remain acceptable, but their limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-patient link, risk of loss in case of disaster.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a signed, tamper-proof record. Every cycle is archived according to the plan's retention period, accessible at any time during an Inspection sanitaire visit.
For a detailed comparison, see our digital vs paper register guide.
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