Every dental practice must have a written sterilization protocol. Health authority inspectors check for it, and standardized evaluation grids are the reference. This guide details what your protocol must contain and how to ensure it stands up to inspection.
In France, every dental practice must have a written sterilization protocol, accessible to all staff and available for presentation during inspections. This document describes the procedure to follow at each step of the sterilization chain and assigns responsibilities. The absence of a written protocol is grounds for non-compliance during an ARS (Agence Régionale de Santé -- Regional Health Authority) inspection.
The designation of the 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). The medical waste (DASRI) management procedures. The continuing education plan for staff.
For a step-by-step breakdown of the sterilization chain, see our dental sterilization chain guide.
A cycle is valid when the recorded parameters match the selected programme and all indicators are compliant. In dental practice, the reference cycle is 134°C for 18 minutes (prion cycle), mandatory for instruments in contact with nervous or lymphoid tissue. The autoclave must be Class B to sterilize hollow instruments (turbines, contra-angles) and wrapped loads.
Before the first load of each working day, a Bowie-Dick test (pre-vacuum autoclaves) or Helix test (hollow instruments) validates proper autoclave function. A failed cycle or a non-compliant indicator requires repackaging and resterilization of the entire load.
For details on biological controls, see our autoclave biological controls guide.
The ADF (Association Dentaire Française -- French Dental Association) has published an evaluation grid (2011 and 2015 versions) used as a benchmark by inspectors. It covers the entire process: premises (separate sterilization area, forward flow principle (marche en avant) respected), equipment (validated autoclave, functional ultrasonic bath), procedures (written protocol, traceability, biological controls), and documentation (sterilization register, autoclave maintenance log, training certificates).
Self-evaluating against the ADF grid before an inspection is the best preparation. The most frequently flagged issues: missing instrument-to-patient traceability, absent or incomplete written protocol, undocumented biological controls.
The protocol must define the traceability method used. French law does not prescribe a format -- paper registers remain legally accepted. 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. Each cycle is archived according to the plan's retention period, accessible at any time during an inspection.
For a detailed comparison, see our digital vs paper register guide.
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