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.
Every dental practice must have a written sterilization protocol, accessible to all staff and presented 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 a health authority inspection.
Designation of the person responsible for sterilization within the practice. Detailed description of each step in the sterilization chain (pre-disinfection, cleaning, rinsing, drying, packaging, autoclave, storage). Autoclave maintenance and validation schedule (initial qualification, annual requalification, preventive maintenance). Frequency of biological and physicochemical controls. Traceability method used (paper or digital register). Waste management procedures (clinical waste). Staff continuing education plan.
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 program and all indicators are conforming. In dental practices, 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 non-conforming indicator requires repackaging and resterilizing the entire load.
For detailed information on biological controls, see our autoclave biological controls guide.
Health authorities evaluate dental sterilization practices against standardized criteria. In France, the Association Dentaire Française (ADF) grid is the reference. Internationally, similar checklists assess the same core areas: premises (separate sterilization zone, forward flow 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 these criteria before an inspection is the best preparation. The most frequently flagged points across jurisdictions: missing instrument-to-patient traceability, absent or incomplete written protocol, undocumented biological controls.
Your protocol must define the traceability method used. The law does not mandate a format — the paper register remains legally accepted. But its 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 duration, accessible at any time during an inspection.
For a detailed comparison, see our digital vs paper register guide.
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