French law requires a traceability record for every sterilization cycle — but does not prescribe a standard form. This guide details the mandatory fields, the legal basis for each profession, and how a digital system can generate compliant sheets automatically.
French regulations require a traceability record for every sterilization cycle, but do not prescribe a standard form. For tattoo artists, piercers, and permanent makeup professionals, the Order of 11 March 2009 (Arrêté du 11 mars 2009, Annex) states: "A traceability record shall be established for each disinfection/sterilization." For dental practices, Art. L.5212-1 of the Public Health Code requires a register linking cycles to patient records. For podiatrists, the ONPP (Ordre National des Pédicures-Podologues — podiatry regulatory body) requires the patient-instrument-cycle link and a 5-year retention period.
The absence of a standard form means each professional is responsible for ensuring their record contains the necessary information. This guide details the mandatory fields. For full regulatory requirements, see the sterilization regulations guide.
Every traceability sheet must include at minimum: the date and time of the cycle, autoclave identification (name or serial number), the cycle number or batch number, the cycle type (standard 134°C/5.5 min or prion 134°C/18 min), the recorded parameters (temperature, pressure, duration), the cycle result (pass or fail), the identity of the operator who loaded and validated the cycle, and the list of instruments or pouches included in the load.
For dental practices, the ADF (Association Dentaire Française) evaluation grid adds further requirements: the link to the patient record (which patient received which instruments), the daily Helix or Bowie-Dick test results, and the use-by date (DLU — date limite d'utilisation) marked on each pouch. For details on use-by dates, see the use-by date guide.
A dental practice must link each cycle to the patient record — this is the strictest requirement. Tattoo artists and piercers must establish a record per cycle under the Order of 11 March 2009, but the patient link is not explicitly required. Podiatrists are in an intermediate position: the ONPP requires the patient-instrument-cycle link, even though no regulatory text formally prescribes it. The ONPP also states that the autoclave's USB stick does not constitute adequate traceability — it contains only cycle parameters, not the load contents.
The DGS Guide 2006 recommends 5-year retention for sterilization records in dental practices. The ONPP also prescribes 5 years for podiatrists. For tattoo artists and piercers, the Order of 11 March 2009 does not set an explicit retention period, but standard practice and ARS (regional health agency) recommendations align on 5 years. In case of litigation, traceability records can serve as evidence — so it is prudent to retain them as long as necessary.
On paper, the record is filled in by hand after each cycle: date, time, cycle number, instrument list, signature. The risks: forgetting to fill it in, illegible handwriting, lost binders, no quick search capability. With a digital register like SecuSteri, the traceability sheet is generated automatically from the imported autoclave report. The operator signs the cycle with their PIN code, the instruments in the load are linked to the cycle, and a QR label is printed for each pouch. The complete record is instantly accessible during an inspection.
For a detailed comparison between paper and digital registers, see our digital register guide.
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