The traceability sheet links each sterilized instrument to its autoclave cycle, operator, and expiry date. This guide explains its content and how SecuSteri generates it automatically.
In Belgium, sterilisation traceability is not governed by a standard form, but the requirements are clear. For tattoo artists and piercers, the Royal Decree of 25/11/2005 mandates documented sterilisation protocols as part of the ministerial agrément. For dental practices, the CSS/HGR (opinion 8363) recommends a register linking cycles to patient records. For podiatrists, CSS/HGR 9682 recommends traceability of reusable medical devices.
The absence of a standard form means each professional is responsible for ensuring their record contains the necessary information. This guide details the required fields. For full regulatory requirements, see the sterilisation regulations guide.
Each traceability record should contain at minimum: the date and time of the cycle, autoclave identification (name or serial number), cycle or batch number, cycle type (standard 134°C/5.5 min or prion 134°C/18 min), recorded parameters (temperature, pressure, duration), cycle result (pass or fail), identity of the operator who loaded and validated the cycle, and the list of instruments or pouches in the load.
For dental practices, the CSS/HGR adds further requirements: the link to the patient record (which patient received which instruments), the day's Helix or Bowie-Dick test results, and the use-by date on each pouch. For more on the use-by date, see the use-by date guide.
A dental practice must link each cycle to the patient record — this is the strictest CSS/HGR requirement. Tattoo artists and piercers must document their sterilisation protocols as part of the AR 25/11/2005 agrément. Podiatrists occupy a middle ground: CSS/HGR 9682 recommends the patient-instrument-cycle link as part of paramedical best practice.
CSS/HGR recommendations advise retaining sterilisation records for at least 5 years in dental practice. For tattoo artists and piercers, client registers and declarations must be kept in accordance with the AR 25/11/2005. In case of litigation, traceability records can serve as evidence — it is therefore prudent to retain them for 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: forgotten entries, illegible handwriting, lost binders, inability to search quickly. With a digital register like SecuSteri, the record 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 viewable during an FPS Public Health inspection.
For a detailed comparison between paper and digital registers, see our digital register guide.
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