The Royal Decree of 25 November 2005 requires Belgian tattoo artists to use a Class B autoclave, hold ministerial approval, and follow strict hygiene procedures. This guide details how to organize your traceability to meet these requirements.
At the end of each session, reusable instruments (tubes, grips, forceps) are immediately placed in a pre-disinfection bath. Single-use instruments (needles, nozzles, ink caps) are discarded in the medical waste container. Never mix the two categories.
After pre-disinfection (duration depends on the product), instruments are rinsed, dried, then placed in sterilisation pouches. Each pouch is sealed and carries a process indicator (autoclave tape). The pouch is dated and numbered.
Pouches are placed in the autoclave. In Belgium, the Royal Decree of 25/11/2005 requires a Class B autoclave for tattoo studios. The recommended cycle is 134°C for 18 minutes (prion cycle). The autoclave prints a report (ticket or file) at the end of the cycle. This report is proof that the required parameters were achieved.
Before the first load of the day, perform a Bowie-Dick or Helix test to verify steam penetration.
After the cycle, each pouch receives a traceability label showing: the cycle number, the sterilisation date, the use-by date (typically 2 months for a single-layer pouch), and the identification of the contents.
With traceability software, the label can include a QR code linking the pouch directly to the autoclave cycle report.
Sterilised pouches are stored in a clean, dry, enclosed space protected from dust. The first-in, first-out (FIFO) principle applies: the oldest pouches are used first.
Each cycle is recorded in the sterilisation register with: date, time, cycle number, parameters (temperature, pressure, duration), result (pass/fail), operator identity. The autoclave report is kept (on paper or as a digital file).
The Royal Decree of 25/11/2005 requires documented sterilisation protocols. These documents must be accessible during an FPS Public Health inspection.
Non-compliance with the Royal Decree of 25/11/2005 carries severe penalties in Belgium: sentences range from 8 days to 3 years of imprisonment and/or fines from €160 to €4,000,000. The FPS Public Health can order studio closure in cases of serious non-compliance.
Ministerial agrément, the 20-hour hygiene training certificate, and compliance with sterilisation protocols are mandatory conditions for operating. The absence of any of these constitutes grounds for sanctions.
Not filling in the record immediately after the cycle (forgotten). Not writing the use-by date on the pouch. Storing pouches in an open drawer or one exposed to humidity. Not performing the daily Bowie-Dick test. Not keeping autoclave reports. Using a pouch past its use-by date without reprocessing. Using a Class N autoclave when Class B is required.
Verify every compliance point before the inspector arrives. Enter your email and receive the checklist immediately.