Traceability guide for tattoo studios in Luxembourg

Step 1: Receiving and sorting instruments

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 infectious waste container (Loi modifiée du 21 mars 2012 on waste). Never mix the two categories.

Step 2: Cleaning and packaging

After pre-disinfection (duration depends on the product), instruments are rinsed, dried, then placed in sterilization pouches. Each pouch is sealed and carries a process indicator (autoclave tape, per EN ISO 11140-1). The pouch is dated and numbered.

Step 3: Autoclave cycle

Pouches are placed in the autoclave. In Luxembourg, the Loi du 24 mai 2018 (Memorial A442) and the Règlement grand-ducal du 9 novembre 2018 (Memorial A1048) require that any material penetrating the skin barrier be sterile: a Class B autoclave (NF EN 13060) is the reference for hollow instruments in tattoo, piercing, and permanent makeup studios. The recommended cycle is 134°C for 18 minutes (prion cycle) or 134°C for 3 minutes (standard 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.

Step 4: Labeling and use-by date

After the cycle, each pouch receives a traceability label showing: the cycle number, the sterilization date, the use-by date (typically 2 months for a single-layer pouch, up to 6 months for a double-wrapped pouch per NF EN 868 and EN ISO 11607), 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.

Step 5: Storage

Sterilized 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.

Step 6: Recording and archiving

Each cycle is recorded in the sterilization 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 client record must also include the batch numbers of inks and pigments used (REACH compliance — Regulation (EU) 1907/2006 Annex XVII Entry 75, in force since 4 January 2022; Pigment Blue 15:3 and Pigment Green 7 banned since 4 January 2023).

The Loi du 24 mai 2018 and the Règlement grand-ducal du 9 novembre 2018 require documented sterilization protocols. These documents must be accessible during an inspection by officers of police judiciaire in liaison with the Inspection sanitaire (contact: info-tatouage@ms.etat.lu / +352 247-82000).

Penalties for non-compliance

Non-compliance with the Loi du 24 mai 2018 and the Règlement grand-ducal du 9 novembre 2018 exposes operators to enforcement by officers of police judiciaire: criminal and administrative sanctions, possible closure of the establishment, proceedings before the Procureur d'État. Any violation of the hygiene and sanitation conditions may be reported to the Inspection sanitaire.

A current MyGuichet.lu declaration, the 21-hour hygiene and sanitation training certificate, and compliance with sterilization protocols are mandatory conditions for operating. The absence of any of these constitutes grounds for sanctions.

Common mistakes

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 an autoclave unsuited to hollow instruments penetrating the skin barrier. Not documenting ink batch numbers (REACH breach). Failing to update the MyGuichet.lu declaration when premises, staff, or practiced technique changes.

Further resources