Sterilization regulations in Luxembourg: what the law requires

Who is required to sterilize instruments in Luxembourg?

In Luxembourg, sterilization rests on several distinct frameworks per profession. Tattoo artists, piercers, and permanent makeup practitioners are subject to the Loi du 24 mai 2018 (Memorial A442) and the Règlement grand-ducal du 9 novembre 2018 (Memorial A1048) — one of the most structured frameworks in Europe for the skin-penetration sector, with a mandatory MyGuichet.lu declaration at least one month before opening and a 21-hour hygiene training. Médecins-dentistes operate under the general professional duty (Loi modifiée du 29 avril 1983), the Loi modifiée du 16 janvier 1990 on medical devices, and Regulation (EU) 2017/745 (MDR) directly applicable — no LU-specific règlement grand-ducal on dental sterilization exists. Podiatrists, a profession regulated since the Loi du 29 juin 2023 (Annexe 21 — podologue), practice under the no-blood-drawing rule, which reduces sterilization criticality. Veterinarians follow the Code de déontologie approved by the Arrêté ministériel modifié du 5 mai 2008 — no statutory autoclave mandate.

The principle is the same across all professions: any instrument that penetrates the skin barrier or comes into contact with mucous membranes should either be single-use and sterile, or sterilized in an autoclave before each use.

Standard NF EN 13060: small steam sterilizers

Standard NF EN 13060 defines the requirements for small steam sterilizers used in clinics and studios. It distinguishes three autoclave classes: N (solid, unwrapped instruments), S (specific cycles defined by the manufacturer), and B (the most versatile — hollow instruments, wrapped loads, textiles). The Loi du 24 mai 2018 requires that any material penetrating the skin barrier be sterile: Class B is the reference for hollow instruments in tattoo, piercing, and permanent makeup studios.

The autoclave must undergo regular validation: daily Bowie-Dick or Helix test before the first load, and regular biological controls (Geobacillus stearothermophilus spore indicators) (NF EN 13060, EN ISO 17665-1). For more details, see the autoclave classes guide.

Regulatory bodies

The Inspection sanitaire, part of the Direction de la santé (Ministère de la Santé et de la Sécurité sociale), is the inspecting authority for dental practices, medical practice, and the other health professions. It may conduct inspections at any time and refer violations to the Procureur d'État.

Officers of police judiciaire, in liaison with the Inspection sanitaire, are responsible for inspections of tattoo, piercing, and permanent makeup studios (Loi du 24 mai 2018). Contact: info-tatouage@ms.etat.lu / +352 247-82000.

The Collège médical is the disciplinary authority of the medical profession (médecins, médecins-dentistes, pharmaciens). It may impose sanctions ranging from a warning to removal from the register. The Ministre de la Santé may suspend or withdraw the authorization to practice in case of serious misconduct.

The Collège vétérinaire is the disciplinary authority of the veterinary profession (Loi du 31 mai 2002 + Arrêté ministériel modifié du 5 mai 2008 — Code de déontologie). AMMD (Association des Médecins et Médecins-Dentistes) and AMVL (Association des Médecins Vétérinaires) are the reference professional associations.

The MyGuichet.lu platform is the government portal where the prior declaration for tattoo, piercing, and permanent makeup activities is filed (at least one month before opening). The CNS (Caisse Nationale de Santé) manages reimbursement nomenclature — it is not a hygiene regulator.

What an inspector checks

During a tattoo, piercing, or permanent makeup studio inspection, officers of police judiciaire verify: a current MyGuichet.lu declaration, the 21-hour hygiene and sanitation training certificate for every practitioner, Hepatitis B vaccination, autoclave compliance (NF EN 13060, Class B recommended), cycle traceability (complete register with date, parameters, result), process and biological indicators, use-by dates on pouches, REACH compliance of inks (Annex XVII Entry 75 — Pigment Blue 15:3 and Pigment Green 7 banned since 4 January 2023), infectious waste management (Loi modifiée du 21 mars 2012 on waste), and that the sterilization room follows the one-way workflow (marche en avant).

For dental practices, the Inspection sanitaire (Direction de la santé) verifies the same technical elements, framed by the general professional duty, the Loi modifiée du 16 janvier 1990, and Regulation (EU) 2017/745: written and accessible protocol, traceability record for every cycle, daily Bowie-Dick / Helix tests, biological controls, up-to-date register, NF EN 13060 compliance.

Penalties for non-compliance

For tattoo artists, piercers, and permanent makeup practitioners: enforcement by officers of police judiciaire (Loi du 24 mai 2018), criminal and administrative sanctions, possible closure of the establishment. Any violation of the hygiene and sanitation conditions may result in proceedings before the Procureur d'État.

For médecins-dentistes and médecins: disciplinary sanctions by the Collège médical (up to removal from the register), possible suspension or withdrawal of the authorization to practice by the Ministre de la Santé, criminal consequences in case of patient harm. The Inspection sanitaire may refer violations to the Procureur d'État.

For podiatrists: sanctions related to ministerial authorization (Loi du 29 juin 2023, Annexe 21), consequences in case of professional misconduct.

For veterinarians: disciplinary sanctions by the Collège vétérinaire based on the Code de déontologie (Arrêté ministériel modifié du 5 mai 2008). General civil and criminal liability applies in case of harm.

Regulations by profession