Instrument sterilization is a legal obligation for many professionals in France. This guide summarizes the applicable laws, enforcement bodies, and penalties.
In France, several categories of professionals are required to sterilize their instruments. Tattoo artists, piercers, and permanent makeup practitioners are governed by Décret n°2008-149 of 19 February 2008. Dentists fall under the Code de la santé publique (Art. R.4127-204 and Art. L.5212-1) and DGS circulars. Podiatrists are governed by Art. R.4322-77 CSP and ONPP recommendations.
The principle is the same for all: any instrument penetrating the skin barrier or contacting mucous membranes must be either single-use and sterile, or sterilized in an autoclave before each use.
The NF EN 13060 standard defines requirements for small steam sterilizers used in practices 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, textiles). Class B is recommended by the ONPP for podiatry and considered the reference for all professionals.
The autoclave must undergo regular validation: daily Bowie-Dick or Helix test before the first load, and regular biological controls (spore indicators).
The ARS (Agence Régionale de Santé) inspects tattoo, piercing, and permanent makeup studios. It can conduct unannounced inspections and order immediate suspension of activity for non-compliance.
The Ordre National des Pédicures-Podologues (ONPP) monitors podiatry practice sterilization compliance. The CPAM may also audit practices in connection with reimbursement of podiatric care (particularly for diabetic patients).
The Ordre des chirurgiens-dentistes and the ARS jointly monitor dental practices. Dental centers have been subject to intensified scrutiny since 2022.
During an inspection, the inspector verifies autoclave compliance (class, validation, maintenance), cycle traceability (complete register with date, time, parameters, instrument-patient link), process indicators and biological controls, use-by dates on pouches, DASRI waste management, and staff training (hygiene certification for tattoo/piercing/PMU, continuing education for healthcare professionals).
For tattoo artists, piercers, and PMU practitioners: 5th class offence (up to €1,500 per infraction, €3,000 for repeat offences), suspension of activity by the ARS.
For dentists: disciplinary sanctions from the Ordre, criminal prosecution, fines up to €80,000 (Centre Dentaire de Vincennes precedent, 2025), suspension of activity.
For podiatrists: disciplinary sanctions from the Ordre, CPAM reimbursement consequences, criminal prosecution in case of patient harm.
Verify every compliance point before the inspector arrives. Enter your email and receive the checklist immediately.