Instrument sterilization is a legal obligation for many professionals in Romania. This guide summarizes the applicable legislation — including Ordinul MS 1761/2021 for dental and Ordinul MS 1648/2024 for tattoo and piercing — the enforcement role of DSP (Direcția de Sănătate Publică), and the penalties for non-compliance.
In Romania, several categories of professionals are required to sterilize their instruments. Dental practices are regulated by Ordinul MS nr. 1761/2021 on cleaning, disinfection, and sterilization, supplemented by Ordinul MS nr. 1338/2007 on the functional structure of dental offices. Tattoo, piercing, and permanent makeup studios are regulated by Ordinul MS nr. 1648/2024 on hygiene standards for body beautification salons. Nail salons fall under the same regulation (Ord. 1648/2024). Dermatology practices follow the general standards for medical offices (Ord. 1761/2021).
The principle is the same for all: any instrument that penetrates the skin barrier or comes into contact with mucous membranes must be either single-use and sterile, or sterilized in an autoclave before each use.
The 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 loads, textiles). Class B is the reference for all regulated professions, being the only class capable of sterilizing hollow instruments and wrapped loads.
The autoclave must undergo regular validation: a daily Bowie-Dick or Helix test before the first load, Class 5 chemical integrators for every batch as required by Ordinul 854/2022, and biological tests (spore indicators) at regular intervals.
DSP (Directia de Sanatate Publica — Public Health Directorate) inspects all medical facilities and body beautification salons. DSP can conduct unannounced inspections and order suspension of activity for non-compliance. In 2018, DSP inspectors carried out 13,400 inspections nationwide and imposed fines totaling 1,660,900 lei.
CMSR (Colegiul Medicilor Stomatologi din Romania — Romanian Dental College) is the professional body that issues membership certificates and can impose disciplinary sanctions on dental practices.
For tattoo, piercing, and permanent makeup studios, DSP is the enforcement authority. Ordinul 1648/2024 (published April 2024) updated and tightened the requirements — many studios are still in the process of achieving compliance.
During an inspection, DSP inspectors verify: autoclave compliance (class, validation, maintenance), cycle traceability (complete register with date, time, parameters, instrument-to-patient link), process indicators and biological tests, use-by date (DLU) on pouches, medical waste management, and staff training (hygiene certificate for tattoo/piercing/permanent makeup, continuing education for healthcare professionals).
For dental practices (HG nr. 857/2011, amended by HG nr. 638/2019): failure to follow sterilization procedures — 1,000-3,000 lei (~200-600 EUR) for individuals, 20,000-30,000 lei (~4,000-6,000 EUR) for legal entities. Missing sterilization documentation — 500-1,000 lei (~100-200 EUR) for individuals, 5,000-15,000 lei (~1,000-3,000 EUR) for legal entities.
For tattoo, piercing, and permanent makeup studios: using instruments without sterilization or missing sterilization records — 1,000-3,000 lei (~200-600 EUR) for individuals, 20,000-30,000 lei (~4,000-6,000 EUR) for legal entities.
Important context: dental procedures are identified as the leading documented route of Hepatitis B transmission in Romania (8.7% of cases). Proper sterilization traceability is not just a legal obligation — it is an essential safeguard against civil and criminal liability.
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