The Standards for Tattoo and Body Piercing (January 2025) bind every Maltese tattoo studio, with EN 17169:2020 (Tattooing — Safe and Hygienic Practice) explicitly cited as the European standard. The Control of Tattooing Act (Chapter 270 of the Laws of Malta) restricts possession of tattooing instruments to authorised practitioners and prohibits tattooing persons under 18. The studio partition rule (≥2m × 2m impervious opaque material), the single-use sterile needle rule, the HCSD-approved ink rule, and the prohibition of powdered and polythene gloves are all structural requirements. This guide details every step from receiving instruments to archiving records — the documentation HCSD inspectors expect to see.
At the end of each session, reusable instruments (tubes, grips, forceps) are immediately placed in a pre-disinfection tray. Single-use sterile needles, cartridges, tips, and ink cups are disposed of in the clinical waste container — the Standards for Tattoo and Body Piercing (January 2025) and the Control of Tattooing Act (Chapter 270 of the Laws of Malta) require single-use needles only, with no reuse permitted. Never mix the two categories.
After pre-disinfection (duration depends on the product), instruments are rinsed, dried, and placed in sterilisation pouches. Each pouch is sealed and marked with a process indicator (autoclave tape). The pouch is dated and numbered, and the use-by date is marked at packaging time.
The pouches are loaded into a Class B steam steriliser compliant with EN 13060 and validated per EN ISO 17665-1. 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 the proof that the required parameters were reached.
Before the first load of the day, run a Bowie-Dick or Helix test to verify steam penetration. Maintain regular biological controls (Geobacillus stearothermophilus spore indicators) to confirm sterilisation effectiveness.
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 away 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), and operator identity. The autoclave report is retained (in paper or digital format). Studios should also retain the client record — date, anatomical area, ink batch numbers, single-use device batch numbers, signed informed client consent with health-status declaration, and any incident reports.
The Standards for Tattoo and Body Piercing (January 2025) is binding under HCSD authority and explicitly cites EN 17169:2020 (Tattooing — Safe and Hygienic Practice) as the European standard. These records are your evidence for an HCSD inspection.
Tattoo, body piercing, and semi-permanent makeup in Malta are bound by the Standards for Tattoo and Body Piercing (January 2025), which explicitly cites EN 17169:2020 as the European standard. Body piercing is also regulated by the Body Piercing (Control) Regulations (S.L. 465.07) under the Public Health Act (Chapter 465). The Control of Tattooing Act (Chapter 270 of the Laws of Malta) prohibits tattooing of persons under 18 and restricts possession of tattooing instruments to authorised practitioners; the MT Standards for Tattoo and Body Piercing consent-form template names the semi-permanent artist as a regulated practitioner role alongside the tattoo artist and the body piercer. HCSD inspects unannounced and enforces the Standards' structural requirements.
Structural rules apply to every Maltese tattoo, piercing, and semi-permanent makeup studio: workstations must be separated from adjacent areas by a fixed partition of impervious opaque material at least 2m × 2m; powdered gloves and polythene gloves are prohibited; nail polish and artificial fingernails are prohibited during practice; individually wrapped sterile surgical gloves are required for piercing procedures; inks must come from HCSD-approved suppliers and comply with EU REACH Annex XVII Entry 75 (Pigment Blue 15:3 and Pigment Green 7 banned since 4 January 2023); practitioners performing Exposure Prone Procedures should document Hepatitis B vaccination.
Not filling in the record immediately after the cycle (forgetting). Not marking the use-by date on the pouch. Storing pouches in an open or humidity-exposed drawer. Not performing the daily Bowie-Dick test. Not keeping autoclave reports. Using a pouch past its use-by date without reprocessing. Using powdered or polythene gloves (prohibited). Sourcing inks from non-HCSD-approved suppliers.
Verify every compliance point before the inspector arrives. Download the PDF instantly — no email required.