Traceability guide for tattoo studios in Switzerland

Step 1: Receiving and sorting instruments

At the end of each session, reusable instruments (tubes, grips, forceps) are immediately placed in a pre-disinfection tray with enzymatic or detergent-disinfectant solution. Single-use instruments (needles, tips, ink cups) are disposed of in the regulated waste container. Never mix the two categories. Immediate separation protects staff during subsequent handling and prevents cross-contamination.

Step 2: Cleaning and packaging

After pre-disinfection (duration depends on the product, typically 15-30 minutes), instruments are rinsed with clean water, thoroughly dried, and placed in sterilization pouches (heat-sealable paper/plastic) per SN EN 868. Each pouch is sealed and marked with a process indicator (Class 1 autoclave tape per SN EN ISO 11140-1). Thorough drying before packaging is essential — moisture trapped inside a pouch compromises packaging integrity and sterilization efficacy.

Step 3: Autoclave cycle

Pouches are loaded into the autoclave following the manufacturer's loading instructions (do not overload, do not stack pouches). The recommended cycle is 121°C / 15 min OR 134°C / 5.5 min with saturated steam. The autoclave generates a report at the end of the cycle — this report is the proof that sterilization parameters were reached. In Switzerland, Class B per SN EN 13060 is the practical standard for any reusable instruments, alongside single-use sterile needles and cartridges. SN EN 17169:2020 ("Tattooing — Safe and Hygienic Practice") is the European reference standard.

Before the first load of the day, run 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 1-2 months for a single-layer pouch — Switzerland has no codified retention period; the GPA 2022 and KIGAP recommend alignment with SN EN 868 and SN EN ISO 11607), and the identification of the contents. With traceability software like SecuSteri, the label includes a QR code linking the pouch directly to the autoclave cycle report.

The pouch is opened in front of the client to demonstrate that the instrument is sterilized and within its use-by date. This is particularly important in tattoo and piercing, where client trust depends on process transparency.

Step 5: Storage

Sterilized 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. The storage area must be separated from the work area — the BAG 'Good Work Practice' Directive of 16 August 2018 recommends a clear separation between the contaminated zone (pre-disinfection), the clean zone (packaging and autoclave), and the sterile storage area. The treatment room must be used exclusively for tattooing, separated from reception and waiting areas.

Step 6: Recording and archiving

Each cycle is recorded with: date, time, cycle number, parameters (temperature, pressure, hold time), result (pass / fail), and operator identity. The autoclave report is retained (in paper or digital format). Switzerland has no codified retention period in MePV for tattoo, piercing, and permanent makeup studios; the GPA 2022 and KIGAP recommend long-term archival for civil-liability purposes. During an inspection by the cantonal enforcement authority (Kantonales Labor / ALV / SCAV / SAAV depending on the canton), all records must be available for review.

Additionally, each tattoo, piercing, or permanent makeup session must document: client data (name, identification document, signed informed consent with health declaration, age verification), description of the work performed, instruments used (with reference to the sterilization cycle), inks or products used (batch number, manufacturer, compliance with REACH Regulation Annex XVII Entry 75 — Pigment Blue 15:3 and Pigment Green 7 prohibited in Switzerland since 1 February 2025, transposed via the 8 December 2023 EDI amendment), and any incidents. Hepatitis B vaccination of the tattoo artist is recommended as best practice in Switzerland.

The Swiss framework: federal notification + cantonal Bewilligungspflicht escalation only in Genève and Neuchâtel

Every tattoo studio in Switzerland must notify the cantonal enforcement authority of its activity since 1 May 2017 (Art. 62 LGV — federal cantonal notification, fully binding since 1 May 2018). The EDI Ordinance on objects in human contact (SR 817.023.41) Art. 4 to 7 sets the obligations: duty of care (Art. 4), color requirements (Art. 5), ink hygiene (Art. 6), and sterile apparatus and instruments (Art. 7). EDI Ordinance Art. 3 defines permanent makeup as the microimplantation of pigments with less persistence than tattooing — same obligations as tattooing.

The BAG Directive 2018/2 of 16 April 2018 and the BAG 'Good Work Practice' Directive of 16 August 2018 guide cantonal enforcement. Additional cantonal authorization (Bewilligungspflicht) is required only in Genève and Neuchâtel — all other cantons apply only the federal notification baseline. For tattoo artists working at conventions or guest spots, the Swiss framework applies everywhere — a digital, portable register like SecuSteri makes it possible to demonstrate compliance to any cantonal enforcement authority inspection, regardless of location. The VST HQ Label (Verband Schweizerischer Berufstätowierer) is a private industry label — NOT a federal or cantonal certificate.

Common mistakes

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. Not documenting inks with batch number and REACH compliance (Pigment Blue 15:3 and Pigment Green 7 prohibited in Switzerland since 1 February 2025). Not obtaining signed informed consent with health declaration before each session. Not notifying the new activity or change of address to the cantonal enforcement authority under Art. 62 LGV. In Genève and Neuchâtel, forgetting to apply for the cantonal Bewilligungspflicht in addition to the federal notification.

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