Sterilization regulations in Switzerland: what the law requires

Who is required to sterilize instruments?

Sterilization in Switzerland rests on a federal and cantonal framework that varies by profession and supervising authority. For dental practices and podiatry, MePV / ODim Art. 71 and 72 (SR 812.213) govern maintenance and reprocessing, with practice-level inspection by the Kantonsarztamt / Service du médecin cantonal since 1 July 2011; the Swiss Good Practice for Medical Device Reprocessing (GPA 2022), KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) define state-of-the-art compliance. For tattoo, piercing, and permanent makeup, Art. 62 LGV (SR 817.02) requires notification of the activity to the cantonal enforcement authority (Kantonales Labor / ALV / SCAV / SAAV depending on the canton) — federal cantonal notification since 1 May 2017, fully binding since 1 May 2018 — and the EDI Ordinance on objects in human contact (SR 817.023.41) Art. 4 to 7 sets the hygiene obligations. Additional cantonal authorization (Bewilligungspflicht) is required only in Genève and Neuchâtel; all other cantons apply only the federal notification baseline.

The principle is the same for all: every instrument that penetrates the skin barrier or contacts mucous membranes must be either single-use sterile or autoclaved before each use. For prion-relevant procedures, CJKV (SR 818.101.21) prescribes a 134°C / 18-minute cycle. For veterinary practices, no federal autoclave mandate is codified — the GST Code of Professional Conduct 2022 and the BLV / OSAV framework apply (KIGAP explicitly does NOT name veterinary practices among its user groups). For pure nail salons, no federal sterilization mandate; for mixed businesses combining tattoo, piercing, or permanent makeup, Art. 62 LGV and the EDI Ordinance apply in full to the dermopigmentation activity.

SN EN 13060: small steam sterilizers

SN EN 13060 defines the requirements for small steam sterilizers used in practices and studios. It distinguishes three autoclave classes: Class N (solid, unwrapped instruments only), Class S (specific cycles defined by the manufacturer), and Class B (the most versatile — hollow instruments, wrapped loads, textiles). KIGAP 2010 (status 2017) recommends Class B (small / portable / bench-top) for hollow-lumen instruments and wrapped loads — the standard in dental practice and surgical podiatry. For tattoo, piercing, and permanent makeup studios under the EDI Ordinance (SR 817.023.41) and SN EN 17169:2020 (Tattooing — Safe and Hygienic Practice), Class B is the practical standard for any reusable instruments, alongside single-use sterile needles and cartridges. A washer-disinfector (RDG) per SN EN ISO 15883 is state of the art for higher-volume practices.

The autoclave must be validated regularly: a daily Bowie-Dick or Helix test before the first load, and regular biological controls (Geobacillus stearothermophilus spore indicators per SN EN ISO 11138). For more detail, see the autoclave classes guide.

Regulatory bodies

Federal level: BAG / OFSP (Federal Office of Public Health) sets health policy and issues directives — notably BAG Directive 2018/2 of 16 April 2018 and the BAG 'Good Work Practice' Directive of 16 August 2018 for tattoo, piercing, and permanent makeup studios. Swissmedic is the therapeutic-products and medical-devices authority. BLV / OSAV (Federal Food Safety and Veterinary Office) sets the veterinary framework.

Dental, podiatry, dermatology, acupuncture: the Kantonsarztamt / Service du médecin cantonal performs practice-level reprocessing inspection since 1 July 2011 under MePV / ODim Art. 71 and 72. The cantonal practice license (Berufsausübungsbewilligung / autorisation de pratique) is granted by the Cantonal Health Directorate. The Swiss Dental Society (SSO) publishes the Quality Guidelines on Practice Hygiene (2018) and conducts disciplinary proceedings for its members; SPV / FSP / SFPV play this role for podiatry; the FMH for general medicine; SGDV / SSDV for dermatology. Acupuncture in Switzerland is not reserved for physicians — recognition is via the ASCA / EMR (RME) registers, with cantonal authorization in some cantons (Basel-Stadt notably).

Tattoo, piercing, and permanent makeup: the cantonal enforcement authority (Kantonales Labor / ALV / SCAV / SAAV depending on the canton) conducts cantonal enforcement under Art. 62 LGV and the EDI Ordinance on objects in human contact (SR 817.023.41). The VST HQ Label (Verband Schweizerischer Berufstätowierer) is a private industry label — NOT a federal or cantonal certificate.

Veterinary practices: professional oversight by the Swiss Veterinary Society (GST) — Code of Professional Conduct 2022. The BLV / OSAV framework applies; no federal autoclave mandate is codified.

What an inspection checks

For dental practices during a Kantonsarztamt / Service du médecin cantonal reprocessing inspection under MePV / ODim Art. 71 and 72: written hygiene and sterilization protocol per GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018), Spaulding classification of instruments (critical / semi-critical / non-critical), sterilization documentation for every batch — printout or electronic recording of process parameters, daily Bowie-Dick or Helix tests before the first load, regular biological controls with Geobacillus stearothermophilus, staff training records (Dentalassistentin EFZ, Dentalhygienikerin HF), thermal validation per SN EN ISO 17665-1, and — for prion-relevant procedures — the 134°C / 18-minute cycle per CJKV (SR 818.101.21). Switzerland has no codified retention period in MePV; the GPA 2022 and KIGAP recommend alignment with SN EN 868 (packaging) and SN EN ISO 11607 (packaging validation) plus long-term archival for civil-liability purposes.

For tattoo, piercing, and permanent makeup studios during a cantonal enforcement inspection: notification of the activity under Art. 62 LGV, compliance with the EDI Ordinance (SR 817.023.41) Art. 4 to 7 (duty of care, color requirements, ink hygiene, sterile apparatus and instruments), adherence to SN EN 17169:2020, full traceability of inks and single-use devices, signed informed consent with health declaration, incident reporting, and compliance with REACH Annex XVII Entry 75 (transposed into Swiss law via the 8 December 2023 EDI amendment, fully binding since 1 February 2025 — prohibiting Pigment Blue 15:3 and Pigment Green 7). Hepatitis B vaccination is recommended as best practice for practitioners.

Penalties for non-compliance

Dental practices: SSO disciplinary proceedings + suspension or revocation of the cantonal practice license (Berufsausübungsbewilligung / autorisation de pratique) by the Cantonal Health Directorate under MedBG / LPMéd (SR 811.11). Civil liability in case of patient harm.

Tattoo, piercing, and permanent makeup: administrative measures by the cantonal enforcement authority (warnings, fines, business closure) under LMG / LGV. Suspension or revocation of the cantonal Bewilligungspflicht only in Genève and Neuchâtel. Criminal sanctions under LMG / LGV are possible in serious cases. The federal layer remains administrative (notification), not criminal by default.

Podiatry: SPV / FSP disciplinary proceedings + suspension or revocation of the cantonal practice license. Sterilization is codified as a core HF competency by the SBFI Framework Curriculum Podologie HF of 7 February 2022 and the EFZ Ordinance for Podologist (SR 412.101.220); KIGAP explicitly names podologists among the user groups of small steam sterilizers.

Veterinary practices: GST disciplinary proceedings. No federal autoclave mandate — civil liability and professional oversight apply in case of harm to the animal or its owner.