Sterilization regulations in Austria: what the law requires

Who is required to sterilize instruments?

Austria operates under a federally uniform framework. At federal level, the Medizinproduktebetreiberverordnung (MPBV, BGBl. II Nr. 70/2007 idgF), based on the Medizinproduktegesetz 2021 (MPG 2021), governs the reprocessing of medical devices in healthcare facilities. ÖGSV-Leitlinie 11 (2024) provides authoritative technical guidance and represents the state of science and technology. For dental practices, the ÖZÄK-Hygieneverordnung 2025 (Verordnung der Österreichischen Zahnärztekammer) has additionally been in force since 1 May 2025: Anlage 1 makes the minimum format of the Hygieneplan and cleaning/disinfection plan binding; Anlage 2 assigns each procedure to one of 4 risk categories (A/B/C/D); § 24 Abs. 3 sets 1 May 2028 as the deadline for existing practices to install a Class B sterilizer + washer-disinfector (RDG).

Tattoo artists, piercers, and permanent makeup practitioners fall under the federal-uniform ARPTV (BGBl. II Nr. 141/2003 idgF) and ARFKMV (BGBl. II Nr. 262/2008 idgF) -- § 4 ARFKMV requires an annual Unbedenklichkeitsnachweis (UbN) issued by an Akkreditierung Austria-accredited body, § 5 ARPTV requires 10-year retention. Veterinary practices fall under the Ordinationsrichtlinie 2022 (OrdiRL) of the Österreichische Tierärztekammer: § 4 Abs. 1 Z 2 lit. h makes a sterilizer or autoclave mandatory minimum equipment since 6 December 2022. Physician practices including dermatology and physician-led acupuncture fall under the ÄK-Hygieneverordnung 2014 (3rd amendment 2022). Foot care (Fußpflege) is a licensed trade under § 94 Z 23 GewO 1994 in Austria -- the regulated healthcare profession of "Podologe/Podologin" does not exist here; Anlage 1 ARFKMV hygiene rules apply. Pure nail salons fall under the Kosmetik trade category per § 94 Z 42 GewO 1994 with Anlage 1 ARFKMV hygiene rules -- with no sterilization mandate.

ÖNORM EN 13060: small steam sterilizers

ÖNORM EN 13060:2025-10-15 is the Austrian adoption of the European standard EN 13060, defining 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). For oral surgery procedures under Anlage 2 ÖZÄK-HygV 2025 Category D (e.g., implantation, flap procedures), Class B is already mandatory now; for dental practices that existed on 1 May 2025, Class B becomes mandatory by 1 May 2028 at the latest (§ 24 Abs. 3). A washer-disinfector (RDG) per ÖNORM EN ISO 15883 is required on the same timeline. For tattoo studios using hollow instruments, Class B is the state of the art within the framework of the § 4 ARFKMV Unbedenklichkeitsnachweis.

Regulatory bodies

Dental -- Landeszahnärztekammern and Bezirksverwaltungsbehörden: The Österreichische Zahnärztekammer (ÖZÄK) and the competent Landeszahnärztekammer oversee compliance with the ÖZÄK-Hygieneverordnung 2025; disciplinary jurisdiction lies with the Disziplinarrat der ÖZÄK under § 62 ZÄKG. The Bezirksverwaltungsbehörde (Bezirkshauptmannschaft outside statutory cities; Magistrat in Vienna and other Statutarstädte) conducts Ordinationsüberprüfungen under § 36 Abs. 2 ZÄG -- announced or unannounced. ÖGSV-Leitlinie 11 (2024) is the technical best-practice reference.

Tattoo, piercing, and permanent makeup: The federal-uniform ARPTV/ARFKMV regulate hygiene requirements identically across all 9 Bundesländer. ÖNORM EN 17169:2020 defines the state of the art. The annual Unbedenklichkeitsnachweis under § 4 ARFKMV is issued by an Akkreditierung Austria-accredited body (e.g., HygCen Austria, WHU GmbH). Oversight: Bezirksverwaltungsbehörde / Gewerbebehörde.

Veterinary practices: Oversight by the Österreichische Tierärztekammer and the Bezirksverwaltungsbehörde under § 16 Abs. 4 TÄG. Disciplinary jurisdiction: Disziplinarkommission der Tierärztekammer under § 66 TÄKamG.

Physician practices (dermatology, acupuncture): Oversight by the Österreichische Ärztekammer (ÖÄK) and the competent Landesärztekammer. Acupuncture in Austria is strictly reserved for physicians under § 2 Abs. 2 ÄrzteG 1998 -- no non-physician therapeutic profession authorized to perform acupuncture exists in Austria; practitioners typically hold the ÖÄK-Diplom Akupunktur.

Foot care (Fußpflege): licensed trade under § 94 Z 23 GewO 1994 -- oversight by the Bezirksverwaltungsbehörde / Gewerbebehörde. The ÖGSV-Stellungnahme S-08 (2017) on the reprocessing of foot care instruments is the technical best-practice reference; the § 4 ARFKMV UbN obligation does NOT apply to pure Fußpflege businesses.

What the Bezirksverwaltungsbehörde checks during an Ordinationsüberprüfung

During an Ordinationsüberprüfung under § 36 Abs. 2 ZÄG, dental practices are checked on: Hygieneplan per Anlage 1 ÖZÄK-HygV 2025 (mandatory minimum format), cleaning and disinfection plan per Anlage 1, risk classification of procedures per Anlage 2 (A/B/C/D), sterilization documentation for every batch -- as printout or electronic storage of process parameters (§ 20 Abs. 5 ÖZÄK-HygV 2025 -- both explicitly equivalent), daily Bowie-Dick/Helix tests before the first load, regular biological controls with Geobacillus stearothermophilus, staff Sachkenntnisnachweis (MPBV), 7-year retention per § 6 Abs. 3, and maintenance documentation for reprocessing equipment. For tattoo, piercing, and PMU studios, the annual Unbedenklichkeitsnachweis (UbN) is the central inspection document.

Penalties for non-compliance

Dental practices: Disciplinary sanctions per § 58 Abs. 1 ZÄKG: written reprimand · monetary penalty up to €40,000 · temporary prohibition of professional practice · removal from the dental register. Disciplinary jurisdiction: Disziplinarrat der Österreichischen Zahnärztekammer (§ 62 ZÄKG); appeal to LVwG of the Land.

Tattoo, piercing, and permanent makeup: Administrative fine under § 366 GewO 1994 up to €3,600 · failure to present the annual Unbedenklichkeitsnachweis under § 4 ARFKMV is punishable and may lead to revocation of the Gewerbeberechtigung · closure of operations may be ordered by the Gewerbebehörde. The federal-uniform regulation applies identically across all 9 Bundesländer.

Veterinary practices: Disciplinary sanctions per § 64 Abs. 1 TÄKamG: written reprimand · monetary penalty up to thirty times the chamber dues for self-employed members · temporary prohibition of professional practice · removal from the veterinary register. Disciplinary jurisdiction: Disziplinarkommission der Tierärztekammer (§ 66 TÄKamG); appeal to LVwG of the Land.

Regulations by profession