ÖNORM EN 13060:2025-10-15 defines three classes of small steam sterilizers. The ÖZÄK-Hygieneverordnung 2025 makes Class B sterilizers mandatory for existing dental practices by 1 May 2028 at the latest (§ 24 Abs. 3). For oral surgery procedures (Anlage 2 Category D — implantation, flap procedures), Class B is already mandatory now. For tattoo studios, Class B is the state of the art. Choosing the wrong class means your instruments may not be sterilized.
ÖNORM EN 13060:2025-10-15, the Austrian adoption of the European standard EN 13060, classifies small steam sterilizers into three classes based on their steam penetration capability and the load types they can process. This classification determines which instruments each autoclave can sterilize and, therefore, which class is appropriate for each profession. The ÖZÄK-Hygieneverordnung 2025 requires the use of standards-compliant reprocessing equipment. Anlage 2 assigns each procedure type to a required reprocessing method (Categories A/B/C/D), and § 24 Abs. 3 makes Class B mandatory for existing dental practices by 1 May 2028.
Class B (Big autoclave, small sterilizer) is the most versatile class. It features a fractionated pre-vacuum system that evacuates air from the chamber and from the internal channels of hollow instruments (dental turbines, contra-angle handpieces, cannulae) before steam injection. Only Class B can reliably sterilize wrapped loads, hollow instruments, and textiles.
In Austria, Class B is already mandatory now for oral surgery procedures (Anlage 2 Category D -- implantation, flap procedures). For dental practices that existed on 1 May 2025, it becomes mandatory by 1 May 2028 at the latest -- together with a washer-disinfector (RDG) per ÖNORM EN ISO 15883 (§ 24 Abs. 3 ÖZÄK-Hygieneverordnung 2025). ÖGSV-Leitlinie 11 (2024) recommends Class B as the standard for all dental practices. For tattoo studios using hollow instruments, Class B is likewise the state of the art and the practical baseline for the annual Unbedenklichkeitsnachweis (UbN) under § 4 ARFKMV.
Class N (Naked) can only process solid, unwrapped, non-hollow instruments. There is no pre-vacuum -- air displacement occurs by gravity, which is insufficient for hollow instruments or wrapped loads. Instruments sterilized in a Class N autoclave must be used immediately after the cycle, as they lose sterility upon contact with ambient air without packaging.
In Austrian practice, Class N has very limited application: it does not allow sterilization of wrapped instruments (no use-by date possible per § 21 ÖZÄK-HygV 2025), cannot process hollow instruments, and does not provide the traceability required by the ÖZÄK-Hygieneverordnung 2025 together with Anlage 1. Its use is restricted to immediate sterilization of emergency instruments.
Class S (Specified) is an intermediate category defined by the manufacturer's specifications. The manufacturer declares which load types their Class S autoclave can process (e.g., "solid wrapped instruments" or "hollow type A instruments"). The available cycles and permitted loads vary from model to model -- there is no single standard for Class S.
Before purchasing a Class S autoclave, it is essential to verify that the manufacturer's declared cycles cover the specific requirements of your practice. When in doubt, Class B is always the safest choice: it covers all load types and avoids the risk of using an unsuitable cycle for a particular instrument type.
Regardless of class, every autoclave must undergo regular controls: a daily Bowie-Dick or Helix test before the first load (mandatory for Class B and Class S with pre-vacuum, per ÖGSV-Leitlinie 11), chemical indicators in every load, regular biological indicators (spore tests with Geobacillus stearothermophilus), a weekly vacuum leak test (Class B), and maintenance per the manufacturer's instructions. Annual performance qualification per ÖNORM EN ISO 17665-1 is best practice. For details on mandatory controls, see the biological controls guide.
Dental practices: Class B already mandatory now for Anlage 2 Category D procedures; mandatory for all existing practices by 1 May 2028 (§ 24 Abs. 3 ÖZÄK-HygV 2025). Rotary instruments (turbines, contra-angle handpieces) are hollow and must be sterilized wrapped. The standard cycle is 134 degrees C / 3 min OR 121 degrees C / 15 min (§ 20 Abs. 5 ÖZÄK-HygV 2025). Anlage 2 additionally requires machine cleaning and disinfection in an RDG for Category D.
Tattoo, piercing, and permanent makeup: Class B is the state of the art per ÖNORM EN 17169:2020 and within the framework of the § 4 ARFKMV Unbedenklichkeitsnachweis. The federal-uniform ARPTV/ARFKMV requires sterilization of reusable instruments -- Class B enables wrapping, assignment of a use-by date, and the 10-year retention of ink batch numbers required by § 5 ARPTV.
Veterinary practices: Class B recommended for all invasive instruments. Since 6 December 2022, a sterilizer or autoclave is mandatory minimum equipment under § 4 Abs. 1 Z 2 lit. h Ordinationsrichtlinie of the Österreichische Tierärztekammer (OrdiRL 2022); private veterinary clinics need both an autoclave AND a sterilizer (§ 5 Abs. 2 lit. j OrdiRL). Surgical instruments must be sterilized wrapped to maintain sterility until use. For details on load documentation requirements, see the traceability sheet guide.
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For a complete schedule of daily, weekly, monthly, quarterly, and yearly autoclave maintenance tasks, see our Autoclave maintenance guide.