EN 13060 defines three classes of small steam sterilizers. Romanian regulations under Ordinul MS nr. 1761/2021 reference this standard for dental practices. Choosing the wrong class means your instruments may not be sterilized — even if the autoclave report says the cycle passed.
The European standard EN 13060 (adopted in Romania as SR EN 13060) defines three classes of small steam sterilizers based on their ability to process different load types. Class B (Big autoclave) handles all loads: solid, wrapped, hollow, and porous instruments. Class N (Naked) handles only solid unwrapped instruments. Class S (Specified) handles specific loads defined by the manufacturer — its capabilities vary from model to model.
The fundamental difference is the vacuum system. Class B autoclaves use a fractionated pre-vacuum that evacuates air from the chamber and from internal channels of hollow instruments before injecting steam. Without this pre-vacuum, steam cannot penetrate the lumens of hollow instruments (turbines, contra-angle handpieces, cannulae) — trapped air creates unsterilized pockets.
For dental practices in Romania, Ordinul MS nr. 1761/2021 mandates sterilization in accordance with European standards. Turbines, contra-angle handpieces, and ultrasonic scaler tips are hollow instruments — only Class B guarantees steam penetration into their internal channels. The prion cycle (134°C/18 minutes) applies to all instruments in contact with at-risk tissues.
For tattoo, piercing, and permanent makeup studios, Ordinul MS nr. 1648/2024 mandates sterilization but does not specify the class — in practice, Class B is recommended whenever reusable hollow instruments are used. Class N may suffice if all instruments are solid and unwrapped, but this significantly limits practice. Penalties for non-compliance range from 1,000 to 3,000 lei (individuals) and 20,000 to 30,000 lei (legal entities).
Class N autoclaves sterilize only solid, unwrapped, non-hollow instruments. Instruments must be used immediately after the cycle — they cannot be stored in sterilization pouches. For a dental practice, this is insufficient: instruments must be wrapped to maintain sterility until use. For a tattoo studio using only solid tubes without pouches, Class N is technically acceptable — but Class B remains recommended.
Class S autoclaves have capabilities defined by the manufacturer. Some models handle wrapped loads but not hollow instruments. Others handle certain types of hollow loads. It is essential to check the exact manufacturer specifications and ensure they cover the instrument types used in your practice. When in doubt, Class B is the safe choice.
Regardless of class, every cycle must be validated. The Bowie-Dick test verifies steam penetration for Class B autoclaves — it must be performed daily before the first load. The Helix test is specifically designed to validate sterilization of hollow instruments. A failed test means the load is not sterilized, regardless of what the cycle report shows.
For details on mandatory controls, see the biological controls guide. SecuSteri tracks cycles from all autoclave brands (W&H, Melag, Euronda, Castellini, Tuttnauer, and others) — regardless of class.
Dental practice: Class B mandatory (hollow instruments, wrapped, prion cycle). Tattoo artist and piercer: Class B recommended if reusable hollow instruments are used, Class N acceptable if only solid unwrapped instruments. Permanent makeup: Class B recommended (dermograph handpieces with hollow components). Nail salon: Class B recommended if reusable metal drill bits are used.
To understand what your traceability sheet must contain after each cycle, see the traceability sheet guide.
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