Class B Autoclave: Regulatory Requirements and Maintenance

Why standard EN 13060 makes the Class B autoclave the only suitable choice for the dental practice, and how to plan maintenance that preserves its reliability over time.

The reference technical standard for small steam sterilizers used in dental practices is EN 13060, which distinguishes three classes — N, S and B — based on air removal capability and the types of load the device can process. Class N autoclaves ("naked solid products") only handle loose solid instruments and aren't suitable for porous materials, pouched items or hollow bodies like turbines and handpieces, because they don't ensure proper steam penetration into these complex geometries. Class S autoclaves cover a middle ground not standardized by the norm, with characteristics defined by the individual manufacturer.

Class B autoclaves are the only ones equipped with a fractionated vacuum system: before starting the cycle, the chamber is emptied and refilled multiple times in sequence, eliminating even microscopic air bubbles trapped in cavities and porosities of the instruments. Only this way can steam reach every internal and external surface of the device, including the hollow cannulas of turbines and contra-angles. For this reason, Class B is, in practice, the only viable choice in a dental practice: it handles solid, porous, pouched and hollow-body loads indiscriminately, with performance comparable to a hospital installation despite its compact format.

Maintaining an autoclave isn't an optional that can be postponed: it's equipment that works daily under pressure and high temperatures, and is subject to natural wear of seals, valves and the vacuum pump. A scheduled maintenance plan typically includes periodic descaling (essential if the feed water isn't adequately demineralized, since limescale is among the main causes of pump failure), replacing the door seal, checking solenoid valves, and verifying temperature and pressure sensors. The manufacturer sets the frequency of these interventions in the machine's manual, to be performed by qualified technical personnel.

Alongside routine maintenance, the standard requires a system of routine checks to verify that each cycle actually achieved sterility conditions: the daily vacuum test checks chamber vacuum-tightness, the Bowie-Dick test (typically performed every two weeks) checks steam penetration capability in porous loads, and the Helix test specifically checks penetration into hollow bodies. These physical checks complement, but don't replace, the chemical and biological tests that verify the actual sterilization outcome instrument by instrument.

On Oralzon you'll find Class B autoclaves certified to EN 13060 in various capacities (from 12 to over 25 liters), along with all the consumables for routine tests and maintenance kits.