EN 13060 defines three classes of small steam sterilizers. Choosing the wrong class means your instruments may not be sterilized — even if the autoclave report says the cycle passed. This guide explains the differences and the legal requirements in France.
The European standard 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.
In France, Class B has been mandatory for dental practices since Circular DGS/DH n°236 of 2 April 1996. 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 min), mandated by the 2001 circular, also requires a Class B autoclave.
For podiatrists, the ONPP (Ordre National des Pédicures-Podologues — podiatry regulatory body) recommends Class B for hollow instruments used in invasive procedures. For tattoo artists and piercers, the 2008 decree requires sterilization but does not specify the class — in practice, Class B is strongly recommended whenever reusable hollow instruments are used. Class N may suffice if all instruments are solid and unwrapped, but this significantly limits practice.
Class N autoclaves sterilize only solid, unwrapped, non-hollow instruments. This means instruments must be used immediately after the cycle — they cannot be stored in 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). Podiatrist: Class B recommended (hollow instruments in invasive procedures). 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). Veterinary: Class B recommended for hollow surgical instruments.
To understand what your traceability sheet must contain after each cycle, see the traceability sheet guide.
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