EN 13060 defines three autoclave classes. Class B is mandated by the Royal Decree of 25/11/2005 for tattoo artists and piercers in Belgium, and recommended by CSS/HGR for all healthcare professionals.
European standard EN 13060 defines three classes of small steam sterilisers based on their ability to process different types of loads. Class B (Big autoclave) handles all loads: solid, wrapped, hollow, and porous instruments. Class N (Naked) only processes solid, unwrapped instruments. Class S (Specified) handles specific loads defined by the manufacturer — its capabilities vary between models.
The fundamental difference is the vacuum system. Class B autoclaves use a fractionated pre-vacuum that evacuates air from the chamber and internal channels of hollow instruments before injecting steam. Without this pre-vacuum, steam cannot penetrate the lumens of hollow instruments (handpieces, contra-angles, cannulae) — trapped air creates unsterilised pockets.
In Belgium, the Royal Decree of 25 November 2005 (AR 25/11/2005) explicitly mandates a Class B autoclave for tattoo and piercing studios. This is one of the strictest requirements in Europe for this sector. Hollow instruments (cannulae, tubes) require the fractionated pre-vacuum of a Class B autoclave to ensure steam penetration into their internal channels.
For dental practices, the Superior Health Council (CSS/HGR — opinions 8363 and 9682) recommends Class B for hollow instruments used in routine practice. For podiatrists, a recognised paramedical profession in Belgium (Royal Decree of 7 March 2016), the CSS recommends Class B for invasive instruments.
Class N autoclaves only sterilise solid, unwrapped, non-hollow instruments. This means instruments must be used immediately after the cycle — it is impossible to store them in pouches. For a dental practice, this is insufficient: instruments must be wrapped to maintain sterility until use. For tattoo and piercing studios in Belgium, Class N is non-compliant: the Royal Decree of 25/11/2005 specifically requires Class B.
Class S autoclaves have capabilities defined by the manufacturer. Some models process wrapped loads but not hollow instruments. Others handle certain types of hollow loads. It is essential to verify the manufacturer's exact specifications and ensure they cover the types of instruments used in your practice. When in doubt, Class B is the safe choice — and the only compliant option for tattooing and piercing in Belgium.
Regardless of class, every cycle must be validated. The Bowie-Dick test verifies steam penetration for Class B autoclaves — it should be performed daily before the first load. The Helix test is specifically designed to validate sterilisation of hollow instruments. A failed test means the load is not sterilised, regardless of what the cycle report displays.
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.
Tattoo and piercing studio: Class B mandatory (AR 25/11/2005). Dental practice: Class B recommended by the CSS (hollow and wrapped instruments). Podiatrist: Class B recommended (invasive instruments, recognised paramedical profession). Permanent makeup (dermopigmentation): Class B recommended by CSS 8719, although sterilisation is not legally mandatory. Veterinary: Class B recommended for hollow surgical instruments.
To understand what your traceability record should contain after each cycle, see the traceability sheet guide.
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