EN 13060 defines three classes of small steam sterilisers. The Dental Council's IPC Code references this standard directly. Choosing the wrong class means your instruments may not be sterilised — even if the autoclave report says the cycle passed.
The European standard EN 13060 defines three classes of small steam sterilisers 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 unsterilised pockets.
The Dental Council's IPC Code references EN 13060 directly and requires that autoclaves used in dental practices are capable of sterilising all load types encountered in practice — including wrapped and hollow instruments. In practice, this means Class B. The HSE's LDU Standards (2012) reinforce this by specifying decontamination procedures for handpieces and hollow instruments that require pre-vacuum cycles.
The IPC Code also states that unwrapped instruments must be used on the day of sterilisation — storage of unwrapped instruments is not allowed. This effectively eliminates Class N for any practice that needs to store sterilised instruments, which is virtually all dental practices.
Class N autoclaves sterilise only solid, unwrapped, non-hollow instruments. Instruments must be used immediately after the cycle — they cannot be stored in pouches. For dental practices, this is insufficient under the IPC Code. For tattoo or piercing studios using only solid instruments without pouches, Class N may be technically acceptable as a minimum, though Class B remains the professional standard.
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.
The IPC Code requires daily Bowie-Dick or Helix tests before the first load. The Bowie-Dick test verifies steam penetration for Class B autoclaves. The Helix test is specifically designed to validate sterilisation of hollow instruments. Weekly tests — vacuum leak, door seal, and automatic control checks — are also required. A failed test means the load is not sterilised, regardless of what the cycle report shows.
For details on testing requirements, 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 required in practice under the IPC Code (hollow instruments, wrapped storage). Podiatrist: Class B recommended for invasive procedures with hollow instruments. Tattoo artist and piercer: Class B recommended as best practice, Class N minimum if only solid unwrapped instruments. Permanent makeup: Class B recommended (handpieces with hollow components).
To understand what your traceability record should contain after each cycle, see the traceability sheet guide.
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