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Also called: EN 13060, Class B, Class N, Class S

Class B Autoclave vs Class N and Class S

The EN 13060 classes decide which loads your autoclave can legitimately sterilise. Here is what each class covers and how to tell them apart.

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EN 13060 at a glance

EN 13060 is the European standard for small steam sterilisers — chambers of up to 60 litres. Most tabletop autoclaves sold in Malaysia are declared against it.

ClassAir removalProven forNot proven for
BFractionated pre-vacuumWrapped, porous, hollow (lumen) and solid loads—
SVaries by makerOnly the loads the manufacturer listsAnything not listed
NPassive (steam displacement)Unwrapped solid instrumentsWrapped, porous or hollow loads

Who needs Class B

  • Dental clinics — handpieces and suction tips are hollow.
  • Any clinic that stores instruments in pouches or wraps.
  • Day-surgery, aesthetic and minor-surgery practices using cannulae or lumens.
  • Practices whose infection-control policy requires documented air-removal tests.

Checks to ask for

  • The model’s declaration of conformity to EN 13060 and its class.
  • Built-in Bowie-Dick or helix test and vacuum leak test programmes.
  • Cycle printout or data logging.
  • MDA registration number for the Malaysian market.

Frequently asked questions

Is Class B always better than Class N?
For wrapped or hollow loads, yes — only Class B is proven for them. For unwrapped solid instruments used straight away, a Class N unit can be adequate and costs less.
How do I know an autoclave is really Class B?
Ask for the manufacturer’s EN 13060 declaration and look for a fractionated vacuum cycle, a vacuum pump and built-in Bowie-Dick or helix tests.
Does Class B take longer?
Usually a little, because of the vacuum pulses and vacuum drying, but loads come out dry and ready to store.

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