Autoclave class B, N, S in Switzerland: which one does your practice need?

SN EN 13060 defines three classes of small steam sterilizer. KIGAP 2010 (status 2017) recommends Class B (small / portable / bench-top) for hollow-lumen instruments and wrapped loads — the standard in dental practice and surgical podiatry. Class N and Class S sterilizers cannot reliably process hollow-lumen instruments. Thermal validation follows SN EN ISO 17665-1; washer-disinfectors follow SN EN ISO 15883. For tattoo, piercing, and permanent makeup studios, Class B is the practical standard for any reusable instruments alongside single-use sterile needles and cartridges.

The three SN EN 13060 classes

SN EN 13060 classifies small steam sterilizers into three classes based on their steam penetration capability and the load types they can process. This classification determines which instruments each autoclave can sterilize and, therefore, which class is appropriate for each profession. In Switzerland, the GPA 2022 (Swiss Good Practice for Medical Device Reprocessing), KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) define state-of-the-art compliance. Instrument risk classification follows the Spaulding system (critical / semi-critical / non-critical).

Class B: the standard for practices and studios

Class B (Big autoclave, small sterilizer) is the most versatile class. It features a fractionated pre-vacuum system that evacuates air from the chamber and from the internal channels of hollow instruments (dental turbines, contra-angle handpieces, cannulae) before steam injection. Only Class B can reliably sterilize wrapped loads, hollow instruments, and textiles.

KIGAP 2010 (status 2017) recommends Class B (small / portable / bench-top) for hollow-lumen instruments and wrapped loads — the standard in dental practice and surgical podiatry. A washer-disinfector (RDG) per SN EN ISO 15883 is state of the art for higher-volume practices. The GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018) recommend Class B as the standard for all dental practices. For tattoo studios using hollow instruments, Class B is likewise the state of the art under the EDI Ordinance on objects in human contact (SR 817.023.41) and SN EN 17169:2020 (Tattooing — Safe and Hygienic Practice).

Class N: limited to solid unwrapped instruments

Class N (Naked) can only process solid, unwrapped, non-hollow instruments. There is no pre-vacuum — air displacement occurs by gravity, which is insufficient for hollow instruments or wrapped loads. Instruments sterilized in a Class N autoclave must be used immediately after the cycle, as they lose sterility upon contact with ambient air without packaging.

In Swiss practice, Class N has very limited application: it does not allow sterilization of wrapped instruments, cannot process hollow instruments, and does not provide the traceability expected under the GPA 2022 and MePV / ODim Art. 72. Packaging per SN EN 868 and SN EN ISO 11607 is not possible with Class N, since no use-by date can be assigned to an unwrapped instrument. Its use is restricted to immediate sterilization of emergency instruments.

Class S: per manufacturer specifications

Class S (Specified) is an intermediate category defined by the manufacturer's specifications. The manufacturer declares which load types their Class S autoclave can process (e.g., "solid wrapped instruments" or "hollow type A instruments"). The available cycles and permitted loads vary from model to model — there is no single standard for Class S.

Before purchasing a Class S autoclave, it is essential to verify that the manufacturer's declared cycles cover the specific requirements of your practice. When in doubt, Class B is always the safest choice: it covers all load types and matches the recommendation of KIGAP and the GPA 2022.

How to verify your autoclave is working correctly

Regardless of class, every autoclave must undergo regular controls: a daily Bowie-Dick or Helix test before the first load (mandatory for Class B and Class S with pre-vacuum), chemical indicators in every load per SN EN ISO 11140-1, regular biological indicators (spore tests with Geobacillus stearothermophilus per SN EN ISO 11138), a weekly vacuum leak test (Class B), and maintenance per the manufacturer's instructions. Annual performance qualification per SN EN ISO 17665-1 is best practice. For details on mandatory controls, see the biological controls guide.

Summary by profession

Dental practices: Class B as the de facto standard per KIGAP and the GPA 2022 for hollow-lumen instruments and wrapped loads. Rotary instruments (turbines, contra-angle handpieces) are hollow and must be sterilized wrapped. The standard cycle is 134°C / 5.5 min; for prion-relevant procedures, CJKV (SR 818.101.21) prescribes the 134°C / 18-minute cycle.

Tattoo, piercing, and permanent makeup: Class B as the practical standard per SN EN 17169:2020 and the EDI Ordinance on objects in human contact (SR 817.023.41) Art. 4 to 7. Class B enables wrapping and use-by date assignment, and covers hollow-lumen and reusable instruments.

Veterinary practices: Class B recommended for all invasive instruments. In Switzerland there is no federal autoclave mandate — KIGAP explicitly does NOT name veterinary practices among its user groups. The GST Code of Professional Conduct 2022 and the BLV / OSAV framework apply as the professional standard; Class B remains the quality-appropriate choice to preserve sterility until use. For details on load documentation requirements, see the traceability sheet guide.

Free Inspection Checklist

Verify every compliance point before the inspector arrives. Download the PDF instantly — no email required.

For a complete schedule of daily, weekly, monthly, quarterly, and yearly autoclave maintenance tasks, see our Autoclave maintenance guide.