Every dental practice in Switzerland must have a written hygiene and sterilization protocol — the implicit expectation of MePV Art. 71/72 and the GPA 2022. The Kantonsarztamt verifies both the documentation and its implementation. The protocol must cover the sterilization chain, the validation regime, the cycle and load verification steps, staff training records, and — for prion-relevant procedures — the 134°C / 18-minute cycle per CJKV (SR 818.101.21). This guide details what your protocol must contain and what cantonal inspectors look for.
In Switzerland, every dental practice must maintain a written hygiene and sterilization protocol that describes the reprocessing of medical devices in detail. This is the implicit expectation of MePV / ODim Art. 71 and 72 (SR 812.213) and the GPA 2022 (Swiss Good Practice for Medical Device Reprocessing). The SSO Quality Guidelines on Practice Hygiene (2018) define the requirements for members of the Swiss Dental Society; KIGAP 2010 (status 2017) provides the technical foundation. The plan must be accessible to all staff and available for presentation during a Kantonsarztamt / Service du médecin cantonal reprocessing inspection. The hygiene plan is not a simple poster on the wall — it is an operational document that describes how, when, and who performs each step.
Its absence or insufficiency is one of the most common findings during inspections. Compliance with recognized standards (SN EN 13060, SN EN ISO 15883, SN EN ISO 17665-1, SN EN 868, SN EN ISO 11607) is the prerequisite for proper reprocessing. Complete documentation is the foundation of every cantonal inspection — not "we assume it is proper," but a demonstrable reprocessing practice. Switzerland has no codified retention period in MePV; the GPA 2022 and KIGAP recommend long-term archival for civil-liability purposes.
The designation of the medical-device reprocessing supervisor, including proof of expertise (sterilization as a core competency for dental assistants Dentalassistentin EFZ and dental hygienists Dentalhygienikerin HF per SBFI / GPA 2022 / SSO Quality Guidelines on Practice Hygiene 2018). A detailed description of each step in the reprocessing chain (pre-cleaning, machine cleaning and disinfection in a washer-disinfector per SN EN ISO 15883, rinsing, drying, inspection, packaging per SN EN 868, sterilization, release, storage). The products used at each step (trade name, concentration, contact time). The autoclave sterilization parameters (Class B per SN EN 13060 per KIGAP recommendation; program, temperature, pressure, hold time — standard cycle 134°C / 5.5 min; prion-relevant cycle 134°C / 18 min per CJKV, SR 818.101.21). The frequency and type of controls (daily Bowie-Dick / Helix test, chemical indicators per SN EN ISO 11140-1 in every load, regular biological indicators with Geobacillus stearothermophilus per SN EN ISO 11138). Instrument risk classification per Spaulding (critical / semi-critical / non-critical). The procedure in case of a failed cycle or non-compliant test. The autoclave maintenance schedule. Instrument-specific reprocessing instructions per SN EN ISO 17664 (manufacturer information).
The hygiene plan must be updated when a product, device, or procedure changes. Each update must be dated and signed by the responsible person. The GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018) expect a written hygiene and sterilization plan without a prescribed minimum format — completeness and implementability are what counts.
For a step-by-step breakdown of the reprocessing chain, see our dental reprocessing chain guide.
A cycle is valid when the recorded parameters match the selected program and all indicators are compliant. The GPA 2022 accepts electronic storage of process data as equivalent to paper printout, provided integrity, completeness, and availability during inspection are guaranteed. The autoclave must be Class B per SN EN 13060 to sterilize hollow instruments (turbines, contra-angles) and wrapped loads — this is the KIGAP recommendation and the de facto standard in Swiss dental practice. 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.
Before the first load of each working day, a Bowie-Dick test or Helix test validates proper autoclave function. Hollow instruments (turbines, contra-angles) require the Helix test to validate steam penetration into channels. A failed cycle or a non-compliant indicator requires repackaging and resterilization of the entire load. Annual performance qualification per SN EN ISO 17665-1 is best practice.
For details on biological controls, see our autoclave biological controls guide.
The Kantonsarztamt / Service du médecin cantonal has performed practice-level reprocessing inspection of Swiss dental practices since 1 July 2011 under MePV / ODim Art. 71 and 72. Inspections can be scheduled (as part of the regular inspection calendar) or unannounced (following complaints or hygiene incidents). The inspector checks: the existence of the hygiene plan, its compliance with the GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018), that staff know and follow it, that reprocessing documentation is complete and up to date, that periodic controls (Bowie-Dick, biological controls) are performed as documented, and that the Spaulding classification of instruments (critical / semi-critical / non-critical) is correctly applied.
The Swiss Dental Society (SSO) can also conduct quality reviews and handles disciplinary proceedings for its members. In case of repeated or serious findings, the Cantonal Health Directorate may suspend or revoke the cantonal practice license under MedBG / LPMéd (SR 811.11). The most frequently flagged issues during inspections: missing instrument-to-patient traceability, absent or incomplete hygiene plan, undocumented biological controls, and insufficient qualification of the person responsible for reprocessing.
The hygiene plan must define the traceability method used. The paper register remains legally accepted, but its limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-patient link, risk of loss in case of disaster. Switzerland has no codified retention period in MePV; the GPA 2022 and KIGAP recommend alignment with SN EN 868 and SN EN ISO 11607 plus long-term archival for civil-liability purposes. The SSO Quality Guidelines on Practice Hygiene (2018) envision a multi-year horizon.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a signed, tamper-proof record. Each cycle is archived according to the plan's retention period, accessible at any time during an inspection.
For a detailed comparison, see our digital vs paper register guide.
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