The Swiss Good Practice for Medical Device Reprocessing (GPA 2022) and KIGAP 2010 (status 2017) require validation of the sterilization process and regular biological control. Daily Bowie-Dick or Helix tests before the first load, regular Geobacillus stearothermophilus spore indicators, and process indicators on every package are the routine controls. SN EN 13060 and SN EN ISO 17665-1 define the technical requirements; the Kantonsarztamt verifies the documentation during cantonal inspection.
Swiss sterilization standards — defined by the GPA 2022 (Swiss Good Practice for Medical Device Reprocessing), KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) — require a triple validation system for every autoclave. Physical indicators are the parameters displayed by the autoclave itself (temperature, pressure, duration) — they confirm that the cycle ran according to the selected program. Chemical indicators (autoclave tape, chemical integrators) change color when exposed to sterilization conditions. Biological indicators (spore tests) are the most reliable: they confirm that the most resistant microorganisms have been destroyed.
Each level provides a different type of assurance. Physical indicators confirm the machine operated correctly. Chemical indicators confirm that sterilization conditions reached the instruments inside the pouches. Biological indicators confirm that sterilization was actually achieved at a microbiological level. All three levels are necessary — no single indicator is sufficient on its own. For dental practices, MePV / ODim Art. 71 and 72 set the regulatory baseline, with practice-level reprocessing inspection by the Kantonsarztamt / Service du médecin cantonal; for tattoo, piercing, and permanent makeup studios, Art. 62 LGV and the EDI Ordinance on objects in human contact (SR 817.023.41) Art. 4 to 7 set the hygiene obligations.
The Bowie-Dick test (for pre-vacuum autoclaves) or Helix test (for hollow loads) verifies steam penetration into the load. It must be performed daily, before the first load of the day, in an empty autoclave. SN EN 13060 establishes this as a requirement for Class B and Class S autoclaves with pre-vacuum cycles; SN EN ISO 17665-1 frames the thermal validation regime.
A failed Bowie-Dick test indicates a steam penetration problem — it could be a leak, a vacuum pump issue, or a worn gasket. The autoclave must not be used until the problem is resolved. The test result (pass or fail) must be recorded in the load documentation along with the date and any corrective action taken.
The vacuum leak test verifies that the autoclave maintains the vacuum required during the pre-vacuum phase of the cycle. A leak compromises steam penetration — instruments at the center of the load may not be sterilized. This test is recommended weekly and mandatory after any maintenance on the vacuum system.
The door seal (gasket) should also be checked regularly. A worn or damaged seal causes steam leaks, failed cycles, and premature wear on the vacuum pump. SecuSteri allows you to record the results of all these checks (vacuum test, seal check, Bowie-Dick, Helix, biological indicators) directly in the digital register, linked to the day and the autoclave concerned.
Biological indicators contain spores of Geobacillus stearothermophilus, the microorganism most resistant to saturated steam per SN EN ISO 11138. If the sterilization cycle destroys them, it will destroy any other microorganism. They are the definitive proof that sterilization was effective.
Recommended frequency by risk profile and cycle volume: KIGAP recommends a weekly to monthly cadence depending on risk analysis, after every new installation or autoclave repair, and whenever there is any doubt about the equipment's performance. The GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018) emphasize the importance of qualified personnel (sterilization as a core competency for dental assistants Dentalassistentin EFZ and dental hygienists Dentalhygienikerin HF) for the correct execution and evaluation of biological controls. After any failed biological test, the autoclave must be taken out of service until the cause is identified and resolved, and all instruments processed since the last successful test must be considered non-sterile.
Autoclave tape (Class 1 indicator per SN EN ISO 11140-1) is placed on each pouch. It does not guarantee sterilization — it merely indicates that the pouch has been through the autoclave. Chemical integrators (Class 4, 5, or 6) provide more thorough verification by measuring exposure to temperature, pressure, and time simultaneously.
The Class 6 chemical integrator is the most reliable chemical indicator: it only changes color when all critical cycle parameters have been reached. For dental practices with high instrument volume, the use of Class 5 or 6 integrators in every load is recommended practice per the GPA 2022 and the SSO Quality Guidelines on Practice Hygiene (2018).
Every biological and physico-chemical control must be documented: date, type of test, result (pass / fail), and any corrective action taken. These records are an integral part of the load documentation. Switzerland has no codified retention period in MePV; the GPA 2022 and KIGAP recommend alignment with SN EN 868 (packaging) and SN EN ISO 11607 (packaging validation) plus long-term archival for civil-liability purposes. During a Kantonsarztamt / Service du médecin cantonal inspection or a cantonal enforcement check, all records must be available for immediate review.
Digital traceability allows control results to be archived automatically and linked to the relevant sterilization cycles, eliminating the risk of loss or oversight. For more details on use-by dates for sterilized instruments, see the dedicated guide.
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For a complete schedule of daily, weekly, monthly, quarterly, and yearly autoclave maintenance tasks, see our Autoclave maintenance guide.