The Standards for Dental Clinics (March 2024) require validation of the sterilisation process (Standard 5.1), cycle parameter checks once each load is completed (Standard 5.4), and completed load verification (Standard 6). For tattoo, piercing, and semi-permanent makeup studios, the Standards for Tattoo and Body Piercing (January 2025) carry the same expectation. Daily Bowie-Dick or Helix tests, regular Geobacillus stearothermophilus spore indicators, and process indicators on every package are the routine controls. EN 13060 and EN ISO 17665-1 define the technical requirements; HCSD inspections verify the documentation.
Sterilisation control operates at three complementary levels. Physical indicators are the parameters displayed by the autoclave (temperature, pressure, duration) — they confirm that the cycle ran according to the selected programme. Chemical indicators (autoclave tape, chemical integrators) change colour when exposed to sterilisation conditions. Biological indicators (spore tests) are the most reliable: they confirm that the most resistant micro-organisms have been destroyed. EN ISO 17665-1 sets out the validation framework, with chemical indicators meeting EN ISO 11140-1 and biological indicators meeting EN ISO 11138.
The Bowie-Dick test (for pre-vacuum autoclaves) or Helix test (for hollow loads) verifies steam penetration into the load. The Standards for Dental Clinics (March 2024) requires this test to be performed daily, before the first load of the day, in an empty autoclave (Standard 5.4 — cycle parameters checked once each load is completed).
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 Standards for Dental Clinics also expects weekly tests: safety checks on the door seal and door safety devices, vacuum leak tests, automatic control tests, and a Bowie-Dick or Helix test for steam penetration. These weekly tests verify the ongoing mechanical integrity of the autoclave between maintenance visits.
Biological indicators contain spores of Geobacillus stearothermophilus, the micro-organism most resistant to saturated steam. If the sterilisation cycle destroys them, it will destroy any other micro-organism.
The Standards for Dental Clinics requires regular biological controls (Standard 5.1 — validation of the sterilisation process). Best practice frequency: weekly as a minimum, after every new installation or autoclave repair, and whenever there is any doubt about the equipment's performance.
The Standards for Dental Clinics expects process indicators (autoclave tape) on every pouch. Class 1 tape does not guarantee sterilisation — 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.
The Class 6 chemical integrator is the most reliable chemical indicator: it only changes colour when all critical cycle parameters have been reached.
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 sterilisation register and must be accessible during an HCSD inspection (Standard 6 — completed load verification).
Digital traceability allows control results to be archived automatically and linked to the relevant sterilisation cycles, eliminating the risk of loss or oversight. For more details on use-by dates, 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.