NF EN 13060 and EN ISO 17665-1 define the requirements for sterilization cycle validation, including steam penetration tests (Bowie-Dick, Helix) and regular biological controls (Geobacillus stearothermophilus spore indicators). In Luxembourg, these controls form part of the general professional duty and may be verified by the Inspection sanitaire for dental practices, and by officers of police judiciaire for tattoo / piercing / permanent makeup studios (Loi du 24 mai 2018). This guide details the expected frequency and documentation.
Sterilization 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 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 micro-organisms have been destroyed.
The Bowie-Dick test (for pre-vacuum autoclaves) or the Helix test (for hollow loads) verifies steam penetration into the load. It should be performed daily, before the first load of the day, in an empty autoclave. NF EN 13060 and EN ISO 17665-1 define the requirements for these tests.
A failed Bowie-Dick test indicates a steam penetration problem — it could be a leak, a vacuum pump issue, or a worn seal. The autoclave should not be used until the problem is resolved.
The vacuum leak test verifies that the autoclave maintains the necessary vacuum 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 is mandatory after any maintenance on the vacuum system.
The door seal 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 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 micro-organism most resistant to saturated steam. If the sterilization cycle destroys them, it will destroy any other micro-organism. The reference standard is EN ISO 11138 for biological indicators.
Recommended frequency varies by guideline: weekly as general best practice, after every new installation or autoclave repair, and whenever there is any doubt about the equipment's functioning. NF EN 13060 and EN ISO 17665-1, together with European sector best practice, recommend regular biological controls as part of the ongoing validation of the sterilization process.
Autoclave tape (Class 1 indicator, per EN ISO 11140-1) is placed on each pouch. It does not guarantee sterilization — it only indicates that the pouch has been through the autoclave. Chemical integrators (Class 4, 5, or 6) offer a 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 color when all critical cycle parameters have been reached.
Every biological and physico-chemical control must be documented: date, test type, result (pass/fail), and corrective action if applicable. These documents are an integral part of the sterilization register. In Luxembourg, tattoo, piercing, and permanent makeup studios are subject to inspections by officers of police judiciaire in liaison with the Inspection sanitaire (Loi du 24 mai 2018) — control results are among the elements verified. In dental practice, the Inspection sanitaire (Direction de la santé) may verify these same elements as part of the general professional duty of hygiene.
Digital traceability automatically archives control results and links them to the relevant sterilization cycles, eliminating the risk of loss or omission. For more details on the use-by date, 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.