Spanish sterilization protocols require triple validation: physical controls (cycle parameters), chemical controls (indicators), and biological controls (spore indicators). This guide details the different types of controls, their frequency, and documentation requirements.
Spanish sterilization standards, aligned with UNE-EN 13060, 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.
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. This is a standard requirement across all Spanish autonomous communities for any professional using a Class B autoclave.
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 sterilization register 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. If the sterilization cycle destroys them, it will destroy any other microorganism. In Spain, biological control frequency is typically set by the Consejería de Sanidad (regional health authority) of each autonomous community.
Recommended frequency: weekly as general best practice, after every new installation or autoclave repair, and whenever there is any doubt about the equipment's performance. Some autonomous communities require monthly biological controls as a minimum. 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) 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.
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 in Spain, the use of at least one chemical integrator per load is recommended. For tattoo and piercing studios, autoclave tape on every pouch is the minimum requirement under most autonomous community decrees.
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 sterilization register and must be available during Consejería de Sanidad inspections. Retention periods vary by community but are generally a minimum of 5 years for healthcare facilities.
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, see the dedicated guide.
Verify every compliance point before the inspector arrives. Enter your email and receive the checklist immediately.