Free tool · Dental offices · United States
Free sterilizer requalification record (after a failure or a repair)
A requalification record lists the test cycles run on a sterilizer after a failure, a repair, an installation or a relocation, up to its return to service. This printable sheet is free for dental offices in the United States.
What the sources say
Points from CDC's sterilizer guidance. Each line names its source.
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A steam, ETO or other low-temperature sterilizer is tested with biological and chemical indicators upon installation, when the sterilizer is relocated, redesigned, after major repair and after a sterilization failure has occurred. (CDC disinfection and sterilization guideline, 2008)
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Three consecutive empty steam cycles are run with a biological and chemical indicator in an appropriate test package or tray. (CDC disinfection and sterilization guideline, 2008)
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Each type of steam cycle used for sterilization (e.g., vacuum-assisted, gravity) is tested separately. (CDC disinfection and sterilization guideline, 2008) In a pre-vacuum steam sterilizer three consecutive empty cycles are also run with a Bowie-Dick test. (CDC disinfection and sterilization guideline, 2008)
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Do not use the sterilizer until it has been inspected or repaired or the exact reason for the positive test has been determined. (CDC, 2003 dental infection-control guidelines)
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Rechallenge the sterilizer with biological indicator tests in three consecutive empty chamber sterilization cycles after the cause of the sterilizer failure has been determined and corrected. (CDC, 2003 dental infection-control guidelines)
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The sources differ on the chamber state. CDC's 2003 dental guidelines and the 2008 guideline describe empty-chamber cycles (CDC, 2003 dental infection-control guidelines; CDC disinfection and sterilization guideline, 2008), while CDC's 2024 page for dental settings says re-challenging with spore tests in three consecutive fully loaded chamber sterilization cycles (CDC, Best Practices for Sterilization Monitoring in Dental Settings, 2024). This record does not pick for you: each row records the chamber state its cycle ran with.
The printable log
Fill it in on screen and press Print, or print it blank and write it in by hand. Nothing you type on this page is stored or sent anywhere.
Prints on one US Letter page, landscape.
Sterilizer requalification record
One sheet per sterilizer
| Reason (positive BI, repair, installation, relocation) | Date | Cycle type | Cycle no. (1-3) | Chamber state (empty / fully loaded) | BI lot and result | CI result | Bowie-Dick (pre-vacuum only) | Operator | Returned to service (date, by) |
|---|---|---|---|---|---|---|---|---|---|
Scroll the table sideways to reach every column.
The chamber state column records how each cycle actually ran; the sources differ on empty versus fully loaded, as set out above. The Bowie-Dick column is for pre-vacuum steam sterilizers only (CDC disinfection and sterilization guideline, 2008).
How to use it
Four steps, from a blank page to a signed record of the requalification.
Fill in the header
Office name, the sterilizer's label, and the month or year the sheet covers. One sheet per requalification run.
One row per test cycle
Start with the reason for the requalification, then the date, the cycle type and the cycle number (1, 2 or 3).
Record the chamber state and the indicators
Write whether the chamber ran empty or fully loaded, the BI lot and its result, and the CI result. On a pre-vacuum steam sterilizer, fill in the Bowie-Dick column too.
Close the run
After the third cycle, record the return to service with the date and the person who signed off, then file the sheet with your sterilization records.