Autoclave testing requirements for a dental practice in England come in three layers: routine tests by your own team, validation at installation and every year after that, and a separate pressure vessel safety examination. HTM 01-05 sets out a recommended schedule of daily, weekly, quarterly and annual tests.
HTM 01-05 is guidance for dental practices in England, and it calls these machines sterilizers. Autoclave and steriliser mean the same thing here.
How often should an autoclave be tested?
CQC says equipment should be validated, tested, maintained and serviced as recommended by the manufacturer, and that in the absence of the manufacturer’s instructions, the periodic tests and schedules can be found in HTM 01-05. So check your machine’s manual first, then use the table below.
The recommended testing protocol in HTM 01-05 is:
| When | Test | Steriliser type | Done by |
|---|---|---|---|
| Daily | Steam penetration | B, S | User or operator |
| Daily | Automatic control test | B, N, S | User or operator |
| Weekly, plus daily tests | Air leakage | B, S | User or operator |
| Weekly, plus daily tests | Residual air test | S, N | User or operator |
| Quarterly, or to manufacturer’s recommendations, plus weekly tests | Thermometric tests | B, N, S | Competent Person (Decontamination) or service engineer |
| Annually, plus quarterly tests | Steam generator overheat cut-out test | B, N, S | Competent Person (Decontamination) or service engineer |
| Annually, plus quarterly tests | Thermometric tests, small and large load | B, N, S | Competent Person (Decontamination) or service engineer |
| Annually, plus quarterly tests | Dryness tests, small and large load | B, S | Competent Person (Decontamination) or service engineer |
If you are not sure which type you have, ask your service engineer to confirm.
What the daily tests involve
HTM 01-05 says the daily tests should be carried out by the operator or user and will normally consist of:
- a steam penetration test, using a Helix or Bowie-Dick test, for vacuum sterilisers only
- an automatic control test, for all benchtop sterilisers, in line with the manufacturer’s instructions
- a record of the temperature and pressure achieved, to confirm it is satisfactory before the autoclave is used for instruments
Before the daily tests, the user should clean the door seal with a clean, damp, non-linting cloth, check the chamber and shelves for cleanliness and debris, and fill the reservoir with distilled or reverse osmosis water. The outcomes should go in the logbook with the date and the operator’s signature.
If a test fails
HTM 01-05 says a steriliser that fails to meet any of the test requirements should be withdrawn from service, and advice sought from the manufacturer or maintenance contractor. Any instruments processed in an unsuccessful cycle should not be used.
Dental autoclave validation
Validation shows that the machine actually reaches the temperature, pressure and time needed to sterilise. HTM 01-05 says validation is needed for new equipment at installation and annually thereafter, and also after any major repairs.
A Competent Person (Decontamination) or service engineer will be able to make sure validation is achieved. CQC repeats the installation and annual requirement in its mythbuster on validation, and treats validation of decontamination equipment as part of whether a practice is safe, relating to Regulation 15 and Regulation 12.
The pressure vessel examination is separate
Sterilisers are pressure vessels, and validation does not replace this check. CQC says a suitable written scheme of examination needs to be in place for each one, and that sterilisers then need to be examined in accordance with it. CQC says the maximum interval between these inspections is 14 months, and that current certification must be available for inspection. The legal duty is to have the examination done within the interval set in your written scheme, which a competent person decides, so check what yours says.
HTM 01-05 confirms that all steam sterilisers are subject to the Pressure Systems Safety Regulations 2000 and must be examined periodically by a Competent Person (Pressure Vessels). Arrange this with a Competent Person (Pressure Vessels) and keep the certificate. Do not assume a routine service visit has covered it. Our page on the pressure vessel inspection has more on what to keep.
What records you need
Each steriliser should have a logbook recording maintenance, validation, faults, modifications and routine tests.
CQC says a record of every single sterilisation cycle should be made, showing that the machine is working within validated parameters such as time, temperature and pressure. Records need to be kept for a minimum of two years.
If the machine has an automatic printer, HTM 01-05 says to retain the print-out or copy it to a permanent record. Without a printer, the user has to record the date, satisfactory completion of the cycle, the temperature and pressure achieved, and their signature. CQC lists data loggers, with copies stored on a computer, as best practice.
Keeping on top of it
Simple gaps are easy to miss, such as a skipped weekly test, a logbook that stops during holiday cover, or an expired certificate. Give one named person responsibility for each machine, and see our HTM 01-05 guide for how this fits with your washer-disinfector and ultrasonic checks.
Your Competent Person (Decontamination) or service engineer should make the call on anything specific to your machine.
In Compliance UK, each piece of equipment gets a QR label that opens a one-screen log on a phone, including autoclave daily tests and annual validation reminders.
Sources
- NHS England: HTM 01-05, decontamination in primary care dental practices
- CQC: Dental mythbuster 12, validation of decontamination equipment
Sources checked on 10 November 2026.