Everything you need to know about keeping your autoclave compliant – daily tests, annual validation, PSSR inspections, and what CQC actually looks for.
If you run a dental, veterinary, or podiatry practice in the UK, your autoclave isn’t just another piece of equipment – it’s the backbone of your infection control process. And the rules governing how you maintain and validate it aren’t optional. They’re a legal requirement.
Yet we visit practices every week where the team isn’t fully clear on what HTM 01-05 actually requires, what the difference is between servicing and validation, or why a Pressure Vessel Inspection matters. This guide breaks it all down in plain English so you know exactly what’s expected of you – and how to stay ahead of your next CQC inspection.
HTM 01-05 — Health Technical Memorandum 01-05 – is the Department of Health’s guidance document for decontamination in primary care settings, including dental practices. It sets out best practice for cleaning, disinfecting, and sterilising reusable instruments.
While it was originally written with dentistry in mind, it’s widely adopted as the benchmark for any primary care environment that reprocesses instruments, including veterinary surgeries and podiatry clinics. The CQC references HTM 01-05 directly in its inspection framework, and compliance with it is effectively mandatory for anyone registered with the CQC.
The guidance covers the full decontamination workflow – from manual cleaning and ultrasonic baths through to washer disinfectors and, critically, steam sterilisation in autoclaves. It specifies the testing, maintenance, and validation schedules you need to follow and the records you need to keep.
This is one of the most common areas of confusion, and it’s an important distinction.
Servicing is a mechanical and electrical check of your autoclave. A qualified engineer inspects internal components, replaces worn parts, checks seals and gaskets, tests safety systems, and confirms the machine is in good working order. Think of it as a car MOT for the machine itself.
Validation goes further. It proves that your autoclave is actually achieving sterilisation throughout the entire chamber. Using calibrated temperature probes and data loggers, a validation engineer maps the temperature distribution inside the chamber during a live cycle. Biological indicators are used alongside this to confirm that the conditions are lethal to all microorganisms.
In other words, servicing confirms the machine works. Validation proves it sterilises effectively. You need both.
HTM 01-05 requires both an annual service by a competent engineer and annual validation testing. Many practices combine these into a single visit to reduce disruption.
Under current UK regulations, there are three separate compliance elements your autoclave needs every year:
Annual validation by an engineer is only one piece of the puzzle. HTM 01-05 also requires practices to carry out their own routine tests throughout the year:
Daily Tests
Every morning before your first sterilisation cycle, you should run an Automatic Control Test (ACT). This tests the autoclave’s operating parameters — temperature, pressure, and timing. The results should be checked, printed or recorded, and signed off by the designated user before the autoclave is released for clinical use.
For vacuum autoclaves (Class B and some Class S), a daily steam penetration test (such as a Bowie-Dick or Helix test) should also be run on an empty chamber first thing. This confirms that the vacuum system is removing air effectively.
Weekly Tests
Residual air and air leakage tests should be carried out weekly on vacuum autoclaves. These detect faults in the vacuum system that might not be caught by the daily steam penetration test.
Your ultrasonic bath also requires weekly protein residue testing and regular water changes. The washer disinfector needs a weekly protein residue test on a processed instrument.
Quarterly Tests
Washer disinfectors require a cleaning efficacy test using a Process Challenge Device (PCD) and Chemical Efficacy Indicator (CEI) every quarter. Ultrasonic baths need a quarterly activity test to confirm they are producing sufficient cavitation energy.
Record Keeping
All test results – daily, weekly, and quarterly – must be recorded in a log book and signed by the designated user. HTM 01-05 is clear that these records should be kept both as hard copies and ideally as digital backups. CQC inspectors will ask to see these records, and gaps in your testing log are a red flag.
The CQC assesses practices against five key questions: Safe, Effective, Caring, Responsive, and Well-Led. Decontamination falls squarely under “Safe.”
During an inspection, the clinical inspector will typically observe your decontamination room and process in person. Here’s what they’re looking for:
Documentation they’ll ask to see:
Physical checks they’ll make:
Questions they may ask staff:
HTM 01-05 distinguishes between three classes of benchtop autoclave, and the class you use matters for compliance:
Class B (vacuum) — The recommended choice for most practices. Uses pre- and post-vacuum cycles to ensure complete air removal. Can sterilise hollow instruments (like handpieces), wrapped instruments, porous loads, and items in pouches. If your practice processes any of these load types, Class B is the expected standard.
Class S (specific) — A middle-ground option. Some Class S machines have a vacuum phase, but it may not be sufficient for all load types. Check with your supplier whether your specific model is validated for the instruments you process.
Class N (non-vacuum) — The simplest type. Suitable only for unwrapped, solid instruments. Cannot sterilise hollow items, wrapped loads, or pouched instruments. Most modern practices find a Class N autoclave too restrictive.
After thousands of service visits across UK practices, here are the issues we encounter most frequently:
The short answer: once a year for the full package (service + PVI + validation), with an additional service visit at the six-month mark if your manufacturer recommends it.
We recommend booking four to six weeks in advance for a standard appointment, ideally on a quieter day for the practice to minimise disruption. If you’re a new practice, have recently acquired a used autoclave, or have changed your sterilisation workflow, book a validation as soon as possible.
At GQ Decontamination, we send automated reminders when your annual service and validation are due, so you never have to worry about falling out of compliance.
Standard | Description |
HTM 01-05 | Decontamination in primary care dental practices |
PSSR 2000 | Pressure Systems Safety Regulations (HSE) |
PUWER 1998 | Provision and Use of Work Equipment Regulations |
BS EN ISO 13060:2014 | Small steam sterilisers |
BS EN ISO 15883 | Washer disinfectors |
BS EN ISO 17665 | Sterilisation of health care products — moist heat |
Whether you’re overdue for validation, setting up a new practice, or simply want the reassurance of knowing everything is compliant, our engineers are here to help. We service and validate all major autoclave brands — including MOCOM, W&H, MELAG, Eschmann, SciCan, NSK, and more — and our validation testing uses calibrated equipment with UKAS-traceable certification.
One visit. Full compliance. Complete peace of mind.
Call us on 01274 265566
hello@gqdecontamination.co.uk | gqdecontamination.co.uk/contact
GQ Decontamination provides HTM 01-05 compliant servicing, validation, and pressure vessel inspections for dental, veterinary, and podiatry practices across the UK. Based in West Yorkshire with nationwide coverage.
