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Autoclave validation explained: HTM 01-05, daily tests and what CQC expects
Decontamination is the part of a CQC inspection where the evidence is purely documentary: either the validation reports, test logs and cycle records exist, or they do not. Here is what is actually required, who does which test, and the differences that catch out practices working across the border.
Validation, testing, servicing: three different things
The terms get used interchangeably around the practice, and they should not be.
| What it is | Who does it | When | |
|---|---|---|---|
| Validation | Formal demonstration that the steriliser performs within its specified parameters | Test engineer | At installation, then annually; after major repair |
| Operator testing | Routine checks that it is still performing between validations | Trained practice staff | Daily / weekly per guidance |
| Servicing | Maintenance to keep the machine mechanically sound | Engineer | Per manufacturer schedule |
A machine can be freshly serviced and still fail validation, and it can pass validation while a service is overdue. You need all three, and each produces its own paperwork.
What validation requires
Validation is needed for new decontamination equipment at installation and annually thereafter, and equipment should be re-validated after major repairs capable of affecting performance. This applies to washer-disinfectors as well as sterilisers.
Between validations, a record of every sterilisation cycle should be made, demonstrating the steriliser ran within its validated parameters — time, temperature and pressure — using the machine's own indicated measurements.
The operator tests
Under HTM 01-05 in England, the routine tests carried out by practice staff are:
- Automatic control test — all benchtop sterilisers.
- Steam penetration test (Helix or Bowie-Dick) — vacuum sterilisers only.
- Weekly safety and function checks per the guidance and manufacturer's instructions.
The operative word is operator. These are not engineer tasks — they need a named, trained person in the practice, and they need recording. An unrecorded test is indistinguishable from a test that never happened.
Working in Scotland? The rules are not identical. Scottish practices follow SHTM 01-05, which replaced the SDCEP Decontamination Into Practice series. It differs in specifics — notably, the sterilizer automatic control test is specified weekly rather than daily, and equipment records are retained for the lifetime of the equipment plus 25 years. If you run practices on both sides of the border, the two sites have genuinely different testing calendars.
Record keeping
| Record | England (HTM 01-05 / CQC) | Scotland (SHTM 01-05) |
|---|---|---|
| Sterilisation cycle records | Minimum two years | Lifetime of equipment + 25 years |
| Validation reports | Retain as compliance evidence | Lifetime of equipment + 25 years |
| Operator test logs | Retain as compliance evidence | Lifetime of equipment + 25 years |
CQC inspectors assess decontamination under the Safe key question, and validation records, cycle logs and washer-disinfector records are exactly what they ask to see. This is the documentary end of inspection — there is no talking around a missing log.
The obligation that sits on top: PSSR 2000
An autoclave is a pressure vessel. Independently of everything above, it falls under the Pressure Systems Safety Regulations 2000: it must be covered by a Written Scheme of Examination and examined to that schedule by a competent person.
That is a separate visit, a separate document and a separate legal basis from validation. Our guide to pressure vessel inspection covers how it works; the practical point here is that a fully validated autoclave with no current examination certificate is still non-compliant.
Where practices actually fall down
- The daily test log has gaps. Holidays, staff changes, busy mornings. The fix is a named owner and a named deputy, not good intentions.
- Cycle records exist but nobody could find them at inspection. Decide where they live — printed or digital — and keep it consistent.
- Revalidation after repair gets missed. A repair that affects performance triggers re-validation. If an engineer has been out for anything significant, ask whether re-validation is needed before the machine goes back into use.
- The washer-disinfector is forgotten. It needs validation too, and its records are asked for alongside the autoclave's.
Not sure whether your validation is current? Tell us what sterilisers and washer-disinfectors you run and when they were last validated — we will tell you where you stand and what needs booking.
Frequently asked
How often does an autoclave need validating?
At installation, then annually — and after any major repair capable of affecting performance.
Who does the daily tests?
Trained practice staff, not the engineer. They need a named owner and a written record.
How long do records need keeping?
England: minimum two years per CQC guidance. Scotland: lifetime of the equipment plus 25 years under SHTM 01-05.
Is validation the same as the pressure vessel inspection?
No. Validation proves sterilisation performance; the PSSR 2000 examination proves the vessel is safe. Both are required, separately documented.
Validation due — or overdue?
We handle decontamination equipment servicing and testing for practices across the UK, with the documentation you need for inspection. Tell us what you run and we will map out what is due when.
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