HTM 01-05 requires that every sterilisation cycle record demonstrates the steriliser is working within validated parameters — time, temperature, and pressure. Records must identify the machine, the operator, the date, and the test results. This guide details the required fields and how a digital system generates compliant records automatically.
HTM 01-05 requires a record of every sterilisation cycle demonstrating that the steriliser is working within validated parameters. Every machine must have its own dedicated logbook. Records must be kept for a minimum of 2 years. However, HTM 01-05 does not prescribe a specific record form — the obligation is to demonstrate that every cycle was properly run, validated, and linked to the instruments processed. For tattoo, piercing, and podiatry practitioners, structured traceability records are essential evidence of compliance with registration, licensing, or professional standards.
For full details on regulatory requirements, see the sterilisation regulations guide.
Based on HTM 01-05 requirements, a sterilisation traceability record should include: the date and time of the cycle, machine identification, cycle number or batch number, cycle type and programme used, recorded parameters (temperature, pressure, duration), cycle result (pass or fail), the identity of the operator who loaded and validated the cycle, and the instruments or pouches included in the load.
For dental practices, HTM 01-05 also expects documentation of daily Helix or Bowie-Dick test results (before the first load), periodic vacuum leak and safety device checks, and regular biological control results. HTM 01-05 explicitly warns that autoclave thermal printouts may fade over time — a digital record eliminates this risk entirely. For details on use-by dates, see the sterilisation use-by date guide.
Dental practices have the most detailed expectations: HTM 01-05 requires dedicated logbooks per machine, and the CQC assesses record quality under Regulation 12. CQC prosecutions have increased 50% post-pandemic, with Regulation 12 the most commonly prosecuted regulation. For podiatrists, HCPC registration creates professional accountability — sterilisation records are best practice for invasive procedures. For tattoo and piercing studios, council registration (England, Northern Ireland), licensing (Wales, Scotland), and BS EN 17169:2020 all expect documented sterilisation practices. In Wales, the mandatory licensing scheme under the Public Health (Wales) Act 2017 requires demonstrable infection prevention and control compliance.
HTM 01-05 requires sterilisation records to be kept for a minimum of 2 years. However, general healthcare best practice suggests retaining records for longer — at least the period during which a patient complaint, CQC investigation, or GDC fitness to practise proceeding could be brought. Most dental practices retain sterilisation records for a minimum of 8 years (aligning with patient record retention guidance). For other professions, a minimum of 5 years is prudent.
Paper records are the traditional approach, but they are vulnerable to loss, damage, and illegibility. HTM 01-05 warns that autoclave thermal printouts may fade over time and recommends photocopying them. CQC inspection reports have flagged incomplete records as a concern in dental practices. A digital system generates the traceability record automatically from the autoclave report, links instruments to patients, and makes every record searchable and instantly accessible — exactly what an inspector expects to see.
For a detailed comparison between paper and digital registers, see our digital register guide.
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