HTM 01-05 is the guidance UK dental practices are measured against for decontamination and sterilisation, and it comes up in nearly every CQC infection control conversation. Here is what practice managers actually need to know, without the full document.
What HTM 01-05 covers
The guidance sets out requirements for decontaminating reusable dental instruments, covering cleaning, disinfection, sterilisation, storage, and traceability. It applies to how instruments move from a used state through to being safely reused on the next patient, and it is the reference point CQC inspectors use when assessing a practice's decontamination processes.
The practical requirements that matter day to day
- Instruments must be cleaned before sterilisation, not sterilised while still visibly soiled
- Sterilisation pouches must be correctly sized and sealed, with indicator strips confirming cycle completion
- Autoclave cycles must be logged and validated, not just run and assumed successful
- Sterilised instruments need traceable storage separating clean from used stock
Where practices commonly fall short
The most common gaps are not dramatic failures but small inconsistencies: pouches sized wrong for the instrument inside, logs kept irregularly rather than every cycle, or clean and dirty instrument zones not clearly separated in a small practice's limited space. These are the details CQC inspectors specifically look for because they indicate whether a process is genuinely followed or just exists on paper.
Frequently Asked Questions
What does HTM 01-05 require for sterilisation pouches?
Pouches must be correctly sized for the instrument being sterilised, properly sealed, and include indicator strips that confirm the sterilisation cycle reached the required parameters.
Do autoclave cycles need to be logged for every use under HTM 01-05?
Yes, consistent cycle logging and validation is expected for every sterilisation run, not just periodically, since this traceability is what CQC inspectors typically check.
Is HTM 01-05 a legal requirement or guidance?
It is formally guidance rather than statute, but CQC inspections and infection control assessments treat it as the practical standard dental practices are expected to meet.
Hospitrade supplies self-seal sterilisation pouches in all standard sizes, CQC-compliant and ready for same-week delivery. Shop sterilisation supplies.
For guidance on the pouches themselves, see our sterilisation pouches compliance guide.
