Dental practice sterilisation in Belgium: what the Superior Health Council asks

Sterilisation is not something you set up once and forget. Every cycle, every morning test and every sealed pouch has to be right, and you need to be able to prove it afterwards. If you run the sterilisation room of a Belgian dental practice, two questions come up fast: which recommendations actually apply, and what should you record? This article walks through the full cycle from cleaning to storage, what to log per day, week and year, and which consumables each step uses. Everything is based on the advisory reports of Belgium's Superior Health Council (SHC), with links to the source.

Which guidelines apply in Belgium?

Two SHC reports have to be read together:

• SHC 8363 (2011): recommendations on infection control in dental care, published in Dutch and French. It is still the dental reference: instrument categories, cleaning, the type of autoclave and how to process handpieces.
• SHC 9682 (2023): Sterilisation of reusable medical devices. It replaces the earlier sterilisation recommendations and states that references to them in other reports, including SHC 8363, should now be read as references to this one. It covers care both in and outside hospitals, including private practices.

Two caveats. SHC reports are recommendations, not law. And 9682 is written largely for hospital central sterile services. Below, we only take what also applies to a practice with a small steam steriliser.

Step 1: pre-treatment, cleaning and disinfection

SHC 8363 sorts instruments by risk. Critical instruments (surgery, endodontics) are cleaned, dried and sterilised. For semi-critical instruments that touch mucosa, such as mirrors, probes or filling instruments, thermal disinfection is enough. Non-critical items are cleaned and dried. Single-use items are never reprocessed.

• Keep them moist, don't soak them. Stop debris from drying before processing, but don't leave instruments in a bath for long (corrosion).
• Clean by machine. A washer-disinfector is strongly preferred. A household dishwasher is not suitable. Per SHC 9682, an A0 value of at least 600 is required when sterilisation follows.
• Ultrasonic for small items. For burs, endo files and other fragile dental instruments, the SHC recommends an ultrasonic bath with a suitable solution that you replace on time. Test it at least once a week with a PCD.
• Manual cleaning only as an exception. Do it under water, with a long-handled brush and protective equipment.

Handpieces are cleaned inside and out, lubricated with heat-resistant oil, then wrapped and autoclaved.

Step 2: packaging and labelling

Anything that must stay sterile is sterilised wrapped. According to SHC 9682:

• Use pouches that meet ISO 11607 / EN 868, preferably peel-open laminate pouches with a lot number.
• Contents take up no more than 75% of the porous surface. No folding.
• Seal with a validated heat sealer that you test daily, and check the seal before and after sterilisation.
• Each pack gets a class 1 process indicator and an expiry date. Never write on the pack itself; use a label.
• The label carries at least an identification code. Production date, lot and expiry date make tracing much easier.

Step 3: the sterilisation cycle and release

For dentistry, SHC 8363 recommends a small steam steriliser to EN 13060. Class B is indispensable as soon as you sterilise critical instruments or hollow items such as handpieces. Load the chamber no more than ¾ full and stand pouches upright. Hot-air and glass-bead sterilisers do not guarantee sterility.

A load can only be released when time, pressure and temperature match the validation, the indicators have changed colour, the load is dry and every pack is intact. If any one check fails, the load counts as non-sterile and is repacked and resterilised (SHC 9682). An indicator only shows that a pack went through a cycle, not that it is sterile.

Which tests, and how often?

Check	Frequency	Source
Time, pressure, temperature, indicator, dryness and packaging	Every cycle	SHC 8363, 9682
Bowie & Dick test (test pack) in the empty, pre-heated steriliser	Daily before the first load and after any technical intervention	SHC 9682
Heat sealer test	Daily	SHC 9682
Ultrasonic bath performance (PCD)	At least weekly	SHC 9682
Vacuum leak test (max. 1.3 mbar/min)	Weekly	SHC 9682
Autoclave cleaning per the manufacturer	Weekly	SHC 8363
Safety and leak-tightness check by an external technical inspection body	At purchase, then yearly	SHC 9682
Steriliser requalification, heat sealer calibration and validation	Yearly	SHC 9682

What about biological indicators? SHC 8363 still recommended them in 2011. SHC 9682 now considers them no longer appropriate, except for 121 °C cycles. After a failed Bowie & Dick test, production only restarts once a test passes.

Storage and shelf life

Store sterile items somewhere dry, clean and out of direct sunlight. SHC 9682 mentions 15 to 25 °C and relative humidity around 60%. Shelf life is no longer a fixed number. SHC 8363 still said it was "best not to exceed 6 months", but under 9682 you set it through a risk analysis based on packaging, storage conditions and handling. Always check the pack just before use. A damaged or damp pouch is no longer sterile.

What should you record?

• Per cycle: date, steriliser, cycle number and programme, the parameters or printout, the result of the indicator, dryness and packaging checks, who released the load, and which sets were in it.
• Per patient: which set was used. SHC 9682 calls for an identification code per set that can be linked to the patient and the cycle.
• Per day and week: the Bowie & Dick, heat sealer, ultrasonic and vacuum leak tests, and autoclave cleaning.
• Per year: reports from external inspection, requalification and calibration, plus maintenance and repairs.

Consumables, step by step

• Cleaning: detergent for the washer-disinfector, cleaning and disinfecting solution for the ultrasonic bath, PCD tests for the ultrasonic bath, brushes, gloves and eye protection. Under SHC 8363, a disinfectant must be a CE-marked medical device or an authorised biocide.
• Packaging: laminate pouches or reels in several sizes, process indicators or indicator tape, labels.
• Sterilisation: Bowie & Dick test packs, reverse-osmosis or demineralised water as the manufacturer specifies (the SHC recommends osmosis water), handpiece oil.

Run out of any one of these and the whole chain stops. No test pack means no release; no pouches means no wrapped sterilisation.

What about the Netherlands?

Dutch practices follow the KNMT guideline Infectiepreventie in mondzorgpraktijken (2016). It requires a steam steriliser to EN 13060, documenting your own cycles and user maintenance, periodic maintenance under NEN R8153, and resterilisation no later than six months after sterilisation. The guideline is being revised: comments are open until 14 November, and the final version will follow.

Tracking sterilisation consumables with Swyp

In Swyp, you set a minimum stock for pouches, test packs and solutions. When an item drops below it, it is added to your order list automatically. You order from all your suppliers in one cart, and Scout compares prices and suggests a better offer. You approve every change. That way, there is always a test pack ready for tomorrow morning.

Read next

To set that threshold per item, read how to calculate minimum stock in a dental practice. To manage all your stock digitally, see our guide to dental practice inventory management. Opening a new practice? Use the dental supplies checklist. Ready to get your sterilisation consumables under control? Try Swyp free.

Sources

• Superior Health Council, SHC 8363 – Infection control in dental care (May 2011, Dutch; French version)
• Superior Health Council, SHC 9682 – Sterilisation of reusable medical devices (2023)
• KNMT, Infectiepreventie in mondzorgpraktijken (2016, under revision, Dutch)
• KNMT, Call for comments on the revised guideline (Dutch)