Updating your steri system to AS 5369:2023: a quick guide for dentists
AS 5369:2023 replaced AS/NZS 4815 at the end of 2023. There is no hard deadline, but accreditation assessors now work from it and the ADA guidelines have been rewritten around it. This is a working checklist for a dental practice that wants to bring its sterilisation system up to the new standard without stopping the clinic. It is in patient-safety order, so start at the top.
Step 1. Swap the reference documents (10 minutes)
- Take AS/NZS 4815 and AS/NZS 4187 out of your infection control folder. The ADA guideline's checklist says to do exactly this.
- Replace them with AS 5369:2023 (from Standards Australia) or, at minimum, the ADA Guidelines for Infection Prevention and Control, 5th edition amended, which marks the changes in blue for members.
- Find and replace "4815" in your sterilisation policy, SOPs and log sheets. Why 4815 was replaced explains the background if staff ask.
Step 2. Check your steriliser validation (same day)
- Find the last validation report for each steriliser. It should be to AS 5369:2023 / ISO 17665 and show installation, operational and performance qualification.
- If your own staff did the performance qualification, or the report quotes 4815, book a technician validation at the next due date. Under the new standard the technician does the whole thing: three consecutive loads of each load type, with calibrated data loggers proving the parameters and biological indicators proving the kill.
- Check the report covers your real load types, including hollow items such as handpieces and scaler tips, not just a standard test pack.
- Diary the next-due date and make sure a label with it is on the steriliser.
What changed for validation and servicing has the detail. UDS validates to AS 5369 in Sydney, NSW and the ACT; allow four to five hours per steriliser.
Step 3. Fix the daily test (this week)
- Rename the "Helix test" to the air removal and steam penetration test (ARSPT) on your log sheet and in your SOP.
- Check the device you use states ISO 11140-6 conformance. If not, use up current stock and switch at the next order. You are not expected to throw stock away.
- Pick the right device: follow your steriliser manual; if it does not say, and you process handpieces or other hollow items (you do), use a hollow-device ARSPT every day.
- Run it after warm-up, before the first patient load, every day the steriliser is used, and record the result and lot number.
- Write down what happens on a fail: repeat once, then stop and call. The ARSPT article has the detail.
Step 4. Check the other routine tests
- Vacuum (leak rate) test: at the frequency in your steriliser manual, usually weekly on MELAG and DAC units. Record it.
- Chemical indicators: a Type 1 indicator on or in every pack so the user can see it has been processed. If you run a PCD (hollow device with a Type 2 indicator) in each load of hollow items, keep doing it; Table 8.2 lists it as recommended.
- Cycle records: every cycle logged with date, cycle number, parameters reached and who released the load. On MELAG and DAC units that is the printer, USB or network log. Make sure it is actually kept and backed up.
Step 5. List your product families (one afternoon)
Write down what you reprocess and group it by how hard it is to clean and to sterilise: solid instruments in pouches; hollow instruments (handpieces, scaler handpieces and tips, triplex tips, surgical suction); porous or textile items if any; implant and surgical kits (critical, traced to the patient). Note the cycle each group runs on, and check the instrument makers' instructions for any that really need an extended cycle. Under AS 5369, extended cycles are used only where the instructions ask for them. This list is what your technician validates against.
Step 6. Servicing and water (next service visit)
- Make sure the annual steriliser service is booked with someone authorised for your brand, and that the last service record (what was checked and replaced) is on file with the validation reports.
- Check your feed water meets the maker's specification (demineralised or distilled, low conductivity for MELAG and DAC). Poor feed water is the most common cause of faults on these machines; the error code guides show which codes point to it.
- If you have a reverse-osmosis or deioniser unit, record its cartridge or resin changes.
Step 7. Traceability (review with your practice software)
- Critical items (anything entering sterile tissue: surgical and implant kits, extraction instruments) must be traceable from the patient record to the steriliser cycle by batch control identification.
- Semi-critical items sterilised by steam need not be traced, but if you trace some and not others, be able to explain why.
Step 8. The steri room (plan it, do not panic)
AS 5369 requires dirty and clean work to be properly separated and sets environmental controls such as airflow and temperature. Few existing steri rooms meet every point. The ADA's advice is to write down the gaps and the date you intend to fix them, and to build the changes into any renovation or new build. An assessor expects a plan, not a finished refit. If you are planning a refurbishment, talk to us before the plans are drawn; steriliser, water and drainage requirements are easier to get right on paper.
Step 9. Risk assessment and document control
- Appendix B asks for a written, risk-based review: who was involved, what risks were found at each stage, what controls are in place and when it is reviewed. One meeting and a two-page record is enough for a small practice.
- SOPs and log sheets must be approved by a competent person, dated and version-controlled.
Step 10. Staff competency
Record that everyone who reprocesses instruments has been trained on the updated SOPs, the ARSPT device and the fail procedure, with a date and a signature. The ADA practical guidelines and your steriliser maker's training material cover this. UDS can run a short on-site session when we are in for the annual service.
The one-page version
| Item | Done when |
|---|---|
| 4815 removed, AS 5369 / ADA 5th ed. in folder, policies updated | This week |
| Validation report to AS 5369 with technician-run PQ | Next due date |
| Daily ARSPT, ISO 11140-6 hollow device, logged | This week |
| Weekly vacuum test, per-pack indicators, cycle logs kept | This week |
| Product families listed and matched to cycles | Before next validation |
| Annual service record and water records on file | Next service |
| Traceability for critical items confirmed | This month |
| Room gaps written down with dates | This month |
| Risk assessment and document control in place | This quarter |
| Staff competency recorded | This quarter |
Frequently asked questions
Is there a deadline to comply with AS 5369?
The standard does not set one and the ADA has said immediate compliance is not expected. Accreditation assessors are checking against it now, though, so the steriliser items above should not wait beyond your next validation date.
Do I need to buy a new steriliser?
No. Any Class B benchtop steriliser that can be validated to ISO 17665 and run a daily ARSPT meets the standard. The ADA's advice is to upgrade equipment when it is replaced, not before.
Who can validate our steriliser to AS 5369?
A service provider with calibrated data loggers, biological indicators and the competence to do IQ, OQ and PQ and sign the report. Ask to see a sample report before you book.
Questions about any step, or want validation and servicing done in one visit? Call UDS on (02) 8313 0559.
This checklist is general guidance from a service technician. It is not a substitute for the standard or the ADA guidelines.