AS/NZS 4815 is gone: why it was replaced and what AS 5369:2023 means for your practice
If your sterilisation manual, your validation report or the label on your steriliser still says AS/NZS 4815, it is out of date. AS/NZS 4815 was withdrawn when AS 5369:2023 was published on 15 December 2023. Here is what 4815 was, why it was retired, and what your practice needs to do about it.
What AS/NZS 4815 was
AS/NZS 4815:2006 was the reprocessing standard for small practices: dentists, GPs, podiatrists, skin clinics. It was the document the ADA infection control guidelines pointed to for steriliser testing, packaging, storage and records.
Hospitals and day surgeries worked to a different standard, AS/NZS 4187, which asked for more: fuller validation, water testing and traceability. So a dental practice could run to lighter rules than a hospital sterilising the same instrument.
Why it was replaced
- It was old. 4815 was written in 2006. The international standards it relied on have been rewritten since: ISO 17665 for validating steam sterilisation, ISO 11140-6 (2022) for the daily air removal test, and ISO 11138-7 for biological indicators. 4815 could not point to documents that did not exist yet.
- Two standards, one risk. A handpiece used for an extraction carries the same risk whether it was reprocessed in a hospital or a two-chair practice. Standards Australia decided one risk-based standard should cover every place that reprocesses reusable instruments, from a tertiary hospital to a single-chair surgery, and even tattoo and beauty studios.
- The equipment changed. In 2006 most benchtop sterilisers were simple N-type units. Today the normal dental steriliser is a Class B unit (MELAG Vacuklav, Dentsply Sirona DAC Professional and Premium, W&H Lisa, Mocom) that logs every cycle. The new standard assumes that equipment and asks for the records it can produce.
What replaced it
AS 5369:2023, Reprocessing of reusable medical devices and other devices in health and non-health related facilities. One document now replaces both AS/NZS 4815 and AS/NZS 4187. Amendment 1 followed and, among other things, renamed the daily steriliser test the air removal and steam penetration test (ARSPT).
The ADA rewrote its Guidelines for Infection Prevention and Control (5th edition, amended) around AS 5369. The guideline's checklist now tells practices to remove any copies of AS/NZS 4815 and AS/NZS 4187 from use. The Dental Board requires you to follow current infection control guidelines, and that is what makes AS 5369 binding on a dental practice, even though a standard is not itself a law.
Is there a deadline?
No. The standard does not set one, and the ADA has said nobody expects immediate compliance. The pressure comes from accreditation: QIP and AGPAL assessors are now checking against AS 5369, and a validation report or daily test regime that still quotes 4815 will be noticed.
The ADA's advice is practical. Do a gap analysis. Rank the gaps by risk. Fix the patient-safety ones now (steriliser validation, daily testing, documents) and plan the building ones (room layout, airflow) for your next refurbishment. Our quick guide to updating your steri system works through that list.
What actually changes for a dental practice
| Area | Under AS/NZS 4815 | Under AS 5369:2023 |
|---|---|---|
| Who validates the steriliser | Often done, or partly done, by practice staff using the service company's template | The technician does the whole performance qualification: three consecutive loads of each load type, with calibrated data loggers checking temperature and pressure inside the packs and biological indicators checking the kill. Staff only do it in rare cases, such as remote practices |
| Daily steriliser test | "Helix" or "Bowie-Dick" test, device chosen loosely | Air removal and steam penetration test (ARSPT) to ISO 11140-6; a hollow-device test every day if handpieces, scaler tips or triplex tips go through the steriliser |
| Load types | Informal | Instruments grouped into product families; each family validated |
| Extended cycles | Often used "to be safe" | Only where the instrument maker's instructions ask for one |
| Biological indicators | ISO 14161 (now withdrawn) | ISO 11138-7 |
| Traceability | Batch control for surgical items | Critical items traced to the patient; steam-sterilised semi-critical items need not be, but the system should be consistent |
| Steri room | Guidance on workflow | Dirty and clean work must be properly separated; airflow and temperature controls specified |
| Risk management | Implied | A written, risk-based review (Appendix B) that is kept up to date |
For the steriliser detail, read what changed in AS 5369 for autoclave validation and servicing.
What to do this month
- Take AS/NZS 4815 out of your infection control folder. Change the reference in your policies to AS 5369:2023 and the ADA Guidelines 5th edition (amended).
- Check the last validation report for each steriliser. If it quotes 4815, or your staff did part of it, book a validation to AS 5369 at the next due date. UDS validates to AS 5369 across Sydney, NSW and the ACT.
- Check which daily test device you use and whether it suits your steriliser and your instruments.
- Write down the gaps you cannot fix yet, with a date, so an assessor can see the plan.
Frequently asked questions
Can I still use my AS/NZS 4815 validation certificate?
Keep it; it records what was done at the time. But it will not satisfy an assessor as proof of current compliance. Your next validation should be done and reported to AS 5369:2023.
Does AS 5369 apply to a single-chair practice?
Yes. It covers every facility that reprocesses reusable instruments, and it names dental and office-based practice specifically. The requirements scale with what you reprocess, not the size of the building.
Where do I get a copy?
From the Standards Australia store (it is a paid document). The ADA guideline's member edition summarises the parts that matter to dentists and marks the changes in blue.
Who wrote the new standard?
Standards Australia's reprocessing committee, with input from infection control bodies, state health departments, sterilising services and professional associations including the ADA.
This article is general guidance from a service technician. It is not a substitute for the standard or the ADA guidelines; check your own copy for the exact wording.