AS 5369:2023: what changed for autoclave validation and servicing
AS 5369:2023 replaced AS/NZS 4815 as the reprocessing standard for dental practices. Most of the talk has been about room layout and paperwork. This article covers the part we deal with every day: what changed for the steriliser itself, its annual validation and its servicing.
1. Validation is now the technician's job, start to finish
This is the biggest practical change. Under 4815 it was common for a service company to do a quick thermometric check and leave the practice to run the biological indicator cycles itself, or to hand over a template for the practice to fill in. Neither half on its own is a validation.
AS 5369 and the ADA guidelines are clear: the technician does the whole performance qualification. That means three consecutive loads of each load type, with calibrated data loggers recording temperature and pressure inside the packs to prove the cycle parameters, and biological indicators to prove the kill. Practice staff only do it in rare cases, such as a remote practice with no technician available.
On the day, the technician runs each load type through three full cycles with loggers in the packs and biological indicators at the hardest-to-reach points, incubates the indicators and signs the report. At UDS we use rapid-read indicators so you have the result before we leave. Allow four to five hours per steriliser. Our servicing and validation page explains the full procedure.
2. Validation follows IQ, OQ and PQ
AS 5369 points to ISO 17665 for steam sterilisation. A validation report should show three parts:
- Installation qualification (IQ): the steriliser is the model and serial on record, installed to the maker's requirements, with the right water, drainage and power.
- Operational qualification (OQ): the empty chamber reaches and holds sterilising conditions, and the steriliser's own readings agree with independent calibrated loggers.
- Performance qualification (PQ): your real loads, in your real packaging, reach sterilising conditions in every pack, proven by loggers and biological indicators.
Validation is needed at installation, after a move, after any repair that could affect performance, and at least once a year. If a report you have been given does not show all three parts, ask why.
3. Loads are grouped into product families
Instead of testing "wrapped" and "unwrapped", the standard asks you to group instruments by how hard they are to clean and sterilise, and to validate each group with its worst-case load. For a dental practice that usually means: solid instruments in pouches; hollow items (handpieces, scaler tips, triplex tips, suction); porous or textile items if you have any; and your heaviest routine load. The technician should ask what you actually sterilise and build the validation around it, not run a standard test pack.
4. Biological indicators: new reference standard
Biological indicators now follow ISO 11138-7. The old reference, ISO 14161, has been withdrawn. In practice: use indicators with a stated population and resistance for the 134 °C steam cycle, incubate them the maker's way, and run a positive control with every set. Ask your technician which indicator they use and how it is read.
5. No more "extended cycle to be safe"
Clause 6.5.1 says an extended cycle is used where the instrument maker's instructions ask for one. If an instrument is sterile after a standard cycle, it should not be run on an extended cycle unless the instructions allow it. Longer is not safer. It wears handpiece bearings and seals and can damage some materials. If your practice defaults to an extended cycle, check the instructions for the instruments concerned.
6. The daily test was renamed and tightened
Amendment 1 renamed the Bowie-Dick-type test the air removal and steam penetration test (ARSPT). "Helix test" is now listed as a historical term. For a benchtop steriliser the test device must meet ISO 11140-6, and if hollow instruments go through your steriliser the standard expects a hollow-device test every day. Our ARSPT article covers it in detail.
7. A PCD in every load is recommended, not required
Table 8.2 lists a process challenge device in each load as recommended but optional for sterilisers without an air detector, which is nearly every benchtop unit. If you already run a hollow PCD with a Type 2 indicator in every load of hollow items, keep doing it. It is your only per-load proof of steam penetration.
8. Servicing: what the standard expects of the machine
AS 5369 does not write a service schedule for your steriliser. It requires the steriliser to be maintained to the maker's instructions and the maintenance to be recorded. For the units we see most, that means:
- MELAG Vacuklav 23 B+ / 43 B+ and Dentsply Sirona DAC Professional / Premium: annual maintenance by an authorised technician, or at the cycle count in the manual if that comes first. It covers the door seal, filters, valves, pressure-release path, feed water system, a safety check and a check of the temperature and pressure sensors against calibrated instruments.
- A record of every service, with what was replaced, kept with the validation records.
A service keeps the machine running; validation proves the result. You need both. And because a repair that affects performance means a revalidation, it is cheaper to book them together. If your steriliser is showing a fault, our MELAG and DAC error code guides explain what the number means.
9. Water quality
The water requirements did not change; they carried over from AS/NZS 4187 and now apply to you. Benchtop sterilisers must be fed with water that meets the maker's specification. For MELAG and DAC units that is demineralised or distilled water with low conductivity. Poor feed water is the most common cause of the faults we are called to on these machines. Keep a record of the water you use and, if you have a reverse-osmosis or deioniser unit, of its cartridge changes.
10. Records and traceability
Keep validation reports, service records, daily ARSPT results, cycle logs and biological indicator results together for each steriliser. Critical instruments (anything that enters sterile tissue) must be traceable to the patient through 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. Retention follows your state's health records rules; most practices keep steriliser records for at least seven years.
What to check before your next validation
- Is the report to AS 5369:2023 and ISO 17665, showing IQ, OQ and PQ?
- Did the technician run the three consecutive cycles per load type with data loggers and biological indicators, or were you asked to do any of it?
- Were your real load types tested, including hollow items?
- Is your daily test device an ISO 11140-6 ARSPT that suits your loads?
- Is the annual service recorded, and done by someone authorised for your brand?
UDS services and validates sterilisers to AS 5369 across Sydney, NSW and the ACT. We are an authorised Dentsply Sirona service partner and MELAG dealer. Call (02) 8313 0559 to book validation with your annual service.
Frequently asked questions
How often does a dental autoclave need validation under AS 5369?
At installation, after a move or a repair that could affect performance, and at least once every 12 months.
Can our practice manager still do the biological indicator cycles?
Not as part of validation. The performance qualification, data loggers and biological indicators together over three consecutive loads, is the technician's job under AS 5369 and the ADA guidelines, except in rare cases such as a remote practice with no technician available.
Is servicing the same as validation?
No. Servicing maintains the machine. Validation measures the result inside the chamber with independent instruments and biological indicators. You need both every year, and they are usually done in one visit.
How long do we keep steriliser records?
AS 5369 requires records to be kept and traceable; the retention period follows your state's health records rules. Seven years is the usual minimum in NSW and the ACT. Check your indemnity insurer's advice as well.
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.