Autoclave and steriliser validation is one of the compliance requirements that catches many healthcare facilities off guard. Unlike electrical safety testing, which has a well-understood annual rhythm, AS 5369 validation has multiple components — each with its own frequency — and the documentation requirements are detailed enough that gaps are easy to accumulate without a structured program in place.
This post covers what AS 5369 requires, how often each test type needs to happen, and what your compliance records should look like when a surveyor asks for them.
What Is AS 5369?
AS 5369 is the Australian Standard for reprocessing of reusable medical devices. It covers the full reprocessing cycle — cleaning, disinfection, packaging, and sterilisation — with specific requirements for steam sterilisers (autoclaves) and other sterilisation methods. For most GP practices, day surgeries, and hospitals, the most relevant sections relate to steam sterilisation using bench-top or larger floor-standing autoclaves.
The standard was updated in 2012 (AS/NZS 5369:2023 is now current) and aligns with best practice across Queensland, New South Wales and Western Australian healthcare accreditation frameworks including RACGP Standards, NSQHS Standards, and the Aged Care Quality Standards.
How Often Does Autoclave Validation Need to Happen?
AS 5369 sets out several test types, each with different frequency requirements:
- Daily tests — Bowie-Dick (or equivalent air removal) test each day the autoclave is used, plus a manual check of the cycle parameters (time, temperature, pressure). These are typically done in-house by trained staff.
- Weekly tests — biological indicator or chemical indicator tests depending on the steriliser type and your facility’s protocol.
- Quarterly validation — a full performance qualification (PQ) by a qualified service provider, including calibration of temperature and pressure sensors, air removal testing, and load testing with biological indicators. This is the test that requires an external biomedical or sterilisation engineer.
- Annual validation — a comprehensive operational qualification (OQ) and PQ, typically including a physical inspection of the chamber, door seals, and safety systems in addition to all the quarterly tests.
Some facilities operate on a six-monthly external validation cycle rather than quarterly — check your accreditation framework’s specific requirements, as RACGP and NSQHS have slightly different expectations.
What Do Surveyors Look For?
When RACGP, AGPAL, QIP, or NSQHS surveyors assess your sterilisation compliance, they typically ask to see:
- Daily Bowie-Dick and cycle log records going back at least 12 months
- Quarterly or six-monthly external validation reports from a qualified service provider
- Evidence that failed tests were investigated and documented
- Staff competency records showing who is authorised to operate the autoclave
- The autoclave’s service and calibration history
- Your sterilisation policy and procedure document referencing AS 5369
A common gap is having external validation reports but no complete daily log — or vice versa. Both are required.
Bench-Top vs Floor-Standing Autoclaves
The validation requirements differ slightly depending on the class of autoclave:
- Class B (vacuum) autoclaves — used in most GP practices and day surgeries for wrapped and hollow instruments. Require Bowie-Dick testing and the full quarterly/annual validation program.
- Class S autoclaves — designed for specific load types defined by the manufacturer. Validation requirements follow the manufacturer’s specification as well as AS 5369.
- Class N autoclaves — unwrapped solid instruments only. Less demanding validation requirements but still require periodic external testing and daily cycle monitoring.
Who Can Perform External Autoclave Validation?
External autoclave and steriliser validation under AS 5369 needs to be carried out by a qualified biomedical engineer or sterilisation technician with the appropriate equipment and training. The validation report needs to include calibrated instrument readings, not just a pass/fail statement.
Nova Biomedical provides AS 5369 autoclave and steriliser validation for GP practices, hospitals, day surgeries, and aged care facilities across Queensland, New South Wales and Western Australia. Our reports are structured to meet the documentation requirements of RACGP, AGPAL, QIP, and NSQHS accreditation.
FAQ
How often does an autoclave need external validation under AS 5369?
Most facilities require external validation quarterly or six-monthly, depending on their accreditation framework. Annual comprehensive validation (operational and performance qualification) is required regardless of the quarterly schedule.
Can daily Bowie-Dick tests be done in-house?
Yes — daily Bowie-Dick and cycle monitoring tests are designed to be done by trained staff in-house. External validation is required for the more detailed quarterly and annual performance qualification testing.
What happens if we fail a Bowie-Dick test?
A failed Bowie-Dick test means the autoclave should not be used for that cycle. The failure should be documented, the cause investigated (often a faulty test pack, air leak, or steam quality issue), and the autoclave retested before returning to service. All of this needs to be recorded.
Does AS 5369 apply to dental practices?
Yes — dental practices using autoclaves for instrument reprocessing are subject to AS 5369 requirements, and dental accreditation bodies expect compliance documentation aligned with the standard.
How do I know which class of autoclave I have?
The class (B, S, or N) should be on the autoclave’s data plate or in the manufacturer’s documentation. Your biomedical service provider can confirm this during a validation visit.
Related Services
Nova Biomedical provides autoclave and steriliser validation to AS 5369 for GP practices, hospitals, day surgeries, and aged care facilities. We also provide RACGP, AGPAL and QIP equipment compliance support and PPM contracts to keep your testing program on schedule. Contact us for a quote.
