Australian Standards for Bedpan Washers and Steam Sterilizers A Comprehensive Guide

Disclaimer

This content is provided for information only. The authors make no representation or warranty regarding the accuracy, completeness or currency of the content. No information in this whitepaper should be construed as medical advice. Readers should seek appropriate professional guidance before acting on any information contained in this document. The authors expressly disclaim all liability for any direct or indirect loss or damage arising from the use of or reliance on this information.

Introduction

Hospitals, clinics, and aged-care centres rely on two workhorse machines to keep patients safe: the bedpan washer-disinfector which cleans and heat-disinfects human waste containers and the instrument steam sterilizer which sterilizes surgical tools by steam. Australia regulates both device types through national and international standards that set performance targets, test methods, and record-keeping rules. Understanding these rules is essential for anyone involved in buying, maintaining, or replacing the equipment. Compliance with the standards translates complex microbiological requirements into measurable checkpoints, such as cycle temperature, exposure time, soil-removal efficacy, water purity, and automated data capture, all of which protect patients and ensure regulatory compliance. In fact, the Therapeutic Goods Administration (TGA) considers these machines medical devices; any autoclave used in healthcare must be listed on the Australian Register of Therapeutic Goods and meet the applicable standards. Failing to meet these requirements can lead to hefty fines or even shutdowns by regulators. In the long run, strict adherence also lowers total cost of ownership by enforcing regular preventative maintenance and avoiding costly breakdowns.

Why the Standards Matter

A single missed temperature spike or an undetected water-quality fault can leave pathogenic residue on devices that go straight back to patients. The standards provide a clear safety net by turning infection control principles into concrete performance checkpoints. For example, a washer-disinfector’s cycle must achieve a defined thermal disinfection dose measured in time at temperature, and a sterilizer’s cycle must reach a proven combination of steam temperature and pressure for a set duration. Regular tests like soil removal indicators for washers and biological/chemical indicators for sterilizers verify these parameters are consistently met. Compliance not only protects patients from infection, it also shields the facility from regulatory penalties. The TGA can enforce action if a facility is found using non-compliant or unapproved equipment, and Australian accreditation bodies under the National Safety and Quality Health Service standards require that reprocessing of medical devices follows the relevant standards. In short, following AS 5369 and its referenced standards helps ensure patient safety, avoids TGA sanctions, and maintains the facility’s reputation. In the long run, it even saves money: well-maintained machines operating within standard specs suffer fewer breakdowns and last longer than those run to failure.

How the Standards Have Evolved

• Before 2014: Most Australian health services followed manufacturer manuals and earlier editions of the ISO 15883 series for washer-disinfectors and the European EN 285 / EN 13060 codes for large and small steam sterilizers. These provided guidance on performance, but practices varied. There was no unified national mandate, especially outside hospitals.

• 2014 to 2023: The release of AS/NZS 4187:2014 marked a turning point. This standard (“Reprocessing of reusable medical devices in health service organisations”) became compulsory for public hospitals and was strongly recommended for day surgeries and primary care practices. AS/NZS 4187:2014 pulled in ISO 15883-3 by reference, meaning bedpan washer-disinfectors had to meet the performance requirements of that international standard. It also introduced formal installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for every washer-disinfector and every steam sterilizer in use. Each machine had to be tested and documented to prove it performs to standard. In practice, this forced facilities to validate each sterilization cycle type and each washer’s cleaning efficacy upon installation and on a regular schedule. The 2014 standard raised the bar significantly from earlier guidelines.

• December 2023: AS 5369:2023 was published, replacing AS/NZS 4187:2014 and the older AS/NZS 4815:2006 which had applied to office-based practices. For the first time, one unified Australian standard covers reprocessing in all settings, from large hospital CSSDs (Central Sterile Services Departments) to small clinics and even non-health facilities that reprocess devices. AS 5369:2023 merged hospital and office-practice requirements, kept the ISO 15883 references for washer-disinfectors, and aligned its steam sterilization terminology with ISO 17665 (the international moist-heat sterilization standard). Notably, AS 5369 explicitly prohibits dry-heat sterilization cabinets for medical devices, a recognition that modern practice favors steam, and dry-heat ovens are not adequate for critical reprocessing. The new standard also emphasizes risk management and documentation: it includes a risk-based classification of devices (Spaulding categories and “product families”), requires annual staff training in reprocessing, and strengthens requirements for record-keeping and traceability. It even provides a flowchart for classifying devices by steam-penetration resistance. In short, AS 5369 modernized the rules, raising them to international best-practice levels and making them apply universally across Australia. Drying cabinets and other outdated methods have been phased out in favor of validated, traceable processes.

What the Current Rules Demand (AS 5369:2023 in Practice)

Bedpan Washer-Disinfectors: These machines must achieve both cleaning and disinfection of bedpans, urinals, and similar receptacles. The standard (via ISO 15883-1 and 15883-3) specifies a thermal disinfection cycle of at least 80 °C for 1 minute as the minimum to achieve an adequate microbial kill. In practice, most bedpan washers use hot water and steam during the cycle; compliance is verified by thermometric tests measuring cycle temperature over time that must be repeated at least annually to ensure the machine still hits the target. The washer also must prove it can remove a standardized test soil that simulates human waste. ISO 15883-5 describes a test soil containing things like dried blood (often cow or sheep blood) and carbohydrates to mimic the protein and organic load of bodily waste. Facilities use a soil indicator device, essentially a prepared test soil on a coupon or in a surrogate item placed in a load on a regular basis at least weekly to confirm the washer’s cleaning efficacy. If any residue of the test soil remains after the cycle, it indicates the washer is not cleaning properly and needs maintenance. In addition, final rinse water quality is critical: the water used in the last rinse must be demineralised typically via reverse osmosis or deionization and have a conductivity below about 50 µS/cm (micro-siemens per centimeter) to avoid depositing scale or minerals on the utensils. Most facilities log monthly water conductivity readings to ensure they meet this spec and keep records to satisfy auditors. Furthermore, AS 5369 requires an annual microbiological performance test of each washer-disinfector by an independent NATA-certified laboratory. In this yearly audit, a microbiological challenge for example, Enterococcus faecalis or a similar hardy microorganism is run through the washer to verify at least a 6-log10 reduction (a 99.9999% kill) is achieved. Achieving a six-log reduction even for resistant organisms demonstrates the unit’s disinfection stage is effective. Together, these requirements such as thermal measurements, soil tests, water-quality checks, and yearly bio-testing ensure that bedpan washers consistently perform to the level needed to prevent cross-infection from reusable waste containers.

Instrument Steam Sterilizers: Steam sterilizers (autoclaves) come in different sizes, but AS 5369 mandates that all must conform to rigorous design and performance criteria. Large chamber sterilizers, the kind used in central hospital sterile supply departments, are generally expected to meet EN 285 the European Standard for large steam sterilizers for performance. Bench-top or portable sterilizers often found in clinics, dental practices, day surgeries must meet EN 13060 Class B requirements. Class B indicates a vacuum-assisted tabletop autoclave capable of sterilizing wrapped instruments and hollow items. In practice, most modern bench-top units sold in Australia are Class B and have a vacuum pump to remove air. Crucially, all sterilizers must run cycles that have been developed, validated, and routinely controlled in accordance with ISO 17665 the international standard for moist heat sterilization processes. This means you cannot just “guess” a cycle; you must use a cycle time, temperature, pressure profile that has been proven through biological and thermometric validation to achieve sterility for the specific load types in question. Typical default cycles remain 134 °C for 3 minutes for wrapped instruments, general use or 121 °C for 15 minutes for delicate items or prions, but any alternative cycle parameters must be backed by validation data per ISO 17665.

Every day that a steam sterilizer is in use, specific routine tests are required. At the start of each day, an empty-chamber vacuum leak test is performed for vacuum-type sterilizers to ensure the chamber can hold vacuum and there are no air leaks that would impede steam penetration. Also daily, a Bowie-Dick test for sterilizers processing porous loads like textiles or a Helix test for bench-top units processing hollow instruments and lumens must be run. These are process challenge devices designed to confirm effective air removal and steam penetration. A Bowie-Dick is typically a paper indicator pack that changes color only if steam penetrates a dense cotton pack; a Helix is a long narrow tube with an indicator at the end, simulating a lumen instrument. Passing the appropriate daily test gives confidence that the sterilizer will effectively sterilize complex loads. In addition, routine biological indicator (BI) challenges are mandated after any major repair or maintenance and at least every 40 operating hours of use for example, many clinics do a weekly spore test. This involves placing a biological indicator, a capsule or strip containing resistant Geobacillus stearothermophilus spores in a full load and running a cycle, then incubating the BI to ensure all spores were killed. Regular BI tests serve as a periodic check that the sterilizer is truly achieving sterilization conditions inside packs and instruments, beyond just the mechanical gauges.

Water quality for steam generation is another key point: steam sterilizers must use high-purity water typically distilled or reverse-osmosis filtered. AS 5369 and manufacturer specs generally require feed water conductivity below 10 µS/cm for steam generators to prevent mineral buildup. Bench-top units that have internal reservoirs should have their water changed out at least weekly and the reservoir cleaned to prevent biofilm or sediment accumulation. Using poor-quality water can lead to scaling in the heating element, wet loads, and contamination of instruments with residues. To summarize the daily use requirements: document every cycle’s parameters time, temperature, pressure via either print-outs or electronic logs; verify the sterilizer’s gauges or digital readouts against the cycle specifications; and retain all records. AS 5369 places heavy emphasis on automated data capture, ideally, sterilizers should have printers or networked logging so that each cycle’s data and load contents can be traced. Failure to document a cycle is considered non-compliance, since there would be no proof the instruments in that load were sterilized correctly.

Preventative Maintenance

Staying compliant isn’t just about running cycles; it requires meticulous maintenance of the equipment. AS 5369 effectively builds maintenance into the standard e.g. requiring calibration, routine testing, etc. and skipping these tasks not only breaks the standard but voids warranties and invites downtime. Here’s what a solid maintenance schedule looks like, in plain language:

• Every day: The operator should give the machines a quick once-over. For a washer-disinfector, check that spray arms are moving freely and no nozzles are clogged. Many machines will fault if spray pressure is low. For steam sterilizers, wipe the chamber door gasket at the end of the day and again in the morning before use removing any lint or debris helps ensure a tight seal. Inspect the gasket for nicks or cracks daily as well; a damaged door seal is a common cause of failed vacuum tests or steam leaks. Both washers and sterilizers typically have a printout or data log. Confirm that the printer or data logger captured the last cycle and that all parameters were within spec. If something failed or the printout shows an error, address it before continuing. Each day of use, perform the Bowie-Dick or Helix test for sterilizers, as noted above first thing and file the result. Similarly, do the vacuum leak test daily for autoclaves. Daily maintenance is about catching issues early: a quick wipe, visual inspection, and verification of indicators can prevent bigger problems.

• Once a week: Give the washer-disinfector a workout with its soil test. In practice, many facilities run a weekly soil indicator test load using the test soil devices mentioned earlier to verify cleaning performance, this is often done on a Monday morning or Friday afternoon as part of routine QA. Any failure of the soil test should prompt an investigation e.g. are spray nozzles clogged? Is detergent dosing adequate?. For steam sterilizers, weekly tasks usually include draining and refilling bench-top sterilizer water reservoirs. Small autoclaves often don’t automatically flush their reservoirs, so a manual drain helps prevent concentrated build-up of contaminants. In larger plumbed-in sterilizers, water quality is managed by the RO system, but weekly checks of any filters or softeners feeding it are wise. Also, inspect any air filters for vacuum pump vents or air intakes that break the vacuum at cycle end, these should be clean and intact. Clean out sterilizer chamber drains/traps of any lint or residue weekly as well, for example, a chamber drain screen in some autoclaves should be removed and cleaned weekly to prevent clogging.

• Every three months (quarterly): A qualified technician or biomedical engineer should calibrate and verify critical parameters. This typically means checking the accuracy of temperature sensors/probes, pressure gauges, and timing devices. They will run test cycles with external calibrated measurement tools to ensure the displayed temperature and pressure match reality, and adjust if needed. For steam sterilizers, verifying the chamber pressure gauge against a standard gauge is important since sterilization depends on pressure as a proxy for temperature in saturated steam. For washers, verifying the temperature probes in the chamber ensures the 80 °C disinfection temp is correctly sensed. Quarterly service may also include checking and cleaning solenoid valves, lubricating moving parts like door hinges or locks, and verifying detergent dosing pumps in washers are delivering the right amount. This preventative calibration and tune-up keeps the machines within their validated specifications.

• Every six months: Certain parts wear out on about a half-year schedule under heavy use. For example, door gaskets on autoclaves are often replaced every 6 to 12 months as a preventive measure, they harden and crack over time due to heat, even if they haven’t outright failed yet. Proactively replacing them prevents unexpected air leaks. In washer-disinfectors, the spray arm bearings or bushings may be cleaned or replaced semi-annually, and the whole spray arms removed for deep cleaning of internal channels. Any filters, water inlet filters, air filters, etc. are typically changed at this interval as well. This semi-annual refresh prevents gradual performance degradation. A hardened gasket or partially clogged spray nozzle might still allow cycles to “pass” but with reduced efficacy or longer cycle times. Replacing them keeps performance optimal.

• Every year: An independent performance verification is done. This is where the earlier-mentioned NATA-certified laboratory tests come in. Annually, a lab or certified contractor will perform a full validation test on each machine: for a washer, they will run a microbiological test e.g. seeding a test load with Enterococcus faecalis or bacterial spores to confirm the machine still achieves the required log-reduction, and will likely also test cleaning efficacy with soil challenges in hard-to-clean positions. For a steam sterilizer, the annual verification might involve running three consecutive fully loaded cycles with wired thermocouples placed throughout a test load to ensure the required temperature e.g. ≥134 °C for 3 min is reached in all spots. They may also use biological indicators in those loads to double-check sterility is attained. This annual “audit” is essentially a re-qualification of the equipment’s performance. Additionally, yearly maintenance by a technician will include a thorough preventive overhaul: checking heating elements for wear, safety valve testing (for pressure vessels), replacing any worn seals or hoses, updating firmware on controllers if applicable, and so on. All these actions and their results must be documented. Skipping any of these scheduled actions not only violates AS 5369’s requirements for routine monitoring and maintenance but also voids many manufacturers’ warranties and invites unplanned shutdowns. Inadequate maintenance is one of the leading causes of sudden equipment failure, which can be catastrophic when, say, a sterilizer is found not to be sterilizing properly and surgeries must be canceled. Thus, the standards effectively mandate a preventive maintenance culture: invest a little time regularly to avoid disaster later.

Planning for Replacement

Even with excellent maintenance, these machines won’t last forever. Industry data and manufacturer warranties agree on typical service life spans under normal use. For bedpan washer-disinfectors, the expected life is on the order of 10 to 15 years, which corresponds to roughly ~25,000 cycles in a busy environment. For bench-top steam sterilizers, the small Class B autoclaves, it’s a similar 10 to 15 years or about 15,000 to 20,000 cycles of use. These figures assume regular maintenance. Some high-quality models might exceed that range, and indeed some hospital units have been kept running 20+ years, but performance and reliability typically start to decline past the 15-year mark. Large hospital CSSD sterilizers floor-standing bulk autoclaves attached to steam generators are built for heavy-duty use and can sometimes operate up to 20 years with proper upkeep. However, after around 15 years of service, often equivalent to tens of thousands of cycles in a large hospital, their efficiency and reliability drop off. Steam traps, valves, heating coils, control boards. These critical components reach design fatigue or become obsolete, making failures more frequent and repairs harder. In contrast, a sterilizer or washer in a lower-volume setting say a day surgery or a nursing home might not accumulate cycles as quickly and could potentially remain functional longer in calendar years. But even in light-use environments, age and parts obsolescence eventually dictate retirement; rubber seals dry out, electronic controllers from the mid-2000s don’t last forever, and newer standards may outpace the old machine’s capabilities. So, it is wise to treat 10 to 15 years as the planning horizon for replacement in most cases. Pushing beyond that, especially in critical settings, carries a risk of sudden failure or non-compliance with newer requirements.

How do you know when to replace a machine sooner than the typical lifespan? There are a few classic warning signs that signal a machine is nearing the end of its useful life:

• Frequent unplanned breakdowns: If a washer or sterilizer is needing repair more than about 3 times in a year, it’s a red flag. Sporadic minor fixes like a replaced gasket or sensor are normal, but repeated major failures indicate the machine is running on borrowed time. Frequent failures not only disrupt operations but may indicate deeper mechanical wear or control system instability.

• Rising maintenance costs: Another rule of thumb used by engineers is to compare upkeep costs to replacement costs. If the annual service and repair expenses exceed ~10% of the cost of a new machine, the economics favor buying new. For example, spending $5,000 every year to keep an aging sterilizer running when a suitable new unit costs $15,000 to $25,000 is hard to justify beyond the short term. Those funds could be financing a new, more reliable unit. High maintenance costs also often correlate with more downtime, which has hidden costs such as canceled procedures or having to outsource sterilization.

• Parts or support are becoming obsolete: This is a sure sign. If you discover that critical spare parts such as the main PCB, pressure transducer, or door seal are no longer manufactured or stocked by the vendor, or the model has been discontinued without aftermarket support, it’s time to plan for replacement. Many older sterilizers, for instance, use microprocessor boards that eventually become unobtainable a decade or two later. If a key part fails and you can only find second-hand scavenged parts, your machine’s days are numbered. Similarly, if the manufacturer has gone out of business or will no longer service the model, you are running on luck.

In summary, plan for replacement around the typical service life and budget accordingly. In large hospitals (CSSD), this might mean a rolling replacement schedule, e.g. replacing one sterilizer every few years so none exceed ~15 years in service, thereby avoiding simultaneous failures. Hospitals also consider that newer models can offer efficiency benefits such as water/energy saving, faster cycles and improved data connectivity, which older units lack. In day surgeries and clinics, a single bench-top autoclave is mission-critical, so it’s wise to replace on schedule around year 10, before reliability really dips or at least have a backup unit available. These smaller sterilizers often show their age through slower heat-up or occasional failed cycles as they get older. And for nursing homes or ward-based washers, even if use is infrequent, monitor their condition with an eye on age, a lightly used 15-year-old washer can still suddenly fail due to aged heating elements or corrosion. Replacing it proactively avoids an infection control crisis in the aged-care setting, where alternate solutions like disposable bedpan liners might be needed if the washer dies unexpectedly. The key is: do not wait for a catastrophic failure. If you see the warning signs above, start sourcing a new machine while the old one is still limping along. This way you can install and commission the replacement with minimal disruption.

What’s Coming Next

Standards and technology continue to evolve. Looking ahead, there are several developments on the horizon that Australian facilities should watch:

• New editions of ISO 15883 (for washers): In 2024, the ISO released second editions of ISO 15883 Part 1 and Part 3. The core standards that govern general washer-disinfector requirements and the specific requirements for human waste container washers. These updated standards introduce tougher test soils and higher cleaning efficacy thresholds. For example, the formulation of the test soil and the acceptable residual levels after cleaning have become more stringent to better simulate real-world worst-case contaminants. There are also additional performance tests, such as checking for soil removal from not just devices but also the washer chamber walls and loading racks. Australia will likely adopt or reference these new ISO texts in the next few years, expect a draft Australian amendment or adoption by 2026. The practical upshot is that facilities may need washer-disinfectors that are more adjustable and capable. For instance, meeting a tougher cleaning standard might require washers with the ability to dose stronger detergent, use enzymatic cleaners, or allow longer wash phases for heavily soiled items. Older machines with fixed-cycle parameters or weaker spray action might struggle to pass the new tests. Hospitals should keep this in mind when specifying new equipment: ask if the washer is compliant with or upgradable to the latest ISO requirements.

• Upcoming ISO 17665 (sterilization) changes: ISO 17665 (Moist Heat Sterilization) released a fully revised first edition in 2024 consolidating the previous parts. One notable introduction in the 2024 version is allowance for parametric release for certain loads. Parametric release means that if you continuously monitor and control defined critical parameters like time, temperature, pressure, and steam quality within specified tolerances, you can declare the load sterile without a biological indicator result available. This is common in pharmaceutical sterilization and is now creeping into hospital practice for well-characterized loads. It can shorten turnaround times since you don’t need to wait for spore test incubation. If or when Australia’s standards adopt this concept perhaps in a future update of AS 5369 or a guidance document, facilities will likely need sterilizers with more advanced control and monitoring capabilities. For example, deeper vacuum pumps to ensure air removal even from very complex loads for parametric release criteria and extra thermometric ports or electronic sensors to independently verify temperature throughout the chamber might be required. Many older sterilizers cannot be retrofitted with additional sensor ports or may not have the software to perform parametric algorithms. Thus, a push toward parametric release and advanced cycle monitoring could make some older units effectively obsolete. It’s a gentle nudge that new sterilizers should have features like multiple temperature probes, pressure sensors, and perhaps conductivity sensors for steam quality as non-condensable gas measurement is an emerging focus too.

• Energy and data expectations: Sustainability and digital traceability are rising priorities in healthcare technology. There is discussion of an addendum to the Australian Health Facility Guidelines that would cap water and steam consumption per cycle for sterilizers and washers, aiming to drive manufacturers toward more eco-efficient designs. Modern machines already use features like heat exchangers to reclaim energy and water recirculation systems to reduce usage, and these may become expected norms. Similarly, an anticipated amendment to AS 5369 in the next couple of years may require that cycle data be automatically exported to the facility’s network or instrument tracking system within 24 hours of the cycle. In other words, manual record-keeping or leaving printouts in a logbook may no longer suffice, the data should be integrated into electronic records promptly. This ties into the broader push for full traceability of instruments from reprocessing to patient use. Legacy machines that lack network connectivity or USB data export will struggle to meet this requirement; many old bench-top autoclaves, for example, have only a printer or no output at all. Upgrading may not be possible, forcing replacement with newer “smart” models. On the environmental side, legacy machines also often use more water and power than current models e.g. older sterilizers run cooling water continuously, whereas newer ones have thermostatic trap cooling to cut water waste. Regulations capping per-cycle consumption would make it difficult for those older machines to be compliant. We’re already seeing tenders and procurement specs in Australia emphasize energy/water efficiency and digital integration. It’s wise for facilities to anticipate these trends: when budgeting for new equipment, consider units with energy-saving designs, for example, vacuum pumps that don’t require continuous water flow, or standby modes that cut power draw, as well as those that can seamlessly connect to electronic record systems.

In summary, the horizon holds higher performance standards and smarter, greener machines. Washer-disinfectors will need to clean even better and prove it with objective tests, and sterilizers will need to offer more automation in both process control and data handling. Planning capital upgrades with these in mind will save headaches later. Keep an eye out for Standards Australia announcements and guidance from groups like the Australian Commission on Safety and Quality in Health Care regarding implementation of these new international benchmarks.

Glossary

• AS 5369:2023: The current Australian standard for reprocessing reusable medical devices in all healthcare and related facilities. Published in December 2023, it supersedes AS/NZS 4187:2014 and AS/NZS 4815:2006. It aligns Australian practice with international standards and merges hospital and office-based requirements into one.

• AS/NZS 4187:2014: The previous standard (now superseded) that applied primarily to hospital settings. Titled “reprocessing of reusable medical devices in health service organisations” it introduced strict validation and was the standard of reference for hospitals until AS 5369 replaced it.

• AS/NZS 4815:2006: Another superseded standard which provided requirements for office-based health care facilities such as GP clinics, dental offices and day surgeries reprocessing reusable medical and surgical instruments. Its content is now merged into AS 5369.

• TGA (Therapeutic Goods Administration): Australia’s regulatory authority for therapeutic goods, including medical devices. The TGA requires that sterilizers, disinfectors, and related equipment sold for medical use in Australia are included on the ARTG (Australian Register of Therapeutic Goods) and comply with essential principles of safety and performance. The TGA can audit healthcare facilities and manufacturers, enforce recalls, and issue fines if equipment is unsafe or not meeting standards.

• CSSD: Central Sterile Supply Department (also known as Sterile Services Department) , the unit in a hospital responsible for cleaning, disinfecting, and sterilizing equipment. Often contains multiple large sterilizers, washer-disinfectors for surgical instruments, ultrasonic cleaners, etc, and operates with strict workflows (dirty to clean areas).

• Bowie-Dick Test: A daily steam penetration test for vacuum-assisted sterilizers. It consists of a pack of porous material or a chemical indicator pack that the sterilizer must fully penetrate with steam. A uniform color change of the indicator sheet inside confirms effective air removal and steam penetration. It’s primarily for large sterilizers handling porous loads like gowns or drapes.

• Helix Test: A process challenge device used mostly for bench-top (Class B) sterilizers to simulate a long narrow lumen/hollow instrument. It’s a coiled tube with an indicator at the end. If the sterilizer’s vacuum and steam injection can drive steam to the end of the tube, the indicator will change color, confirming adequacy for hollow instruments. Typically done daily in place of a Bowie-Dick in facilities that sterilize handpieces, endoscope parts, etc.

• ISO 15883 Part 3: An international standard specifying requirements and tests for washer-disinfectors intended to clean and disinfect human waste containers, like bedpans and urine bottles. Compliance with ISO 15883-3 is often required for bedpan washers to ensure they achieve effective cleaning and thermal disinfection.

• ISO 17665: The international standard for moist heat sterilization processes (development, validation, and routine control of sterilization by steam). It covers everything from sterilizer equipment requirements to validation methods and is the global benchmark for hospital steam sterilization practices.

• EN 285: European Standard 285: specifies requirements for large steam sterilizers (usually ≥ 60 Liters chamber volume) used in healthcare for sterilizing medical devices. It sets performance criteria like sterilization temperature tolerance, heat distribution, and drying efficacy. Australian standards have long required large hospital sterilizers to meet EN 285 or equivalent, meaning the unit can sterilize full instrument loads reliably at 134 °C, etc.

• EN 13060: European Standard for small steam sterilizers (tabletop autoclaves). Class B cycles per EN 13060 are required for sterilizing wrapped and hollow instruments in bench-top units. If an autoclave is “EN 13060 compliant,” it indicates it has passed specific tests for temperature uniformity, steam penetration using test loads defined by the standard, and other safety features appropriate for small sterilizers.

• Log Reduction: A way to express microbial kill efficacy. “6-log10 reduction” means a 99.9999% kill rate. Each “log” is a factor of 10; so 6 logs = 10^6 reduction in viable count. If a million bacterial spores go in and none come out alive, that’s a 6-log reduction. Standards often require at least 6-log reduction of a hardy test organism to consider a disinfection or sterilization process effective.

• NATA: National Association of Testing Authorities, Australia. This body accredits laboratories to perform various tests and audits. In our context, a NATA-accredited lab might be employed to test a washer-disinfector’s performance, for example, doing microbiological assays to confirm disinfection efficacy or analyzing water samples for purity. Using a NATA lab gives confidence the tests meet international lab standards.

• Parametric Release: A method of releasing processed items from quarantine based on recorded cycle parameters rather than biological indicator tests. For steam sterilization, that means if time, temperature, pressure, and other critical factors were within specified limits throughout the cycle as shown by the sterilizer’s validated monitoring systems, the load is assumed sterile and can be used, without waiting for spore test results. Parametric release requires very high confidence in the sterilization process control, it’s facilitated by modern sterilizers that monitor everything in real time, and it’s now recognized in standards like ISO 17665:2024. It can speed up workflow because items don’t need to sit aside for days pending BI results.

• Reverse Osmosis (RO) Water: Highly purified water produced by forcing tap water through a semi-permeable membrane that filters out ions, minerals, and microbes. RO water usually has very low conductivity (1 to 10 µS/cm range) and is essentially demineralised. In reprocessing, RO water is used for final rinsing of instruments and for feeding steam generators, because its lack of minerals prevents deposits and its lack of microbes prevents recontamination. RO systems are increasingly found in hospitals and even larger clinics to meet the water quality specs of AS 5369.

• Soil Indicator Device: A test object used to verify cleaning performance in washer-disinfectors. It usually consists of a piece of stainless steel or other material coated with a standard test soil, like the dried blood/protein mix defined in ISO 15883-5 or a surrogate item e.g. a plastic bedpan liner with soil applied. The device is placed in a normal load and run through a cycle, then inspected to see if the soil was removed. Some are commercial products with a consistent soil application, often colored for easy visual check. Using these devices periodically e.g. weekly is a way to monitor that the washer’s cleaning function hasn’t deteriorated.

Key Takeaway

If you are responsible for maintaining a bedpan washer or a steam sterilizer in Australia, the current rules give you a clear checklist for success: Hit the target temperatures and exposure times, keep the water ultra-pure, test the cleaning and sterilization efficacy regularly, document every cycle, and invite an independent auditor at least once a year to verify performance. Facilities that diligently follow the daily, weekly, and periodic tasks outlined by the standards will likely enjoy the full service life of their machines with minimal downtime. By calibrating sensors, replacing worn parts proactively, and proving performance with routine indicators, you ensure each cycle is effective and each patient-use item is safe. Conversely, ignoring these practices, whether it’s skipping maintenance, using tap water in a sterilizer, or failing to do weekly tests risks patient safety, violates regulatory requirements, and often leads to early, expensive equipment failure. In an environment where the TGA and accreditation bodies are vigilant, non-compliance can result in not just patient harm but also legal penalties and forced service shutdowns. The bottom line: caring for your reprocessing equipment according to AS 5369 is not just bureaucracy, it is the best insurance against infections and interruptions. By investing time and effort in these standards-based procedures, you protect your patients, your staff, and your budget. Compliance is challenging, but the rewards are safer outcomes and dependable equipment that serves you for years to come.