AS 5369:2023 vs AS/NZS 4187 — What Changed for Dental Practices?
Published: April 2026
Category: Dental Compliance
Reading time: 6 minutes
In December 2023, Standards Australia released AS 5369:2023, replacing both AS/NZS 4187:2014 and AS/NZS 4815:2006. If your practice was compliant under the old standard, you're not automatically compliant under the new one — and water quality testing is one of the areas where the requirements changed most significantly.
This guide covers what actually changed, what it means for your practice, and what you need to do if you haven't updated your compliance programme yet.
Why Was AS/NZS 4187 Replaced?
AS/NZS 4187:2014 was primarily written for large hospital central sterile supply departments. It was complex, technically demanding, and difficult to apply to small office-based healthcare settings like dental practices. AS/NZS 4815:2006, which covered office-based facilities, was a separate document with its own requirements.
AS 5369:2023 consolidates both into a single standard covering all facilities that reprocess reusable medical devices — from major hospitals down to single-chair dental practices and allied health clinics. The objective was a unified, risk-based framework applicable across all settings.
What Stayed the Same
The fundamental requirement hasn't changed — if your practice sterilises reusable instruments on-site, you must use purified water that meets defined quality limits in your sterilisation room, and you must test it.
The core water quality parameters — conductivity, hardness, chloride — remain largely consistent with the previous standard. Monthly routine monitoring of these chemistry parameters was required under AS/NZS 4187 and remains required under AS 5369:2023.
What Changed — Water Quality Testing
This is where AS 5369:2023 introduced the most significant updates for dental practices.
Bacterial Endotoxins — New Requirement
The most discussed change is the addition of bacterial endotoxin testing to Table 7.2 — the annual washer-disinfector final rinse water audit.
Under AS/NZS 4187, endotoxin testing was not required for office-based dental facilities. Under AS 5369:2023 it is. Your annual washer-disinfector audit must now include a Bacterial Endotoxins test by LAL (Limulus Amebocyte Lysate) kinetic-chromogenic method, with a limit of ≤0.25 EU/mL.
Endotoxins are heat-stable toxins released by Gram-negative bacteria. They can survive standard sterilisation processes and transfer to patients through instruments. The addition of this test reflects an updated understanding of infection risk in instrument reprocessing.
If your current laboratory testing programme does not include endotoxin testing, it does not fully meet AS 5369:2023 requirements — regardless of whether all other parameters are within limits.
Total Viable Count Method — Clarified
AS 5369:2023 specifies that Total Viable Count (TVC) testing must use membrane filtration in accordance with ISO 15883-1. Pour plate or dip-slide methods are not acceptable for compliance purposes.
This matters because some practices were using in-house dip-slide tests or non-accredited strip tests to satisfy the TVC requirement under the old standard. These do not satisfy AS 5369:2023. TVC must be conducted by a NATA-accredited laboratory using the membrane filtration method.
Table Structure — Reorganised
AS/NZS 4187 used different table references. AS 5369:2023 reorganises the water quality requirements into:
Table 7.2 — Final rinse water for manual cleaning and washer-disinfectors (annual audit)
Table 7.4 — Feedwater to dedicated steam generator autoclaves (annual audit)
Table 8.1 — Routine monitoring parameters and frequency (monthly)
If you or your compliance adviser refer to old table numbers from AS/NZS 4187, these no longer apply.
Combined Testing Now Recognised
AS 5369:2023 explicitly recognises that where a washer-disinfector and autoclave share the same purified water supply — the most common configuration in dental practices with a single RO unit — a single sample can satisfy both Table 7.2 and Table 7.4 requirements. This wasn't clearly articulated in the previous standard and is a practical improvement for smaller practices.
What Changed — Broader Scope
Non-Healthcare Facilities Now Included
AS/NZS 4815:2006 covered office-based healthcare facilities. AS 5369:2023 extends to non-healthcare facilities that use reusable instruments — beauty salons, tattoo parlours, and similar settings. This doesn't directly affect dental practices but it's worth understanding that the standard now applies beyond the healthcare sector.
Risk-Based Classification System
AS 5369:2023 introduces a formal risk-based classification of reusable medical devices using the Spaulding classification system (critical, semi-critical, non-critical). This provides clearer guidance on which instruments require which level of reprocessing. For most dental practices the practical impact is limited but it provides a more defensible framework for your sterilisation procedures.
The Transition Timeline
AS 5369:2023 was released on 15 December 2023 but did not include a mandatory compliance deadline in the standard itself.
However, Advisory PCHS24/01 required healthcare services using critical and semi-critical reusable medical devices to complete a gap analysis against AS 5369:2023 by 30 June 2025. If your practice hasn't done this, it's overdue.
For dental practices approaching their second accreditation cycle, QIP and AGPAL assessors are now assessing against AS 5369:2023, not AS/NZS 4187. A practice that cannot demonstrate water testing under the new standard is at risk of a non-compliance finding.
What You Need to Do
If your practice was testing under AS/NZS 4187 and hasn't reviewed your programme since the new standard was released, the key questions to ask are:
1. Does your annual audit include bacterial endotoxin testing? If not, your current annual audit does not satisfy AS 5369:2023 Table 7.2. This is the most common gap.
2. Is your TVC being tested by membrane filtration at a NATA-accredited laboratory? If you're using in-house dip-slides or non-accredited strip tests for TVC, these need to be replaced with NATA-accredited membrane filtration testing.
3. Are you testing against the correct table references? Make sure your reports reference AS 5369:2023 Tables 7.2, 7.4 and 8.1 — not the old AS/NZS 4187 table numbers.
4. Have you completed a gap analysis? If not, this is the starting point. Review your current sterilisation room procedures, water system and testing programme against AS 5369:2023 and document the gaps and actions taken.
How Clear Compliance Labs Can Help
Our dental testing range is built specifically around AS 5369:2023 — not the old standard. Every kit includes the correct parameters including bacterial endotoxin testing where required, conducted by a NATA-accredited laboratory using the specified methods.
If you're not sure whether your current testing programme meets the new standard, contact us and we'll point you in the right direction.
Our dental testing range:
Monthly Sterilisation Room Test — Table 8.1 routine monitoring, from $442/month
Washer-Disinfector Annual Audit — Table 7.2 including endotoxins, $949
Autoclave Feedwater Test — Table 7.4, $795
Combined Annual Audit — Tables 7.2 + 7.4, $1,249 (saves $495)
View our full dental testing range →
Clear Compliance Labs is a trading name of Drink Safe Australia Pty Ltd (ACN: 688 581 722). This article is intended as general guidance only and does not constitute professional compliance or legal advice. For specific advice on your practice's compliance obligations, consult your accreditation body or a qualified infection control adviser.