Top 10 Key Differences Between AS/NZS 4815 and AS 5369

Written by Michael Stanton | 03-Jun-2025 22:44:40

Introduction

If your clinic or healthcare facility is still using AS/NZS 4815:2006, you're working under an outdated framework. The newly introduced AS 5369:2023 is a modernised, risk-based standard designed to enhance infection control and sterilisation practices in Australia. Below, we compare the top 10 differences between AS/NZS 4815 and AS 5369, with a focus on documentation compliance, staff training, and reprocessing protocols.

Read on to discover the Top 10 differences between the standards.

1. Scope of AS 5369 for Healthcare and Personal Services

AS/NZS 4815 was limited to office-based healthcare settings.
AS 5369 applies broadly to all healthcare and personal service environments—including dental clinics, beauty salons, body art studios, and day surgeries.

2. Australia-Only Sterilisation Standard

AS/NZS 4815 was a joint Australia–New Zealand standard.
AS 5369 is Australia-specific, aligning with local health regulations and audit requirements.

3. Risk-Based Instrument Classification in AS 5369

AS 5369 introduces a risk-based sterilisation classification system—categorising instruments as critical, semi-critical, or non-critical.

AS/NZS 4815 used a more generalised, prescriptive approach.

4. Modernised Terminology for Sterilisation Compliance

AS 5369 updates terminology in line with ISO standards. Terms such as “Sterile Supply Department” become “Central Sterile Supply Department (CSSD)”.
This replaces outdated language in AS/NZS 4815.

5. AS 5369 Documentation Requirements for Sterilisation Processes

AS 5369 mandates detailed records of each sterilisation cycle, including:

Load identification
Operator initials
Sterilisation cycle data

AS/NZS 4815 required only basic recordkeeping.

6. Mandatory Staff Training and Competency Checks in AS 5369

Unlike AS/NZS 4815, AS 5369 requires:

Documented staff competency assessments
Ongoing infection control education
Refresher training in sterilisation procedures

7. AS 5369 Reprocessing Guidelines for Reusable Medical Devices (RMDs)

AS 5369 includes detailed reprocessing instructions aligned with manufacturer’s IFUs.
AS/NZS 4815 offered only general guidelines.

8. Infection Control Facility Layout Requirements under AS 5369

New layout standards include:

Air quality control
Zoning between clean and dirty areas
Directional workflow

9. Steriliser Validation Protocols Required by AS 5369

AS 5369 introduces:

Operational Qualification (OQ)
Performance Qualification (PQ)
Routine tests (Bowie-Dick, leak, chemical/biological indicators)

AS/NZS 4815 only required basic functionality checks.

10. Alignment Between AS 5369 and AS/NZS 4187

AS 5369 is more closely aligned with AS/NZS 4187 than AS/NZS 4815, ensuring consistency between hospital sterilisation practices and primary care facilities.

Final Thoughts: Transitioning to AS 5369 for Best-Practice Compliance

Adopting AS 5369 means more than meeting regulatory obligations—it’s a step toward safer patient outcomes and operational excellence. From risk-based sterilisation processes to mandatory staff training, this standard sets a high bar.

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