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| 11 Aug 2025 | |
| Useful Information |
AS 5369:2023 is the new standard for the reprocessing of reusable medical and other devices in both health and non-health-related facilities. It supersedes AS/NZS 4187:2014 and AS/NZS 4815, which have now been formally withdrawn by Standards New Zealand. The shift reflects international best practice and provides clearer, risk-based guidance for safe and effective sterilisation, disinfection, and cleaning of medical devices.
AS/NZS 4187 was introduced nearly 30 years ago, and while foundational, it has since become outdated. AS 5369:2023 introduces:
| Feature | What’s new |
|---|---|
| Product Families | Devices are grouped by steam penetration resistance (SPR), with a ‘master’ product used for testing |
| Spaulding Classification | Clear categorisation of devices (Critical, Semi-critical, non-critical) informs the required level of reprocessing |
| Validation & Monitoring | Emphasises test loads, performance qualification (PQ), and effective sterilisation of grouped devices |
| Risk-Based Focus | Strong alignment to infection risk and end-user safety |
This new national certification scheme will be finalised under the guidance of an Oversight Committee, including:
Certification is delivered by approved Conformity Assessment Bodies (CABs) authorised under the Health and Disability Services (Safety) Act 2001 and approved by the Oversight Committee.
If your facility reprocesses reusable medical devices, we encourage you to:
Updates
