Standards

Working to Current Standards

Standards define the materials, methods, processes, practices, and outcomes required for quality and safety. They establish strict benchmarks, outline best practices, and provide reliable guidance.

We rigorously follow and test against the latest national and international standards to ensure your equipment remains accurate, reliable, and safe for clinical use.

AS/NZS 3551:2012

Technical management programs for medical devices

This standard is essential for best-practice repair, testing, and management of medical equipment. AS/NZS 3551 requires that all persons or organisations using medical devices conduct regular safety and performance verification.

What we do: We perform mandatory biomedical electrical safety testing (including patient leakage current measurements) and precise calibration. This process manages clinical risk, ensures compliance with national electrical safety regulations, and provides peace of mind.

AS/NZS 5369:2023

Reprocessing of reusable medical devices in health and non-health related facilities

Compliance is simplified for your facility. Under the unified AS 5369:2023 standard (which replaces AS/NZS 4815 and AS/NZS 4187), stringent requirements for regular steriliser validation, data logging, and washer-disinfector testing are now mandatory. We support your business with comprehensive, manufacturer-aligned servicing and calibration.

Performance Qualification (PQ): Full multi-cycle biological and chemical testing using calibrated data loggers to prove your steriliser achieves effective disinfection and sterilisation, as well as eliminating bioburden.
Preventative Maintenance: Routine servicing of seals, chambers, valves, and sensors to prevent unexpected equipment failure and downtime.
Compliance Certification: Clear, auditable documentation and testing certificates to help your machinery pass national accreditation audits.

AS/NZS IEC 60601

Medical electrical equipment – General requirements for basic safety and essential performance

This international standard dictates the core manufacturing and engineering safety requirements for medical electrical systems.

What we do: During repairs or servicing, we verify that replacement components, performance metrics, and safety barriers remain aligned with the manufacturer's IEC 60601 design specifications. This guarantees predictable and safe device operation during patient treatment.

AS/NZS 3003

Electrical installations – Patient areas of hospitals, medical and dental practices

This standard governs the correct construction, wiring, and electrical layout of facilities where patient treatment occurs. It establishes strict requirements for body-protected and cardiac-protected electrical areas to prevent shock hazards.

What we do: While this standard applies to the facility, your equipment must connect to these specialised zones. We ensure your medical equipment's electrical configurations comply with the requirements of your AS/NZS 3003 patient care areas, maintaining a safe environment.