Biomedical safety testing

Medical equipment plays a direct role in patient care, so healthcare teams need confidence that every device is safe and performing as intended. Electrical Testing Services (ETS) assesses the electrical safety and essential performance of each item using procedures specific to the equipment type, with results recorded against the individual device so any required action is clear.

AS/NZS 3551Performance verificationIndividual device recordsClass M where required

Biomedical equipment performance verification

Performance verification confirms that the functions required for a medical device to operate safely continue to perform within the specified limits. It complements electrical safety testing and reflects the equipment type, manufacturer information and applicable AS/NZS 3551 management framework. Before testing begins, ETS confirms the scope with the facility, including the functions, accessories and operating modes to be assessed.

Electrical safety analyser on a patient monitor

What biomedical safety testing covers

Inspection, electrical safety and functional checks recorded against each device.

01

Physical inspection

Enclosure, leads, accessories and controls

02

Electrical safety

Matched to the equipment classification

03

Inputs and outputs

The inputs and outputs the device uses

04

Alarms and controls

Alarms, indicators and user controls

05

Protective functions

Checked within the confirmed procedure

06

Performance checks

Against the equipment-specific acceptance criteria

07

Defects and follow-up

Defects, limitations and the follow-up required

Equipment assessed through biomedical testing

Biomedical testing capabilities may include ECG systems, centrifuges and selected X-ray equipment where the relevant approved capability applies. The exact device list should be agreed from the facility asset register before the program begins.

ECG systems

Centrifuges

Selected X-ray equipment

Equipment outside the confirmed procedure or authorisation is identified early so it can be referred to the manufacturer, an approved tester or another suitable specialist.

When equipment should be tested

Acceptance, after repair, routine interval or when performance is uncertain — timed to the equipment management program.

1

Acceptance

Required at acceptance into service — timed to the equipment management program and applicable standard.

2

After repair

Required after repair before equipment returns to clinical use.

3

Routine interval

Required at the scheduled routine interval set by the management program.

4

Uncertain performance

Required when performance is uncertain or a concern is raised.

Why healthcare facilities choose ETS

Specialist personnel, standards alignment, device-level reporting and national delivery under NATA and ISO systems.

Specialist biomedical and healthcare personnel

ETS assigns biomedical technicians and appropriately qualified healthcare electrical personnel to specialist work. Class M inspectors are used where the inspection and jurisdiction require that authorisation.

Testing aligned with healthcare standards

Biomedical equipment and patient treatment areas are assessed against the current standards and procedures relevant to the confirmed scope, including AS/NZS 3551 and AS/NZS 3003 where applicable.

Individual equipment and area reporting

Results are recorded against the specific device, room or protected area. This gives clinical engineering, facility and compliance teams a clear basis for follow-up action.

National systems and coordinated delivery

ETS can coordinate regular electrical testing, specialist biomedical work and supporting property services through one national provider, subject to personnel and service availability.

Accreditation and certified management systems

ETS operates under NATA accreditation for applicable inspection activities and maintains certified systems for quality, safety and environmental management.

We are NATA accredited and ISO triple-certified for quality, safety and the environment.

ISO 17020 · ISO 9001 · ISO 45001 · ISO 14001

NATA accreditedISO 9001ISO 45001ISO 14001JAS-ANZSafe House

Related healthcare pathways

Ask Electrical Testing Services to plan the right checks for your medical equipment

Provide your equipment register and current management records. ETS can confirm the available procedures for each equipment group and build a testing program around clinical access and reporting needs.

1300 30 49 59

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We'll come back with a clear scope and next step.

Or call 1300 30 49 59