Performance & Safety Testing for Accreditation (AS 3551)

U-Tech Medical supports AS 3551 and provides scheduled on-site performance verification and electrical safety testing for medical equipment in clinics, hospitals, and healthcare facilities. Our testing confirms that critical performance functions meet the manufacturer’s design specifications and that equipment is safe for both patients and operators during normal use.

Australian Standards recommend that Responsible Owners of Medical Equipment follow the guidelines outlined in AS 3551:2012 – Management Programs for Medical Equipment. This Standard ensures that medical equipment is appropriately performance-tested and electrically safe throughout its service life.

All testing is conducted in accordance with Australian Standard AS 3551.

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What’s Included in On-Site Testing

Our scheduled on-site testing programs typically include:

1. Critical performance and functional testing

2. Electrical safety testing in accordance with AS 3551

3. Minor corrective actions, where appropriate (e.g. improving earth continuity or replacing mains power cables)

4. Medical Equipment Risk Assessment & Life Expectancy Report (optional)

Note: All testing is performed by highly trained biomedical technicians using dedicated medical equipment analysers, testers, and simulators. These instruments are calibrated annually to NATA-traceable standards and maintained in accordance with our ISO 9001 Quality Management System.

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Medical Equipment Repairs

Medical equipment can deteriorate over time, potentially producing inaccurate data or failing to operate as intended. In many cases, users cannot easily verify whether equipment is continuing to perform accurately, reliably, and within manufacturer specifications.

If a fault is identified during on-site testing, our technician will notify you immediately and provide clear advice on the required corrective action. Faulty equipment can either be:

· Repaired in our workshop, or

· Returned to the original manufacturer or supplier, where appropriate.

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Equipment We Service & Repair

U-Tech Medical repairs and services a wide range of medical equipment, including but not limited to:

· Audiometry equipment

· Autoclaves & sterilisation equipment

· Blood pressure monitors

· Cryotherapy systems

· Defibrillators & resuscitation equipment

· Doppler blood flow systems

· DolorClast shockwave therapy units

· ECGs & Holter recorders

· Electrosurgical units

· Examination lights

· Glucometers

· Infusion & syringe pumps

· Medical lasers

· Nebulisers

· Patient beds, tables & chairs

· Patient scales

· Pulse oximeters

· Refrigeration (blood & vaccine fridges)

· Spirometers

· Suction pumps

· Thermometers

· Treadmills

· Ultrasound imaging systems

· Ventilators

· Vital signs monitors

Frequently Asked Question’s

How often does my equipment need to be tested?

AS 3551 requires a risk-based assessment for each device. This assessment considers:

· Manufacturer’s recommended service intervals

· Likelihood and impact of failure

· Usage levels

· Service history

· Experience with similar equipment

· Statutory requirements

In practice, annual testing is widely adopted as an industry standard for most medical devices.

If my equipment has a manufacturer’s extended warranty, do I still need this testing?

Yes. Manufacturer warranties are separate from AS 3551 management programs. Performance and safety testing is still required, particularly after repairs, servicing, or recalibration.

What happens if my equipment fails testing?

U-Tech Medical will advise the required corrective action and provide repair options, including cost guidance where repair is considered economically viable.

Do I need to purchase a copy of the Australian Standard?

No. Purchasing a copy of AS 3551 is not mandatory. However, if you wish to obtain one, it is available online via SAI Global by searching “AS/NZS 3551”.

How is Medical Equipment Risk & Life Expectancy determined?

Medical devices are routinely inspected and maintained throughout their lifecycle. However, even equipment that passes performance and safety testing may present risks once it exceeds its recommended service life.

As equipment ages:

· Spare parts may become obsolete

· Manufacturers may declare devices non-serviceable or non-upgradeable

· Ongoing use may introduce compliance and liability risks

Our Risk and Life Expectancy Assessment help you make informed decisions about continued use, replacement planning, and compliance obligations.