Medical Testing

Testing of Medical Equipment

Technical Management Programs for Medical Devices

Australian Standard AS3551, "A Technical Management Program for Medical Devices" requires that certain devices used in medical practices be tested at least once every 12 months. This testing is more rigourous than the Tagging and Testing required for non-medical devices. AS3551 requires both safety and performance measurement/calibration. BCS Testing Pty. Ltd. carries out an annual testing program in all Eastern States of Australia . The testing program has the following features:

	Tests are conducted to AS3551 standards
	Testing is carried out on-site at a convenient pre-arranged time
	Calibration of equipment is carried out where necessary as part of the testing process
	We provide comprehensive reports suitable for quality certification, audit and insurance
	Repair facilities are available
	Our rates are very competitive

Tests required by the standard

AS3551 describes a Medical Device Management Program that is designed to "optimise the safety, effectiveness, efficiency and economy of diagnostic, theraputic and supporting equipment used for patient care". The standard requires that devices that come into contact with patients are tested at least once every 12 months. The following inspections and tests are mandated:

	Inspection of equipment including plugs and accessories to ensure no live or dangerous moving parts are exposed.
	Protective earth insulation test
	Insulation resistance test
	Earth leakage current test
	Enclosure leakage current test
	Applied part leakage current test
	Mains contact current test for type CF & BF devices only
	Controls, Instrument and Indicators operating correctly
	Tests of critical performance characteristics

More information

For more information about our services, contact us by phone on (04) 3885 9257 or by email to brian@bcstesting.com.au