ACCREDITED TESTING of MEDICAL EQUIPMENT
With the proliferation of electro-medical devices, Insidious problems are often associated with the inadequate EMC performance of medical equipment because a malfunction can present serious concerns for patient safety and accurate diagnosis. Electromagnetic Compatibility (EMC) requirements are therefore an integral part of medical equipment regulations. EMC Technologies' NATA endorsed reports are internationally accepted in most countries including:
United States
Australia
Food and Drug Administration (FDA)
Therapeutic Goods Administration (TGA)
Compliance with the standards IEC/EN60601-1-2/AS/NZS 3200-1-2 will generally meet the compliance requirements for most countries. reduce interference to other equipment and will also enhance the immunity of the device to interference from other electronic equipment, including from mobile phones.
In Europe, medical electrical equipment must be CE marked in order to be legally sold in any European Community member state. The Medical Device Directive (MDD) applies and test reports to the following standards will be required:
EN60601-1 (relevant parts) and the collateral EMC standard EN 60601-1-2:2005 Edition 2. (Edition 3 will be applicable in 2011).
EMCT's NATA accredited facilities are unique in Australia. Only testing at EMCT will allow local certification and testing to IEC601-1-2/AS/NZS3200.1.2.
Immunity to IEC601-1-2:2005 Ed.2 (Edition 3 will be applicable in 2011)
IEC/EN 61000-4-3
IEC/EN 61000-4-4
IEC/EN 61000-4-5
IEC/EN 61000-4-6
IEC/EN 61000-4-8
IEC/EN 61000-4-11
Radiated immunity
Fast Transients
High Voltage (HV) Surges
Conducted RF
radiated power frequency magnetic fields
Voltage interruption
Emission to IEC 601-1-2:2005 Ed.2
CISPR 14/EN55014/AS/NZS 1044
IEC/EN 61000-3-2
IEC/EN 61000-3-3
radiated and conducted RF emissions
Harmonic emissions
Flicker/Fluctuations
Testing to the safety requirements of EN601-1-xx will shortly be available
If the product fails the test, EMC Technologies can draw on the experience gained from thousands of EMC fixes to provide the most cost effective and appropriate solution to the problem. EMC Technologies have a proven track record in the investigation and solving of on-site interference problems associated with Medical Imaging and other electro-medical equipment.
Indoor OATS and Multi-Function EMC Test Chamber Commissioned at EMC Technologies Keilor Park
|
|














