EMC Testing for Medical Devices
Medical Devices testing requires a more rigorous approach than some other products due to the type of environment their placed into. High risk electrical and electronic medical devices can be affected by electromagnetic interference(EMI) which can lead to potential malfunctioning causing inconvenience, and even life threating situations.
RN Electronics offer a comprehensive and well equipped testing service to perform such tests, contact us to discuss the applicable EMC test standards and for advice on the requirements for EMC testing of medical devices.
Medical Testing Capabilities
|Radiated Emissions 10kHz-170GHz||Magnetic Emissions 30Hz-100kHz||Fast Transients (EFT/B) 0.2kV-4.4kV|
|Radiated Immunity 10kHz-18GHz||Magnetic Immunity DC & 16Hz-100kHz||Voltage Dips & Interruptions|
|Conducted Emissions 30Hz-100MHz||ESD 0.2kV-16.5kV||Harmonics <16A|
|Conducted Immunity 30Hz-400MHz||Surges 0.2kV-4.4kV (1.2/50µs)||Flicker <16A|
We can test to all of the following standards and many others:
|Generic||Emissions Standards||Immunity Standards|
|Medical Devices||EN 60601-1-2||EN 60601-1-2|
|IVD Medical Devices||EN 61326-2-6||EN 61326-2-6|
EMC Testing of Medical Devices intended for Europe
CE marking is a legal requirement for medical devices intended for sale in Europe, the directives that specifically apply to medical devices manufacturers are:
• The EMC Directive 2014/30/EU - sets the requirements for the control of emissions and immunity standards for all electrical and electronic products.
• The Medical Devices Directive (MDD) 93/42/EEC - applies to all general medical devices not covered by the Active Implantable Medical Devices
Directive or the In Vitro Diagnostics Directive.
• The Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC - applies to all active medical devices and related accessories intended to
be permanently implanted in humans.
• The In-Vitro Diagnostic Medical Devices Directive (IVDMDD) 98/79/EEC - applies to all medical devices and kits used for examining substances
taken away from the patient to make a diagnosis of patient medical conditions.
EMC Testing of Medical Devices to meet FDA
In the USA Medical Devices require testing to the US Food and Drug Administration (FDA), guidance can be found here.
Request a Quotation
If you would like a quote, please complete the form found here.