EMC Testing for Medical Devices
Testing of medical devices requires a more rigorous approach than 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 |
Standards
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 EU Medical Device Regulation (MDR) 2017/745 - applies to all general Medical Devices and Active Implantable Medical Devices not covered by the Vitro Diagnostics Directive.
Update: The new EU Medical Device Regulation (MDR) 2017/745, was due to replace the two existing directives, the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC on the 25th May 2020.
However with patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year.
Their goal is to have the Parliament and Council adopt the proposal by the end of May. This postponement will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.
• 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.
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