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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

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 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.

Associated Links

FDA Website Link

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Registered Company Address:
RN Electronics Ltd

Arnolds Court
Arnolds Farm Lane
Mountnessing
Essex
CM13 1UT, UK

Tel: +44 (0)1277 352219
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UK Registered No: 3051259
VAT Number: GB 475 2328 39

Electromagnetic Compatibility Testing, UK Test Lab - EMC testing for all European EMC test standards and world wide.

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