EMC Testing for Medical Devices

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 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

Make Contact Image

Make Contact

Talk to our technical team to find out how we can support your project needs

Find Out More

UKAS LogoCE Mark 3 FCClogo ISED - Industry Canada LogoCW - Connecting the Digital World LogoUK 5G Logo CAI LogoRCM MarkEMCTLA Logo

     *Extent of the accreditation is limited by the scope click to view.

RN Electronics - Electromagnetic Compatibility Testing, UK Test Lab - EMC testing for all European and worldwide test standards.

Registered Address: RN Electronics Ltd, Arnolds Court, Arnolds Farm Lane, Mountnessing, Essex, CM13 1UT, UK.

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

©2019 RN Electronics Ltd | Site by DVisions | Design by Luna Branding