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EMC Testing for the Medical market 
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EMC Testing for Medical Devices
We offer comprehensive EMC testing of electronic devices intended for the medical market. Medical devices can be vulnerable to electromagnetic interference (EMI), if the levels of electromagnetic energy in its environment exceed the EM immunity (resistance) to which the device was designed and tested. The different forms of electromagnetic energy that can cause EMI are conducted, radiated, and electrostatic discharge (ESD). EMI problems with medical devices can be very complex, not only from the technical position but also from the view of public health issues and solutions.
A more rigorous approach for these high risk devices is required and RN Electronics is well equipped to perform such tests.
Contact our EMC Test Manager to discuss the applicable EMC Test standards and for advice on the requirements for EMC testing of medical devices. Medical Testing Capabilities
StandardsWe can test to all of the following standards and many others:Generic:
EMC Testing of Medical Devices to meet FDA
In the USA Medical Devices require testing to the US Food and Drug Administration (FDA), ODE Guidance Document 638. This contains additional requirements to the European EN 60601-1-2.
Is your device covered by the medical devices directive? Use these definitions to guide you: ISO Definition of Medical Electrical Equipment - Electrical equipment, provided with not more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision, and which makes physical or electrical contact with the patient, and/or transfers energy to or from the patient, and/or detects such energy transfer to or from the patient. Directive 93/42/EEC Definition of Medical Device - (a) 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:• Diagnosis, prevention, monitoring, treatment or alleviation of disease, • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, • Investigation, replacement or modification of the anatomy or of a physiological process,
• Control of conception, and which does not achieve its principal intended action in or on the
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Questionnaires
Download our EMC Questionnaire available in Excel and PDF versions, by clicking on the icons below:|
Questionnaires |
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FDA Website Link - U.S. Food and Drug Administration