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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. Electrical and electronic 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), which can lead to potential malfunctioning of medical devices. This can cause inconvenience, and even life threating situations. For these high risk devices a more rigorous approach 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 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 89/336/EEC - sets the requirements for the control of emissions and immunity standards for all electrical and electronic products. • The Medical Devices Directive (MDD) - 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), 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,
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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