EMC Testing for Medical Devices

EMC testing of medical devices requires a more rigorous approach 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

Standards

We can test to all of the following standards and many others:

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 2004/108/EEC - 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), the appropriate standard is IEC 60601-1-2 edition 2.1, which is equivalent to EN 60601-1-2:2001, A1.

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 human body 
  by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; 

Request a Quotation

If you would like a quote, please complete and return an EMC Questionnaire and Medical Devices Test Plan.

Associated Links

• FDA Website Link