IEC 60601-1-2: Medical Device EMC Testing

IEC 60601-1-2 Electromagnetic Compatibility (EMC) Testing for Medical Devices along with the new IEC 60601-1-2 4.1

Wherever you are in your development cycle, we can provide EMC testing to meet your compliance needs. From product design to prototype evaluation and pre-compliance to full-compliance testing, our state-of-the-art 3-, 5-, and 10-meter EMC chambers are equipped to evaluate your medical device to requirements within the EMC Directive, including IEC 60601-1-2 and IEC 60601-2-x particular standards.

The new EMC standard for medical devices, IEC 60601-1-2 4.1, was published in September 2020. There will be a transition period where Edition 4.0 can be used, but after that all medical devices will need to meet the 1st Amendment (4.1).

Overview of IEC 60601-1-2 ED.4.1 EMC for Medical Devices
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• ESD Testing
  Electrostatic discharge is capable of causing numerous problems to electronic devices. ESD testing can simulate electrostatic impacts that devices might experience during operation. Electrostatic Discharge Testing from Intertek can determine whether a product is compliant with IEC 61000-4-2 and can help identify ESD-reducing measures for manufacturers.
• EMC Pre-compliance Scans
  Rapidly diagnose and solve problems in a single design cycle in the lab environment with our EMC/EMI diagnostic tool EMxpert. We can provide real-time and highly repeatable identification of problem frequencies, sources, and their physical location.
• Radiated Emissions and Radiated Immunity Testing
  Radiated Emissions Testing measures the strength of the unintentional emissions that your product can generate. Intertek can help identify how large the emissions are and whether they comply or not with the specified limits.

There will be a transition period where Edition 4.0 can be used, but after that all medical devices will need to meet the 1st Amendment (4.1). Download the 4^th edition recorded webinar or get started with 4^th edition by requesting a RMF Review or Pre-scan test.

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.