IEC 60601-1-2: Medical Device EMC Testing

IEC 60601-1-2 Electromagnetic Compatibility (EMC) Testing for Medical Devices including the NEW IEC 60601-1-2 4th Edition Amendment 1

Wherever you are in your development cycle, we can provide EMC testing to meet your compliance needs. From initial product design to prototype evaluation and pre-compliance through to full-compliance testing, our state-of-the-art 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. Across our vast EMC network, Intertek has 3, 5, and 10 Meter Chambers available to support your testing needs.

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).

IEC 60601-1-2 Ed. 4.1 Overview of Requirements
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• 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.
• ESD Testing
  Electrostatic discharge can cause numerous problems for 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.

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 4th Edition recorded webinar or get started with 4^th edition by requesting a RMF Review or Pre-scan test.

*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.