EMC Testing and Risk Management

EMC Testing and Risk Management
EMC Testing and Risk Management

It wasn’t long ago that EMC Testing and Risk Management wouldn’t have appeared in the same sentence.  Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) testing has normally been performed to meet the criterion established for a desired label.  Once compliance testing has been passed, it’s off to market.

Medical Equipment Safety Concerns

A modern medical facility is packed with electronic equipment.  Much of this equipment is directly involved with safety critical tasks involving life support, monitoring patient vital signs, and alerting personnel of critical situations.  Other equipment in the environment such as cell phones, microwave ovens, and radio devices can interfere with the normal function of safety critical equipment resulting in unknown or behaviors. 

A list of EMI disturbances in medical devices was released in Interference Technology 2020 Medical EMC Guide.  They include:

  • An ambulance radio interfering with a monitor/defibrillator resulting in death.
  • Failure of renal dialysis equipment due to power input susceptibility.
  • Pacemaker compatibility issues when exposed to 13.56 MHz RFID readers.

Risk Management and IEC 60601-1-2

As a result of incidents of medical equipment susceptibility standard such as IEC 60601-1-2 now require a risk assessment be performed before testing to determine immunity test levels and pass fail criteria.  This analysis must be conducted by the manufacturer.  It should define the essential performance each essential function of the device to be tested against the factors likely to be encountered in the intended environment.  These factors include radiated energy sources, conducted sources, electrostatic discharge, and power fluctuations and disturbances.

After this assessment is performed a list of relevant immunity test methods can be selected at realistic levels can be documented in a test plan.  This test plan, again, is the responsibility of the manufacturer to create.

EMI Risks in Other Applications

Electronics are everywhere.  When they are capable of producing safety risks, EMI testing beyond demonstration of compliance is a consideration.  The braking problems that plagued Toyota in 2010 were caused from EMI.  As vehicles become more densely populated with electronic devices the ability of all devices to coexist becomes more questionable.  Additionally portable devices such as cell phones contribute to a more complex radio environment.

EMI Standard Development

As mentioned at the beginning of this article EMC testing does not typically include risk management.  Most testing is performed to exacting standards that set a fixed level for compliance. 

Because standards lag behind the technologies they seek to regulate it is likely to be sometime until risk assessment is fully embraced by these standards.  In time, however, EMC will have to be embraced as an essential part of quality management to ensure the basic safety of the devices we rely on everyday.

CVG Strategy EMI Consultants

CVG Strategy EMI/EMC consultants can provide susceptibility analysis and recommend appropriate test methodologies for verification a product’s ability to perform as specified in today’s congested spectrum.



Wassenaar Changes to CCL Implemented by BIS

Wassenaar Changes to CCL
Wassenaar Changes to CCL

The Bureau of Industry and Security (BIS) has implemented Wassenaar Arrangement changes to the Commerce Control List (CCL).  These changes were agreed upon in the Wassenaar 2018 Plenary meeting.  The changes to the CCL will place additional controls on the export of certain emerging technologies.  It is therefore important that exporters make themselves aware of these new export controls.

What is the Wassenaar Arrangement?

The Wassenaar Arrangement was formed in July of 1996 to promote regional and international security and stability.  Its forty-two member states have agreed to encourage a greater responsibility in the transfer of conventional arms and dual-use goods.  Participating states are required to report their transfers and denials of goods that fall under the List of Dual-Use Goods and Technologies and the Munitions List.  Enactment of agreed upon guidelines, elements, and procedures are implemented at the discretion of member states policies.

What Changes Have Been Made to the CCL?

The BIS published its final ruling on implementation of Wassenaar Arrangement changes made in 2018 on May 23, 2019 (84 FR 23886).  The ruling went into effect September 11, 2020. 

Resulting changes in the CCL effects five emerging technologies: discrete microwave transistors, continuity of operation software, post-quantum cryptography, underwater transducers designed to operate as hydrophones, and air-launch platforms. As a result revisions have been made to twenty eight Export Control Classification Numbers (ECCNs).  The changes effect the following categories:

  • Category 0-Nuclear Materials, Facilities, and Equipment [and Miscellaneous Items]
  • Category 1-Special Materials and Related Equipment, Chemicals, “Microorganisms”, and “Toxins”
  • Category 2-Materials Processing
  • Category 3-Electronics
  • Category 5-Part 1-”Telecommunications” and Part 2-“Information Security”
  • Category 6-Sensors and Lasers
  • Category 7-Navigation and Avionics
  • Category 8-Marine
  • Category 9-Aerospace and Propulsion

Change the Only Constant in Export Law

The Wassenaar Changes to the CCL are but one example of recent changes to export law.  The International Traffic in Arms Regulations (ITAR) and the Export Arms Regulations (EAR) are under constant change to respond to the security requirements of the United States.  As a result exporters must monitor these changes to remain in compliance.  Failure to meet export regulations can result in fines, debarment (loss of ability to export) and even imprisonment.

CVG Strategy Export Compliance Consultants

CVG Strategy has been helping businesses develop and maintain export compliance programs.  A viable and effective compliance is a requirement for parties dealing in the export of goods.  Our staff can establish tailored processes and procedures to keep your organization on track.  We also offer up to date, engaging training that will keep your team current on export law regulations.