Medical Device EMC Testing and Certification

Importance of medical device testing for EMC

Our comprehensive medical device electromagnetic compatibility (EMC) testing and certification services will help you to efficiently meet regulatory requirements and increase global market access.   

EMC testing evaluates a product to determine if it is compatible with its intended electromagnetic environment(s). Will it interfere with other nearby products and/or will it be negatively impacted by other nearby products?

In health care applications electromagnetic incompatibility is not just a nuisance, it is potentially life-threatening. Most global regulatory bodies recognize a product cannot be safe and effective if it is not also compatible with its intended electromagnetic environment.

EMC requirements for medical devices

IEC 60601-1-2  

For medical products, IEC 60601-1-2 fourth edition has significant changes that impact both testing and risk management related to basic safety and essential performance. On Dec. 31, 2018, this standard became mandatory for new product submittals to the U.S. Food and Drug Administration and medical products entering the European Union. This standard requires that risks resulting from reasonably foreseeable electromagnetic disturbance be taken into account in the risk management process and references ISO 14971, Medical Devices – Application of Risk Management to Medical Devices.         

Full compliance testing to global EMC and wireless requirements

• EMC risk management evaluation to IEC 60601-1-2 fourth edition – We can assist with this portion of evaluation even if you decide to use your local EMC lab
• CB certification to IEC EMC and safety standards
• Precompliance services including risk management, test plan and instruction for Use review as part of full IEC 60601-1-2 fourth edition projects
• Preliminary EMC testing services
• GAP analysis – review of existing documentation/reports to latest requirements
• Technical assistance program “rent an engineer” – time with one of our experts
• Wireless global market access (GMA) services
• Telecommunication certification body (TCB) for the U.S. Federal Communications Commission
• Foreign certification body (FCB) for Canada
• Conformity assessment body (CAB) – Notified Body for the European Union
• SAR (specific absorption rate) testing   

Benefits

Our global reach and local presence allow us to deliver innovative, customized solutions to streamline testing and simplify the certification process. Under our GMA program, you can choose to combine your EMC test program with your global product safety certification.

UL Solutions can tailor EMC test methodology and documentation to your own specifications, as well as offer expert advice to help ensure the most efficient use of your time and budget. Leveraging UL Solutions' expertise during the development process can help you avoid costly errors in the design phase and speed time-to-market.

Our automated EMC testing facilities enable us to offer an efficient EMC compliance testing service to meet time-to-market needs. We develop tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles.

Why UL Solutions for medical device EMC testing

Global market acceptance

• 120-year business experience
• Operating in more than 143 countries
• UL Solutions has issued more CB test certificates than any other body
• UL reports and certifications are recognized and accepted around the world
• UL Marks appear on more than 22 billion products globally

Comprehensive testing and certification services

• UL Solutions offers field evaluations, on-site training and can come to you for testing
• Full compliance testing/evaluation to prescans and other preliminary testing
• UL Solutions has engineers that work with you throughout the production lifecycle
• UL Solutions’ engineers average more than 10 years in the industry
• UL Solutions has more than 11 industries business units in the company portfolio

Knowledge of global standards and regulatory requirements

• Covers many markets, i.e., U.S. Food and Drug Administration, Korean Ministry of Food and Drug Safety, European Union  In Vitro Diagnostic, EU Medical Devices Directive
• UL Solutions has helped to set more than 1,600 Standards defining safety, security, quality and sustainability
• UL Solutions engineers work with standards committees, such as Association for the Advancement of Medical Instrumentation, American National Standards Institute and government bodies
• UL Solutions has an FDA-recognized consensus Standard, UL 2900, for cybersecurity

State-of-the-art facilities

• 159 UL Solutions laboratories for testing and certification worldwide
• Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
• More than 10 accredited UL Solutions laboratories around the world
• Semianechoic sites result in virtual zero ambient for optimal test conditions and repeatable results
• Automated EMC testing facilities enabled for efficient EMC compliance testing services to help you meet your speed-to-market needs