EMC Services for the Medical Device Industry

TÜV SÜD Product Service provides Electromagnetic Compatibility (EMC) testing and certification services, specific to the medical devices industry, from facilities located throughout the US, Europe and Asia. Staffed with experts and state-of-the-art equipment, TÜV SÜD can test and certify electrical medical devices to many EMC requirements, including the international standard IEC 60601-1-2.

Testing is conducted in state-of-the-art shielded semi-anechoic enclosures, which allows for accurate measurements to be recorded without interference from ambient signals or licensed broadcast signals.

About IEC 60601-1-2
In July 2001, the international standard regarding the EMC characteristics of electrical (electronic) products was released. In January of 2002, in the United States, the Association for the Advancement of Medical Instrumentation (AAMI) in conjunction with the American National Standards Institute (ANSI) adopted and published the new international standard.

The standard, International Electrotechnical Commission (IEC) 60601-1-2:2001, is titled "Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard - Electromagnetic Compatibility - Requirements and Tests." The standard is the second edition and updates the previous version of the same international document, which was released in 1993. The standard reflects the real world environment of medical devices; both for emission criteria and for immunity criteria.

This international standard has also been adopted by the European Union as European Norm (Standard) EN 60601-1-2:2001, which supersedes the previous version, EN 60601-1-2:1993.

Ensure your products meet the requirements of the IEC 60601-1-2 standard by testing with TÜV SÜD America today.

For more information, contact us.