UL Now Accepts IEC Test Data from Outside Sources

UL (Underwriters Laboratories), a manufacturing safety and compliance services company located in Northbrook, Ill., has released a new program that support medical device manufacturers with valid non-UL IEC 60601-1 test reports in transferring to UL with minimal to no repeat testing.

IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission. The 60601-1 designation refers to the general overall standards that must be met.

Manufacturers of medical equipment with any valid IEC 60601-1 test reports can now provide UL with their current test report, and a sample and risk management file. UL expert engineers will review the documents alongside a sample, conduct check tests if necessary, and if all is in compliance with the IEC standard, will document conclusions. The manufacturer can then begin to place the UL certification mark on their medical device immediately.

“The UL brand is among the most recognized safety brands in the United States among dire marshals, electrical inspectors and consumers,” said Tara Kambeitz, global marketing manager for UL’s health sciences business. “These are people who are approving device installation in healthcare facilities, and using devices in home healthcare applications. This program gives manufacturers who have existing UL 60601 test data the option of converting to UL and placing the UL mark on their product without the expense or time required to repeat test data.”

IEC 60601-1 is the internationally harmonized safety standard for electromedical equipment. Of course, in order to be sold in the United States, medical devices must also be approved by the U.S. Food and Drug Administration (FDA). FDA approval assesses both the test data and the quality system controls and risk mitigation processes to ensure the product is safe and effective for its intended use. This rigorous regulatory oversight is required for all medical equipment under the scope of IEC 60601-1, and the FDA will begin requiring all submissions to demonstrate compliance with the third edition of this IEC standard (published in 2005) after June 2013.

“We are actively engaging the industry and recognize the controls device manufacturers must have in place to keep up with regulatory requirements,” said Mark Leimbeck, program manager for UL’s health sciences industry 60601 services. “This understanding allowed us to reconsider the rationale behind validating IEC 60601-1 test data and agree to a new innovative process.”