NORTHBROOK, Ill., November 13, 2012 - UL (Underwriters Laboratories), a world leader in advancing safety, announced today the launch of a new program that supports manufacturers of medical devices with valid non-UL IEC 60601-1 test reports in transferring to UL with minimal to no repeat testing.
Manufacturers of medical equipment with valid IEC 60601-1 test reports can provide UL with their current test report, 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 60601-1 standard, will document conclusions and the manufacturer can start to place the UL Certification Mark on their medical device immediately.
"The UL brand is among the most recognized safety brands in the U.S. among fire marshals, electrical inspectors and consumers," said Tara Kambeitz, Global Marketing Manager for UL's Health Sciences industry. "These are the 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. In order to be sold in the U.S., medical devices must be approved by the FDA. FDA approval involves a thorough assessment of not only test data, but also the quality system controls and risk mitigation processes to insure 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 FDA will be requiring all submissions to demonstrate compliance with the 3rd edition of IEC 60601-1 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."