Medical Services

UL 60601 - UL's medical safety testing and certification service

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U.S. Requirements:

UL 60601-1 is the U.S. national standard for safety testing electrical medical devices. UL offers the most convenient and efficient classification service to UL 60601, which includes lasers and EMC that can be delivered locally via our own test labs where customers can witness their tests. The UL mark is the most recognized mark for demonstrating compliance with OSHA requirements in the U.S.

The standard is based on IEC 60601-1 2nd Edition with U.S. national differences. The U.S. national differences are the broadest and most detailed of all the national deviations to IEC 60601-1. The differences are based on a variety of reasons including:

UL requirements for Recognized Components dealing with fire, shock, and safety hazards.
National Electrical Code (NEC) requirements.
Requirements for safety practices.
Requirements for basic safety principles and requirements, the elimination of which would compromise safety for U.S. consumers and users of products. A deviation based on this criterion is identified in UL 60601-1 as a D1 national difference.
National differences that are based on editorial comments or corrections.

Manufacturers marketing medical device products in the US must also obtain clearance by the US FDA. UL can provide a complete, integrated solution that includes testing and certification to UL 60601, FDA 510(k) third party reviews, risk management services, and other regulatory services.

Global Requirements:

IEC 60601 is the internationally accepted standard for medical electrical equipment. As with the U.S., the European Union, Canada, Brazil, and other countries have adopted the 2nd edition of IEC 60601 as a national standard with their national deviations to meet local language, culture, building code, and power grid requirements.

UL can combine test plans to accommodate the requirements of many countries' national deviations. This pre-planning can help save you time and money, eliminating the need for redundant testing. You can then use your UL test report as part of your technical file for submission to the regulatory authorities around the world.

CB Scheme

As the leading medical National Certification Body (NCB), UL can also use your test results to prepare a CB Test Report. In addition, UL can authenticate this report by issuing a CB Certificate, which can be used to apply to other CB Scheme participating countries for local marketing approvals.

Testing on site has many advantages for manufacturers who want to control test schedules, have staff onsite for mitigation purposes, and meet production deadlines. UL can come to your site to conduct witness testing and certify qualified manufacturing sites as CB Test Labs (CBTL). If you have the equipment and qualified personnel to do testing on site, ask about UL's Data Acceptance Program.

3rd Edition

The 3rd Edition of IEC 60601, issued in 2005 is in the process of being adopted by countries and public health organizations globally. The 3rd Edition is very different than the 2nd Edition in that in order to show product conformance, it requires a risk management file and process conforming to ISO 14971, the international standard for Risk Management. For more information on the current status of the 3rd Edition, please refer to our latest updates in the "Additional Resources" section.