UL 60601 & IEC 60601 - 2nd & 3rd editions for Medical Device Safety

Medical testing and certification services for global markets

IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries.   In addition to safety requirements, the standard includes particular standards requirements for functional safety, software, lasers and EMC that can be delivered locally via our own test labs where customers can witness their tests.

3rd Edition - UL options for risk management - your choice

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 Application of Risk Management to Medical Devices.  Although it will require a transition, with the incorporation of risk management requirements in the 3rd edition, companies have the opportunity to introduce new technologies and develop devices that do not fit into the test limits and parameters of the 2nd edition of IEC 60601. 

With UL, companies have the flexibility to have their assessment follow either the IECEE based  "Question Approach", or an ISO 14971 Registration "Audit Approach" for 3rd edition certification, as may be most appropriate for their business needs (volume of Certifications and economies of scale can lead to cost savings).  

As with transition to any new standard, in order to minimize test failures, we recommend companies use UL's proactive review service to fully understand the differences in the standards as they apply to each individual product.  Please contact UL to help determine the best certification option for your product, your markets, and your business.  

UL's new web page dedicated to IEC 60601 3rd edition contains links to tools, white papers, and articles to help you prepare for the June 2012 transition dates, including an online self-assessment test you can take to see how prepared you are for 3^rd edition. Click here to visit UL's 60601 transition webpage and see how ready you are. 

2nd edition

UL will continue to provide testing to the 2^nd edition of IEC 60601 as long as countries continue to recognize it.  For those companies launching global products, it may be necessary to maintain a certified 2^nd edition test report with local country deviations and also a 3^rd edition test report.  UL provides integrated test plans to support global safety requirements.

UL services for IEC 60601 & UL 60601

• Option of using the question based approach or an on-site audit-based approach to demonstrate conformity to IEC 60601-1:2005
• Public and private training to IEC 60601 2^nd and 3^rd editions, differences, ISO 14971 and more
• Gap assessment to IEC 60601 and ISO 14971
• IEC 60601 Proactive Review - Early engagement for both 2^nd and 3^rd edition to support demanding project completion schedules.
• Options for single or dual classification to IEC 60601 2nd and 3rd editions
• Potential for reduced FUS inspections and integrated quality system (ISO 13485 and/or ISO 14971) assessments
• CB Scheme informative test reports, and test certificates
• Assessments to support software, EMC, and home healthcare requirements
• Software certification

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. As the # 1 Issuer of CB Certificates, UL CB reports are widely recognized and accepted at certification agencies around the world.

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 to do testing under the CB Scheme. If you have the equipment and qualified personnel to do testing on site, ask about UL's data acceptance program.

Global Adoption Status

Several countries have already recognized the 3^rd Edition of IEC 60601 and set dates by which they will no longer accept 2^nd edition test reports.  For the latest adoption status - please refer to UL's Industry Report "Major Regulatory Decisions on the Third Edition of IEC 60601-1" on the UL Knowledge Services Thought Leadership pages.

Additional resources

• Article:  "Auditory Alarm Requirements in IEC 60601-1-8 and Risk Management Considerations", Med-Tech Innovation (2011) 
• Dedicated web page for IEC 60601 3rd edition transition
• Download UL's Comprehensive 60601 3rd edition Q&A Release 2 (registration required) Now including Addendum on Power Supplies
• Link to MD&DI Article "A New Perspective on Medical Devices Certification" (May 2010) by UL Program Manager, Mark Leimbeck, PE
• Download your copy of "The 3rd Edition Update" -- Global Status of IEC 60601-1, 3rd Edition, August 2007 version (registration required) (PDF) or visit UL Knowledge Services Thought Leadership page for a copy of the June 2010 "The 3rd Edition Update"
• Link to MD&DI Article: "Regulatory Strategies for the Third Edition of IEC 60601-1" (Sept. 2009), co-authored by Mark Leimbeck, PE
• Download Journal of Medical Device Regulation Article outlining the major changes in IEC 60601-1 3rd Edition, co-written by UL's Harvey Rudolph, Ph.D. (registration required) (PDF)