UL Online Readiness Tool Helps Manufacturers Assess Preparedness for Third Edition of IEC 60601-1

NORTHBROOK, Ill., June 6, 2011 /PRNewswire/ -- UL (Underwriters Laboratories), a world leader in advancing safety, announced today the launch of a new online self-assessment tool that allows manufacturers of medical devices to test their readiness for the transition to the third edition of IEC 60601-1, the internationally harmonized safety standard for electromedical equipment.

In the online self-assessment tool, users will respond to a series of questions related to the key factors that influence a company's readiness for the third edition of IEC 60601-1, including the new elements of Risk Management and ISO 14971 required by the standard. At the end of the survey, manufacturers will receive a rating on their ability to meet requirements in the latest version of the document.  Based on the score, the user can download a PDF containing their detailed report and a list of tools and resources customized to meet the manufacturer's current third edition needs.   

"With June 2012 quickly approaching, it is vital that manufacturers consider the extent of the potential changes, and really need to recognize how prepared they are for the transition," said Anil Patel, UL's General Manager for Health Sciences Industry. "The impact this new standard has on the design of medical devices is huge, and UL is doing everything we can to provide additional resources and support in not only transitioning to the third edition, but also working in a global economy where both the second and third editions of IEC 60601 are recognized."

The online readiness tool is one of many resources UL has made available to support the transition through a new web page on UL.com dedicated to the June 2012 transition. Manufacturers have access to tools, white papers, articles, and resources to support their initiatives in meeting the third edition of IEC 60601 transition dates for the EU and Canada in June 2012.  

The United States Food and Drug Administration (FDA), European Union and Health Canada have recognized IEC 60601, 3rd edition and have established transition dates by which manufacturers must demonstrate conformity to the new edition of the standard.  The European Union and Health Canada have both designated June 1, 2012 as the date by which new products must demonstrate conformity to this internationally recognized standard. The FDA has established June 30, 2013 as its date of transition.

To take the online 60601-1, 3rd edition, readiness assessment survey, visit www.ul.com/60601transition

About UL

UL is a premier global safety science company with more than 100 years of proven history. Employing more than 6,800 professionals in over 96 countries, UL is evolving the future of safety with five distinct business units – Product Safety, Environment, Life & Health, Verification and University – to meet the expanding needs of customers and the global public. For more information on UL services, visit www.UL.com.

SOURCE UL

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