Intertek Announces the Availability of New White Papers on IEC 60601-1 3rd Edition
New publications provide full overview of new and changed requirements.
Boxborough, MA, September 22, 2008 --(PR.com)-- Intertek (LSE: ITRK), a global leader in testing, inspection, and certification, has announced two new white papers to help medical device manufacturers better understand the changes to IEC 60601-1, the international standard for the basic safety and performance of medical electrical equipment. With this insight and knowledge, manufacturers can complete the transition to the 3rd Edition quickly and painlessly.
"IEC 60601-1: Changes from 2nd to 3rd Edition" provides a clause-by-clause overview of the specific changes to the standard's requirements, as well as the latest acceptance status of the 3rd Edition in major global markets.
"Essential Performance and Risk Management for the IEC 60601 Series" delves deeper in to the 'new philosophy' of the 3rd Edition, and reviews the information a test laboratory may expect from the device manufacturer to fulfill the new risk management requirements.
"In many cases, the changes in the 3rd Edition require a whole new way of thinking about product safety compliance," said Bob Burek, Intertek medical technical manager. "Any one change to IEC 60601-1, when taken by itself, is enough of a problem to cause costly delays in getting your device to market. But when taken together, the new risk analysis and essential performance requirements can spell disaster if one is not aware of how to address them."
To download these two whitepapers, visit www.intertek-etlsemko.com/60601papers
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About Intertek’s testing and certification services
The Commercial & Electrical division of Intertek provides testing and certification services, including product safety testing and certification, electromagnetic compatibility (EMC) testing, performance testing, and management systems certification. These services provide global market access to customers in industries such as automotive, building products, electronics, household appliances, lighting, medical devices, and telecommunications. Visit www.intertek-etlsemko.com for further information or to contact your local Intertek office.
About Intertek
Intertek is a leading international provider of quality and safety services to a wide range of global and local industries. Partnership with Intertek brings increased value to customers’ products and processes, ultimately supporting their success in the global market place. Intertek has the experience, expertise, resources and global reach to support its customers through its extensive network of laboratories and offices and over 23,000 people in more than 110 countries around the world. For more information, visit www.intertek.com.
"IEC 60601-1: Changes from 2nd to 3rd Edition" provides a clause-by-clause overview of the specific changes to the standard's requirements, as well as the latest acceptance status of the 3rd Edition in major global markets.
"Essential Performance and Risk Management for the IEC 60601 Series" delves deeper in to the 'new philosophy' of the 3rd Edition, and reviews the information a test laboratory may expect from the device manufacturer to fulfill the new risk management requirements.
"In many cases, the changes in the 3rd Edition require a whole new way of thinking about product safety compliance," said Bob Burek, Intertek medical technical manager. "Any one change to IEC 60601-1, when taken by itself, is enough of a problem to cause costly delays in getting your device to market. But when taken together, the new risk analysis and essential performance requirements can spell disaster if one is not aware of how to address them."
To download these two whitepapers, visit www.intertek-etlsemko.com/60601papers
###
About Intertek’s testing and certification services
The Commercial & Electrical division of Intertek provides testing and certification services, including product safety testing and certification, electromagnetic compatibility (EMC) testing, performance testing, and management systems certification. These services provide global market access to customers in industries such as automotive, building products, electronics, household appliances, lighting, medical devices, and telecommunications. Visit www.intertek-etlsemko.com for further information or to contact your local Intertek office.
About Intertek
Intertek is a leading international provider of quality and safety services to a wide range of global and local industries. Partnership with Intertek brings increased value to customers’ products and processes, ultimately supporting their success in the global market place. Intertek has the experience, expertise, resources and global reach to support its customers through its extensive network of laboratories and offices and over 23,000 people in more than 110 countries around the world. For more information, visit www.intertek.com.
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Intertek
Stacey Corbin
800-967-5352
www.intertek-etlsemko.com
Stacey Corbin
800-967-5352
www.intertek-etlsemko.com
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