Tag Archives: 60601 testing

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

November 18, 2015 EMC, Medical Administrator

The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of... Read More

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

August 24, 2015 Medical Administrator

IEC 60601-1 Third Edition Amendment 1 (Ed. 3.1) What you need to know For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding... Read More

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MET Laboratories, Inc was established in 1959 and has become a global service leader for product approvals and regulatory certification of electrical products in Baltimore, MD. In 1989, MET broke the UL monopoly for product safety testing and certification in the United States and is approved to certify products in over 200 UL standard categories. MET Labs is a service leader and trusted provider of product testing and regulatory certification of electrical products for leading brands and companies in the United States, Europe and worldwide. In 2018, MET joined the Eurofins Scientific network and has become a key component in Eurofins’ product testing portfolio.

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Tag Archives: 60601 testing

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

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About Eurofins | MET Labs

About the MET Mark