Tag Archives: medical emc

FDA Adds 4th edition of IEC 60601-1-2 to EMC Consensus Standards List

January 12, 2015 EMC, Medical Administrator

In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems. The complete standard is recognized with the following exception: In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced... Read More

IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes

May 28, 2014 EMC, Medical Administrator

In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements. Dates For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period... Read More

About Eurofins | MET Labs

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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The MET Mark for product safety is accepted throughout the United States & Canada and indicates compliance to federal regulations for safe use in the workplace. 30 years ago, MET became the first OSHA-recognized NRTL (Nationally Recognized Testing Laboratory) in the United States. The NRTL mark is required under federal law for products used in workplaces in all 50 states. MET listed products are also sold in every major retail stores throughout the United States and Canada.

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Tag Archives: medical emc

FDA Adds 4th edition of IEC 60601-1-2 to EMC Consensus Standards List

IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes

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About Eurofins | MET Labs

About the MET Mark