Tag Archives: medical electrical devices

FAQ: Risk Management for IEC 60601-1

December 21, 2017 Medical Administrator

FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More

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

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 electrical devices

FAQ: Risk Management for IEC 60601-1

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

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About Eurofins | MET Labs

About the MET Mark