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FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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

Inductive Wireless Charging Products Must Comply with These Emissions & SAR Requirements

Manufacturers of new technologies often struggle to determine what electrical compliance regulations apply to their products.  Here is a basic guide for inductive wireless power products, like the wireless mobile phone chargers that are gaining more market penetration. This post is derived from an Intel Corporation presentation given at the recent FCC TCB Council Workshop... Read More

U.S. EPA Announces Criteria for ENERGY STAR Most Efficient 2016

The U.S. Environmental Protection Agency (EPA) has announced final recognition criteria for ENERGY STAR Most Efficient 2016. The ENERGY STAR Most Efficient designation is eligible in 12 product categories: Air Source Heat Pumps and Central Air Conditioners Boilers Ceiling Fans Clothes Washers Dishwashers Computer Monitors Furnaces Geothermal Heat Pumps Refrigerator Freezers Televisions Ventilation Fans Residential... Read More

Gulf Countries Introduce GCC Certification for Safety & EMC of Low Voltage Electrical Equipment

The Gulf Cooperation Council (GCC) Standardization Organization (GSO) has introduced a common Technical Regulation for low voltage electrical products, effective July 1, 2016. This Technical Regulation (BD-142004-01) covers safety and electromagnetic compatibility and will affect seven GCC member states: Saudi Arabia, UAE, Kuwait, Bahrain, Qatar, Oman and Yemen.  It follows a similar existing regulation for... Read More

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

In an effort to remain current with new medical technologies, product safety standard IEC 60601-1 underwent another revision with the 2012 publication of Amendment 1.  More than 100 pages in length, Amendment 1 (Edition 3.1) introduces more than 20 new requirements and 60 modifications to existing requirements for medical devices. For manufacturers of medical electrical... Read More