Tag Archives: emc testing
Navigating EMC Testing: A Helpful Primer
EMC (Electromagnetic Compatibility) testing is crucial for ensuring that your electronic devices can operate as intended in their electromagnetic environment without causing or being affected by electromagnetic interference. EMI (Electromagnetic Interference) occurs when an electronic device’s operation is disrupted by electromagnetic interference from an external source. The Basics of EMC Testing EMC testing is not... Read More
FAQ: Risk Management for IEC 60601-1
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
For ITE KC Approvals in Korea, KN32/KN35 Replacing KN22/KN24
Beginning on January 1, 2016, Korea standards KN32 and KN35 will be replacing KN22 and KN24 for KC EMC approval of IT equipment. After December 31, 2015, KN22/KN24 will no longer be accepted by Korea. For customers with products that have been KN22/KN24 approved previously, no action is required. Permissive change applications using KN22/KN24 reports... Read More
Wireless & Telecom Regulatory Compliance for Top 5 African Economies
This post is an overview of the wireless and telecom compliance requirements for the 5 largest population countries in Africa. As with any electrical product compliance issue, regulations can change rapidly, so check in with MET’s Global Market Access Group for the latest requirements. Nigeria The most populous country in Africa, Nigeria accepts EU R&TTE... Read More
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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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
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
Top 7 Questions about IEC 60601-1-2 4th Edition for EMC Testing of Medical Devices
This Compliance Today post is a follow up to last week’s post on IEC 60601-1 Edition 3.1. Are there safety benefits to the 3rd edition of IEC 60601-1-2 compared to the 2nd? The test levels required by both the 2nd and 3rd editions of IEC 60601-1-2 are the same. The main change was in clause... Read More
Pre-Compliance EMC Testing Saves Cost and Accelerates Speed to Market
You have designed and built a great new electrical product that meets market demands and trumps competitive offerings. You are confident that it doesn’t radiate much energy and is not susceptible to outside interference. Yet when you do final EMC testing, your product fails. This is the nightmare scenario for product designers. Unit redesign and... Read More
EMC Testing Requires Robust Traceability in EMI Measurements
As a leading 3rd party EMC Test Lab, MET Labs maintains a strict ISO/IEC 17025-2005 Quality System. This system includes a set of requirements addressing the subject of traceability of measurement results. Traceability means that the result of a measurement can be related to a national or international measurement standard, and that this relationship is... Read More
Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2014
Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews. IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation... Read More
