Blog
FDA Issues Guidance for Integration of RF Wireless Technology in Medical Devices
Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical devices. The guidance is recommended, but not mandatory. FDA said its recommendations cover devices that are implanted or worn on the body, and... Read More
CCC Certification for Product Safety & EMC Required for China Market Entry
China is fast becoming the largest consumer market in the world, and for many products, China Compulsory Certification (CCC) is necessary for manufacturers to tap this market. Certification Bodies There are three main certification bodies (CBs) for electronic equipment: China Quality Certification Center (CQC) – issues all electronic equipment CCC certificates China Information Security Certification... Read More
Amendment 2 of IEC 60950-1 Edition 2 Has a Few Notable Changes from Amendment 1
Amendment No. 2 to IEC 60950-1 Second Edition, Safety of Information Technology Equipment, was published in May 2013. The differences as compared to Amendment 1 (and UL 60950-1 2nd Edition) are mostly minor, but there are a few notable changes. Note that IEC Technical Committee (TC) 108 has made a commitment to limit revisions to... Read More
SAR Testing Exclusion a Function of Proximity to Body, Max Output Power
To determine whether your product needs Specific Absorption Rate (SAR) testing, there are a few items to consider. First, is the device operated within 20cm (7.87”) of the head or body? If no, then SAR does not apply. If yes, then SAR does apply, but testing may be excluded based on the device’s output power.... Read More
U.S. House Calls for HALT Testing of Missile Defense Systems
Last month, a U.S. House of Representatives committee asked the Missile Defense Agency to consider the use of Highly Accelerated Life Testing and Highly Accelerated Stress Screening (HALT/HASS) for identifying possible reliability issues in critical ballistic missile defense (BMD) systems and components. The committee also believes HALT testing can help ferret out unreliable counterfeit parts... Read More
Product Safety Certification to UL 913 for Hazardous Locations Can Be to 5th or 7th Edition
Product safety certification to UL 913 Intrinsically Safe Apparatus and Associated Apparatus for Use in Class I, II, and III, Division 1, Hazardous (Classified) Locations is a unique situation. There are currently two active editions of the standard: 5th and 7th. (The 6th Edition was withdrawn in April 2008 in the sense that the standards... Read More
MKE & RRA Make Regulatory Changes for Electrical Products Sold in Korea
Following are recent electrical product regulatory changes in Korea: Korea’s Ministry of Knowledge Economy (MKE) amended the Electrical Appliances Safety Control Act. From July 1, 2013, built-in power supplies for computers and notebooks (including tablet PCs) are mandatory for KC marking. Korea’s Radio Research Agency (RRA) updated the conformity assessment regulation which comes into effect... Read More
EN 61010-1 3rd Edition Compliance Required in EU by October 2013
Learn about changes in the IEC 61010 3rd Edition to understand the impact of the updated standard on your measurement equipment. Like 60601-1 before it, CENELEC and IEC 61010-1: 2010 – along with CSA and UL 61010-1 Third Edition, 2012 – are moving to Third Edition. 61010-1 is the internationally harmonized safety standard for laboratory, process... Read More
ENERGY STAR Certification of Enterprise Servers to Version 2 Has Begun
For certification of enterprise servers, ENERGY STAR is transitioning from specification version 1.1 to 2.0. Version 2.0 is not officially effective until December 16, 2013, but manufacturers may already have products certified to it. As of August 31, 2013, Certification Bodies like MET Labs will no longer certify new products to version 1.1. Here are... Read More
New Medical Equipment Safety of Interoperability Standard AAMI/UL 2800 Being Developed
This week, MET’s Product Safety Lab Director Rick Cooper is attending a meeting of a newly-convened standards committee in Long Beach, CA to discuss the creation of a new medical equipment safety of interoperability standard(s) tentatively known as AAMI/UL 2800. The meeting is well attended by interested parties consisting of certification agencies like MET Labs,... Read More
