Product Safety

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

IEC 60601-1 Third Edition What you need to know For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles has been clarified, the amended standard includes new requirements regarding essential performance, mandates usability... Read More

ATEX Directive 2014/34/EU Replaces 94/9/EC for Explosive Atmosphere Equipment in EU

Due to Europe’s New Legislative Framework, the ATEX Directive 94/9/EC will be replaced by ATEX Directive 2014/34/EU in 2016, for the testing and certification of certain equipment intended for potentially explosive atmospheres in the EU. From the manufacturer perspective, the changes are not significant, as there are no changes to the Essential Health and Safety... Read More

Audio and Video Equipment Must Adhere to EN 60065:2014 for Conformity with Low Voltage Directive

Starting November 17, 2017, all audio, video, and similar electronic apparatus bound for Europe must meet the safety requirements of the 8th edition of EN 60065, published in 2014. EN 60065:2002+A1:2006 +A11:2008+A2:2010 +A12:2011 will cease to be valid as of the November 17, 2017 date of withdrawal (DOW). All existing certificates must be updated to... Read More

Electrical/Electronic Regulatory Requirements for Top 5 Middle East Economies

Driven by vast petroleum resources, many parts of the Middle East are growing rapidly.  Following are the region’s biggest economies (listed largest to smallest), and electrical/electronic regulatory compliance issues for each. Turkey Boasting the largest economy in the Middle East, Turkey is being considered for European Union membership and the EU CE Mark is accepted... Read More

Marijuana Farms Skirt Laws – EMC & Product Safety Laws, That Is

According to a recent article by a San Francisco-area police officer, indoor marijuana grows are proliferating and many of them are illegal.  Due to their frequent use of uncertified equipment that is manufactured overseas with little to no regulatory oversight, there has been a significant amount of radio frequency interference (RFI) that leaves these operations... Read More

Top 12 Facts about CE Marking of Electrical and Electronic Equipment

Earlier this year, the European Commission released the latest references for the harmonized standards used to demonstrate conformity with the EU EMC Directive 2004/108/EC and the new R&TTE Directive 1999/5/EC requirements started on January 1, 2015.  (R&TTE is replaced in June 2016 by the Radio Equipment Directive (RED) 2014/53/EC). Placed on many categories of products,... Read More