The elements of a program to deal with pre-sale and post-sale safety issues are well-known. But the specifics of what elements should be used and how by a particular manufacturer are often unknown. Therefore, the most important question that must be answered by any company manufacturing finished products or component parts is “What should my company do and how should I do it?”
The evolution of E and H fields on aircraft struck by lightning is a complex process. An October 2014 in-flight lightning strike is reviewed in this article as an example that inspires a fresh look at how lightning E and H fields should be considered for indirect effects certification.
It is a common misconception that any product that complies with IEC 60950-1 will also comply with IEC 62368-1. A key goal of this article is to help readers of IEC 62368-1 understand the underlying safety concerns that the new requirements are trying to address.
The European Commission, the executive body of the European Union, published its latest “Guide for the EMC Directive.”1 Updated to reflect the 2014 recast of the Directive, the Guide discusses various issues, not least what constitutes “inherently benign equipment” and “custom built evaluation kits.” This article reviews the content of the new Guide, highlighting key changes from the previous edition of the Guide published in 2010.
How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World
This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.
China is the second biggest economy in the world. The strong economic growth of the last decades has lead the country to develop its own quality standardization system. The China Compulsory Certification (CCC) is a system which is comparable, but not identical in terms of standards and requirements to the EU’s CE mark or the FCC’s declaration of conformity in the U.S.
The market for automotive vehicles is growing rapidly in China, especially the market for passenger vehicles. This article provides an overview of the general regulations and new rules that will come into effect.