standards

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.

This year, the American National Standards Institute (ANSI) celebrates 100 years of leading the collaborative U.S. standardization system.

How does a standard become the “Standard”?

Many EMC engineers consider the American National Standards Institute (ANSI) C63® Committee on EMC to be the National Committee on EMC for the United States.

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

In an effort to harmonize its medical device quality management system regulations with globally-accepted...

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.

Enter SEMI E176-1017. It places the focus not on limited types of emission from any particular equipment, but on EMI in the overall manufacturing environment and in key locations where it specifically matters.

Beginning with its initial release in 2002, the IEC 62133 family of standards has enabled international harmonization of safety testing for small-format cells and batteries. Since then, the standard has seen a major revision in 2012 and, most recently, a very significant change in 2017. This article will detail those latest changes and their impact on compliance activities.