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 article defines ionization qualification and periodic verification test procedures for ionizers which are not addressed in STM3.1 or SP3.3, including air-assist bar ionizers, soft x-ray ionizers, an alternative method of room ionization, and non-airflow alpha ionizers.
The CE marking is also called a “product’s passport” for the markets within the European Economic Area (EU Member States plus Liechtenstein, Iceland and Norway) and in Turkey. It is the first indication that a product complies with the requirements under European Product Law.
Accredited test laboratories, complying with the requirements of ISO/IEC 17025 have to evaluate measurement uncertainty.
Understanding skin effect and surface currents saves us a lot of time and cost in the design of our product’s shielding and filtering, especially for tough EMC standards such as automotive, military or aerospace.
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.
Time and time again the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is Corrective Action & Preventive Action (CAPA). This article explores those challenges and provides the reader with best practices and ways to improve the CAPA process and approach.
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.
It is no trivial matter to properly interpret system level test results on high-speed boards. Board manufacturers (OEMs) assess the ESD robustness of their system by means of gun testing, not always in accordance with the IEC standard.
Car makers are extending the driving range of the electric vehicle to resemble a gasoline-powered car. This requires larger batteries that grow exponentially with the distance driven.