American National Standards Institute [ANSI]

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.

Charged Board Event (CBE) is an electrostatic discharge (ESD) event that can occur on assembled printed circuit boards (PCB) and electromechanic assemblies.

Section 7.3 in ANSI/ESD S20.20–2014 includes a requirement for a product qualification plan.

In this column, we’ll discuss the International Organization for Standardization’s recently published ISO 45001 standard, its parallels with risk communication on products and its implications for workplace safety.

Static control methods may be tested according to industry standards, but additional process risk assessment methods are needed to assure that the static control elements have been successful in mitigating the ESD risks.