STANDARDS PROJECT UNDER WAY FOR ELECTRONIC DEVICE COMPONENTS

The International Electronics Manufacturing Initiative (iNEMI) has started a "Medical Components Reliability Specifications Project" to develop testing and guidelines for electronic components and circuit boards used in medical devices.

"There are very high expectations for reliability in medical devices, especially implantable devices, and a product's reliability is significantly affected by the components used in that product," Anthony Primavera of Boston Scientific said.

Primavera is the chair of the new iNEMI Medical Technology Integration Group, which counts the standards project as its first activity. "This project will develop specifications for testing medical electronics and will work with the appropriate standards-making body or bodies to implement those specifications."

While medical device manufacturers often require very rigorous testing and validation of components before they can be inserted into the devices, there are currently no widely accepted standards or guidelines. This results in each device manufacturer having to create its own set of requirements for each supplier.

( http://www.fdanews.com/ddl/34_10/ )