Purchasing silicone.

Abstract

Now that CE-marking of medical devices is in force, device manufacturers need to be able to document that they employ the correct materials and components for a particular application. To do this they need to understand exactly what they are purchasing and show that their suppliers possess the necessary product range, technical expertise, and, most importantly, the quality procedures required to assure product integrity. This article sets out some basic definitions of terminology relating to material specification and testing of silicone products.