Now Suitable for Prototyping in Biomedical or Skin Contact Applications

DSM Somos®, a world leader in the development of advanced stereolithography (SL) materials announced USP Class VI approval for their WaterShed® XC 11122 resin—a clear, water-resistant material already widely used in the medical device industry. The classification officially approves the resin for use in a wide range of biomedical or skin contact applications.

Developing advanced biocompatible SL resins for the medical industry is becoming increasingly important. According to Wohler’s Report 2008, the medical/dental industry is the third largest industry for additive manufacturing after consumer products/electronics and automotive, but growing at a faster rate than either. 

“Due to its functional properties and high dimensional stability, WaterShed XC has already been widely used in the medical industry for prototyping clear medical device housings and fluid flow analysis models,” says DSM Somos Product Manager Brian Bauman. “The new USP Class VI approval now opens up new applications, including prototypes to be used in clinical trials.”

Introduced by DSM Somos in 2007, WaterShed XC has quickly become the best-selling clear SL resin on the market, with its winning combination of clarity, durability and high dimensional stability.  By adding the biocompatibility component, medical design engineers now have a way to produce exceptional ABS-like prototypes that are USP Class VI approved.

About USP Class VI Materials:

United States Pharmacopeia (USP) XIX biological tests are designed to provide information on potential biological effects of polymer materials. One of six different classes (I-VI) are assigned to a material, depending on its performance in biological tests. The higher the material class, the more severe and stringent are the tests. WaterShed® XC 11122 has passed the most severe test requirements in order to be qualified as a USP XIX Class VI material.  NOTE: Special cleaning procedures must be used for SL parts used in USP Class VI applications. Contact a DSM Somos® representative to learn more.

Related Information: Cleaning procedures for preparing parts for USP Class VI