DSM Somos has announced that two of its best selling materials, WaterShedXC 11122 and ProtoGen 18420, have become the only currently available SL resins to meet ISO 10993 standards for use in medical device applications. The announcement came after Watershed XC 11122, a clear, water-resistant SL resin and ProtoGenTM 18420, a white, ABS-like General purpose resin, received ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitisation and ISO 10993-10 Irritation certifications.

The new ISO certifications underscore the continued growth of DSM Somos as a leading provider of innovative additive fabrication materials for life sciences applications.

“Passing ISO 10993 testing reflects DSM Somos’ commitment to meeting the medical devices industry's demanding quality standards related to biocompatibility,” said DSM Somos Marketing Manager Vince Adams. “This ISO certification also demonstrates that use of Watershed XC 11122 and ProtoGen 18420 contributes to the ability of medical device developers to minimise product development risks and maximise their prototyping confidence."

Implications for the Medical Device Industry
In the 5,000+ companies throughout the world that currently develop medical devices, success is all about speed — that is, the speed in which new and improved devices can be tried, tested, and introduced to the market.

Using traditional prototyping methods that most medical device companies are currently familiar with can take several weeks or even months to create a new prototype.

"Until now, medical device producers have been largely unfamiliar with stereolithography (SL) as a prototyping technology," said Adams, "which is not surprising, given that SL materials have, to this point, only been suitable for limited exposure to the human body and not qualified for biomedical applications. When we explain to these companies that they can now use SL to develop a prototype in a few days vs. 1–2 months, and that it's going to be functional, not fragile, they're pretty excited."

Watershed XC 11122 and ProtoGen 18420 can now be recommended for use in medical device applications that include medical device prototypes, anatomical modelling, investment casting patterns (to produce implantable hip and knee joint replacements), hearing aid device manufacturing and surgical and dental drill guides.