Medical Approval for Resin

30th June 2010


DSM Somos Brings Speed, Efficiency to Medical Device Product Development with First Stereolithography Resins to Meet ISO 10993-5 and ISO 10993-10 Medical Standards


DSM Somos, a leading global innovator in the development of high-performance stereolithography (SL) resins, announced today that two of their best selling materials, WaterShed®XC 11122 and ProtoGenTM 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 Sensitization 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," says DSM Somos Marketing Manager Vince Adams.  "This ISO certification also demonstrates that use of Watershed® XC 11122 and ProtoGenTM 18420 contributes to the ability of medical device developers to minimize product development risks and maximize their prototyping confidence."


Implications for the Medical Device Industry

In the 5,000+ companies throughout 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," says 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 ProtoGenTM 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

- Surgical and Dental Drill Guides


About the ISO 10993 Standards:

Materials characterization forms the basis for understanding the composition of a medical device material. It also serves as a means to ensure standardization of materials from one lot of devices to the next. As the harmonization of ISO 10993 standards and FDA requirements proceeds, the methods described is used by the U.S. device industry to a greater and greater extent to aid in the selection of optimal materials and to control the uniformity of medical products.

The biological evaluation of medical devices is currently governed by the set of standards developed by the International Organization for Standardization (ISO) and known as ISO 10993 or, in the United States, by FDA blue book memorandum #G95-1, which is a modification of ISO 10993-1, "Guidance on Selection of Tests." ISO 10993-1 states that "in the selection of materials to be used in device manufacture, the first consideration should be fitness for purpose having regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological, and mechanical properties." Characterisation of medical device materials is thus clearly identified as one of the first steps in their overall evaluation.

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