Aaron Pearson
Vice President of Public Relations

Facts to-date.

We’re often asked about the biocompatibility of our FDM materials, and recent events have only accelerated the influx of questions. In an effort to make as much information about biocompatibility readily available, this blog post provides the facts we have to-date.

Stratasys has performed multiple tests to determine biocompatibility and the capability for sterilization for the following materials:

• ABS-M30i – ABS (acrylonitrile butadiene styrene) thermoplastic
• PC-ISO – Polycarbonate thermoplastic (white)
• PC-ISO-T – Polycarbonate thermoplastic (translucent)
• ULTEM 1010 resin – PEI (polyetherimide) thermoplastic

Table 1 below summarizes the results for biological endpoints and testing standards for each material. Table 2 identifies the details of the test coupons. Tables 3 through 6 provide current information about the sterilizability of these materials.

An important fact to remember is that this information represents results on post-printed test coupons (cubes), not on raw thermoplastic pellets or filament. Should you want to produce your own test coupons, we’ve included the protocol for preparing the printer and making the coupons with ABS-M30i and/or PC-ISO material. Access the test procedure here

You can also review the biocompatibility and sterilizability supporting documentation currently available. 

* Controlled refers to the specific printer preparation and cleaning that can be found in the test sample preparation document. This includes post-processing as appropriate.

Table 2
Table 3
Table 4
Table 5