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Are FDM materials biocompatible? 

aaron pearson
Aaron Pearson April 10, 2020
April 10, 2020

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. 

 

ULTEM™ is a registered trademark of SABIC or its affiliates.

 

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Table 2
Table 2
Table 3
Table 3
Table 4
Table 4
Table 5
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table 6