Additive manufacturing creates a cost effective way for production of patient specific solutions. One example is patient specific orthopedic cutting guides, which are widely used in the orthopedic medical device market. During post processing, the polyamide 11 and 12 materials (PA1101 and PA2200, EOS, GmbH) are exposed to physical, chemical and thermal stresses which can affect the ageing process. This study characterizes the effect of sterilization on mechanical tensile properties, density measurements and size accuracy of a laser sintered part.
Mechanical properties of EOS PA1101 and 2200 were similar between as built and sterilized material. Size accuracy and density measurements did not change for any sterilization method indicating that the accuracy of the as built patient specific guide would be identical to the serialized guide. This is important for the inspection timing of a patient specific guide, since sterilization is often done as the last step of the process. As more applications for laser based 3D printing are introduced to the medical field, it is important to understand the effect common methods of sterilization have on materials used for patient specific cutting guides.
- Describe why sterilization matters in medical devices and the types of sterilization used
- Understand sterilization effects on materials commonly used in patient specific cutting guides
- Recognize the effect of sterilization on mechanical density measurements and size accuracy of a laser sintered parts