Medical device manufacturing often demands significant investment in new materials and processes. To meet the growing needs of this industry, Stratasys Direct has achieved ISO 13485 certification for its Tucson facility. Alongside this achievement, we’re excited to announce the expansion of our material portfolio, offering advanced biocompatible materials to better serve the medical industry and medical device manufacturers.
Loctite® MED413 - A high-performance, biocompatible solution
The first of our newest biocompatible materials is Loctite® MED 413, offered in white & clear, for P3™ DLP applications. Med413 is a high modulus resin material with excellent flexural and tensile properties, providing an ideal balance of stiffness and toughness for medical device applications requiring impact resistance.
Key Features of MED 413:
Temperature Stability: With a heat deflection temperature of 66-70°C at 0.455 MPa and 52-54°C at 1.82 MPa, MED 413 can operate reliably at body temperature without deflection.
Outstanding Finish: The material boasts a smooth finish with a Ra surface roughness as low as 120 μ-in and a minimum feature size of 0.020 in., ideal for medical parts requiring intricate designs and precise aesthetics.
Biocompatibility: MED 413 meets ISO 10993 certifications for cytotoxicity (ISO 10993-5), irritation and skin sensitization (ISO 10993-10), and medical device irritation (ISO 10993-23).
Below is a sample of some of the compelling mechanical properties that MED 413 offers.
| Elongation at Break | 50% |
| Tensile Modulus |
232 ksi |
| Tensile Strength |
5800 psi |
| Impact Strength (notched) |
1.12 ft-lb/in |
| Heat Deflection Temperature |
158 °F |
MED 413 has passed ISO 10993-5: Cytotoxicity, ISO 10993-10: Irritation & Skin Sensitization, and ISO 10993-23 Irritation for Medical Devices.
This combination of durability, thermal stability, and biocompatibility makes MED 413 an excellent choice for high-performance medical devices, including items subject to rigorous physical demands.
The second biocompatible material addition to the Stratasys Direct portfolio is Somos®BioClear™. This clear stereolithography material is designed for exceptional clarity and mechanical performance, offering exceptional surface finish and making it ideal for clear medical models and surgical guides.
Key Features of BioClear:
ABS-Like Properties: With tensile strength exceeding 7,000 psi and over 15% elongation at break, BioClear delivers the strength and ductility required for demanding applications.
Moisture and Chemical Resistance: Featuring low moisture absorption at 0.35%, BioClear resists common solvents, making it well-suited for limited body contact (under 24 hours).
Biocompatibility: BioClear has passed ISO 10993 certifications for cytotoxicity (ISO 10993-5) and irritation and sensitization (ISO 10993-10), as well as USP Class VI testing, ensuring compliance for medical and dental applications.
BioClear has passed the stringent ISO 10993-5: Cytotxicity, ISO 10993-10: Irritation & Sensitization, and USP Class VI testing, which allows BioClear to be used for medical applications such as non-implantable limited body contact (<24 hours) medical and dental applications. This is great for applications like surgical guides because the smooth surface finish and high transparency enhance visibility for surgeons, while maintaining the biocompatibility required for body contact applications.
Highlighted below are the properties of BioClear, which indicates its high tensile strength of over 7000 psi, while maintaining ductility at over 15% elongation at break. The material has a very low moisture absorption at 0.35%, making it great for skin contact because it won’t absorb fluids. The index of refraction is low so if you are using the material for optically translucent surgical guides, your visibility is still maintained.
| Elongation at Break | 15.5% |
| Water Absorption | 0.35% |
| Tensile Strength |
7300 psi |
| Index of Refraction | 1,514 |
| Heat Deflection Temperature |
122 °F |
Med413 and BioClear are excellent additions to Stratasys Direct’s growing portfolio of medical materials that can be utilized in an ISO 13485 certified facility. Below is a short summary of other materials and their biocompatibility performance.
|
Material |
Technology |
ISO 10993-5: Cytotoxicity |
ISO 10993-23: Irritation |
|
Loctite 3843 |
DLP |
Yes |
Yes |
|
Loctite 3172 |
DLP |
Yes |
Yes |
|
Loctite 3955 FST |
DLP |
Yes |
No |
|
Loctite IND 402 |
DLP |
No |
Yes |
Stratasys Direct continues to reinforce its commitment to additive manufacturing innovation for the medical industry. From impact-resistant devices made with MED 413 to clear surgical guides crafted using BioClear, our biocompatible materials deliver performance, compliance, and reliability.
Discover how our certified processes and cutting-edge materials can move your medical device innovations forward. Learn more about Stratasys Direct’s AM solutions for the medical industry today.
