Siraya Tech Flex TPU 85A and 95A Filaments Achieve ISO Biocompatibility Certification

We are excited to announce that our Flex TPU 85A and 95A filaments have achieved ISO biocompatibility certifications, specifically ISO 10093-5, ISO 10093-10, and ISO 10093-23. This certification ensures that our TPU filaments are safe and reliable for a wide range of applications, providing our customers with confidence and expanding the potential uses of our Flex TPU products.

Certification Documents

You can view the certification documents at the following links:

Applications of Certified Flex TPU 85A and 95A

With these certifications, our Flex TPU 85A and 95A filaments can now be used confidently in several critical applications, including:

  • Medical Devices: Safe for use in non-implantable medical devices and components such as tubing, connectors, and protective covers.
  • Wearable Technology: Ideal for creating comfortable, skin-contact wearables and fitness devices, including smartwatches, fitness tracker bands, and other personal health monitoring equipment.
  • Consumer Products: Suitable for items that come in contact with skin, such as phone cases, watch straps, ergonomic grips, and custom-fit earphones.
  • Sports Equipment: Used in producing durable and flexible sports gear such as mouthguards, protective padding, and flexible joints in athletic footwear.
  • Automotive Components: Applicable in automotive interiors for flexible gaskets, seals, and ergonomic dashboard elements that require biocompatibility and flexibility.
  • Prosthetics and Orthotics: Used in the production of comfortable and skin-friendly prosthetic liners and orthopedic braces, ensuring long-term wear without causing irritation.
  • Fashion and Accessories: Perfect for fashion items that require flexibility and skin contact safety, including belts, wearable accessories, and customized jewelry.

For more information or to place an order, visit the following links:

Understanding the ISO Certifications

ISO 10093-5

This certification assesses the cytotoxicity of materials, ensuring that our TPU filaments do not contain substances that could harm living cells. This is crucial for applications where the material will be in close contact with human skin or tissue.

ISO 10093-10

ISO 10093-10 evaluates the material for irritation and skin sensitization. It confirms that our TPU filaments do not cause allergic reactions or skin irritation, making them safe for wearable devices and other products that are in direct contact with skin.

ISO 10093-23

This standard tests the systemic toxicity of materials, ensuring they are non-toxic when used in their intended applications. This certification is essential for products used in the medical and consumer goods sectors.

We are proud to achieve these certifications and are committed to providing high-quality, safe, and reliable materials for all your 3D printing needs. Thank you for choosing Siraya Tech.


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