Revolutionizing Healthcare with M-810: A Fabrica 3D Printing Material from Nano Dimension

A Polymer Material for Innovation in Healthcare

In the ever-evolving landscape of medical technology, the demand for innovative and high-quality materials has never been greater. The recent development of the Fabrica M-810 polymer by Nano Dimension marks a significant milestone in 3D printing for medical applications. This cutting-edge material has recently passed the Cytotoxicity ISO 10993 test, proving its non-toxic nature and suitability for use in healthcare products. Let’s delve into what makes Fabrica M-810 a game-changer and how it is set to revolutionize the healthcare industry.

What is ISO 10993 and Why Does It Matter?

ISO 10993 is a set of international standards that evaluate the biocompatibility of medical devices and materials. These standards are crucial for ensuring that any material used in medical applications does not pose a risk to patient health. The ISO 10993 series covers various biological evaluations, including cytotoxicity, sensitization, and irritation testing, to name a few.

For a material to pass the ISO 10993 cytotoxicity test, it must demonstrate that it does not cause toxic effects on living cells. This is particularly relevant for medical devices that come into direct or indirect contact with the body. Passing the ISO 10993 test is a testament to the high quality and safety of the material, making it a preferred choice for medical manufacturers.

Introducing M-810: A Medical-Grade Polymer

Nano Dimension Fabrica has always been at the forefront of innovation, and the M-810 polymer is no exception. This material has been specifically engineered for use in medical applications that demand biocompatibility, precision, and durability. The M-810’s non-cytotoxic properties, as confirmed by its successful ISO 10993 test results, make it an ideal choice for a range of medical devices.

Applications of M-810 in Medical Devices

The unique properties of M-810 make it suitable for the production of tiny and precise components that are critical in the medical field. Some of the key applications include:

• Cannula: M-810 can be used to create highly precise cannulas, which are essential for various medical procedures such as fluid delivery and sample collection.
• Medical Diagnostics: The polymer’s precision and biocompatibility make it ideal for components used in diagnostic equipment, ensuring accurate and reliable test results.
• Imaging: Components made from M-810 can be utilized in imaging devices, providing high resolution and clear imaging necessary for accurate diagnostics.

Manifolds: The polymer’s durability and non-toxicity are perfect for creating complex manifolds used in medical devices that manage and control fluid flow.

Advancing Towards Official GLP Lab Testing

Nano Dimension Fabrica is committed to ensuring the highest standards of quality and safety for its products. The decision to commence official Good Laboratory Practice (GLP) lab tests for M-810 marks an important step towards full certification. These tests will include further cytotoxicity evaluations, as well as animal testing under ISO 10993 and USP Class VI standards. Upon successful completion, M-810 will be validated for a wider range of medical applications, solidifying its position in the market.

Ongoing Quality Assurance

Quality assurance is a top priority at Nano Dimension Fabrica. Following each production run of M-810, the Quality Assurance (QA) and Research & Development (R&D) teams will monitor specifications using Gas Chromatography Flame Ionization Detection (GCFID). This rigorous process ensures that every batch of M-810 meets the stringent quality standards required for medical applications.

In addition to internal quality control, Nano Dimension Fabrica is also committed to providing comprehensive training for its sales teams and customer care representatives. This training will focus on the delivery of M-810, ensuring that all stakeholders are well-equipped to handle customer inquiries and orders efficiently.

A new Cornerstone in Medical Applications

The introduction of M-810 by Nano Dimension Fabrica represents a significant advancement in 3D printing materials for medical applications. With its proven biocompatibility and precision, M-810 is poised to set new standards in the industry, enabling the production of safe, reliable, and innovative medical devices. As the company continues to move forward with rigorous testing and certification processes, M-810 is set to become a cornerstone of medical material innovation, paving the way for a healthier future

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