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Tested to the Highest Standards: FUCHS Lubricants for Medical Applications

Precision in the medical industry for every component, tool and equipment is non-negotiable, and this includes the use of lubricants. Whether used in surgical tools, drug delivery systems, or diagnostic equipment, lubricants can have direct or indirect contact with patients. That’s why FUCHS takes a rigorous, science-based approach to validating the enduring safety of our lubricants for medical applications.

Biocompatible Lubricants You Can Trust

Although the term “medical-grade lubricant” is often used, it’s important to note that there is no universal certification by that name. Instead, the highest standard for safety is biocompatibility testing—especially for applications involving potential patient contact. FUCHS’ NYEMED biocompatible product line is purposefully developed and tested to the highest international standards to eliminate risk wherever possible.

In environments where lubricants may come into direct or indirect contact with patients, such as powered surgical tools, handheld diagnostic devices, or drug delivery systems, ensuring biocompatibility is essential. Risk assessment is critical to mitigate biological reactions. The NYEMED portfolio is compliant with ISO 10993 standards to ensure it meets the strictest safety benchmarks for use in medical contexts.

Our NYEMED lubricants undergo extensive testing to meet ISO 10993 standards that assess biological safety with medical devices and components.

These include:

  • ISO 10993-5: Cytotoxicity (Direct Contact) – Determines if a lubricant is toxic to cells, ensuring that it won’t interfere with biological functions
  • ISO 10993-10: Skin Irritation (Direct Contact) – Assesses the potential for a product to cause irritation when in contact with the skin
  • ISO 10993-11: Acute Systemic Toxicity (Direct Injection) – Evaluates the risks of systemic toxicity in the event of internal exposure

Additionally, our products have been tested for sterilization stability, ensuring their performance remains consistent even after standard sterilization procedures. This further reduces risk in critical healthcare settings. 

Manufacturing and Testing to the Highest Quality Standards

Selection of optimum lubricants for medical applications goes far beyond performance specifications. Factors such as manufacturing consistency, traceability, and compliance with regulatory standards are equally critical in minimizing risk. FUCHS supports these needs through a Quality Management System certified to ISO 13485:2016, which ensures medical device manufacturing meets stringent global standards. FUCHS production processes are carefully controlled and fully documented, enabling traceability and supporting customer audits and regulatory reviews. 

In our advanced R&D laboratories, lubricants are not only developed and tested, but also validated under simulated use conditions to ensure they perform reliably in end-use applications. Additionally, we maintain an ISO 14644-1 Class 7 Cleanroom environment for applications that require a high level of cleanliness, such as those involving sensitive components or sterile processing.

Non-Cytotoxic Metalworking Fluids for Medical Manufacturing

FUCHS also provides approved and effective metal removal and process fluids for medical component and implant manufacturing , FUCHS provides manufacturers with non-cytotoxic metalworking, cleaning, and forming fluids suitable for high-precision applications like turning, milling, grinding, and drilling of medical-grade materials. Compatible with:

  • Titanium and cobalt alloys
  • Chromium-nickel steels
  • Ceramic materials

These fluids are engineered to meet the highest performance and safety standards ensuring compatibility with both the materials and applications used in medical device manufacturing.

When Patient Safety Matters, Trust the Data

For over 30 years, FUCHS has been a trusted partner to leaders in the medical device, pharmaceutical, and advanced manufacturing industries. From early-stage development through post-production support, we provide custom-engineered lubrication solutions designed to meet the complex needs of critical medical applications. With FUCHS, you’re not just choosing a lubricant—you’re choosing a partner dedicated to safety, reliability, and innovation throughout the entire product lifecycle.

Let’s work together to design safer, smarter medical solutions.