Are single-use medical devices coated?

Yes, many single-use medical devices are coated — especially when performance, sterilization resistance, or biocompatibility is required. Coatings such as biocompatible chromium (like Armoloy ME-92), PTFE, and Parylene are commonly used depending on the application. ME-92 is typically used on reusable surgical tools, but may also be applied to high-performance single-use components requiring ISO 10993 compliance.

Can welded areas of a component be ME-92 coated?

Yes, ME-92 can be applied to welded areas of components, provided the surface is properly prepared to ensure adhesion. The coating uniformly covers complex geometries and bonded seams, making it suitable for assembled or fabricated medical tools.

What are the benefits of biocompatible coatings for surgical instruments?

Biocompatible coatings like ME-92 enhance surgical instruments by reducing friction, resisting corrosion, improving sterilization compatibility, and eliminating risks of irritation, toxicity, or pyrogenic reactions — all critical for patient safety.

Why would a disposable medical instrument be coated?

Disposable medical instruments may be coated to enhance cutting efficiency, ensure temporary biocompatibility, or prevent corrosion during use. When performance and sterility are critical even for single-use items, coatings like ME-92 provide essential protection.

Pyrogen Testing | The Armoloy Corporation

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Understanding Pyrogens and Their Impact

Pyrogens are substances—often microbial contaminants—that can cause fever when introduced into the bloodstream or tissues. In industries like medical device manufacturing, pharmaceuticals, and biotechnology, ensuring that materials do not introduce pyrogens is critical for patient safety.

At Armoloy, we provide biocompatible thin dense chrome coatings that undergo USP Pyrogen Testing to confirm their safety and suitability for medical and surgical applications.

What is a Pyrogen Test?

A pyrogen test evaluates whether a material induces a fever response when introduced into a biological system. ME-92 Operations recently conducted a USP Pyrogen Study on our ME-92-coated 304 stainless steel coupons to verify their nonpyrogenic properties.

The study followed United States Pharmacopeia (USP) guidelines and ISO 10993-11: Biological Evaluation of Medical Devices, which ensure compliance with international safety standards.

medical image used for hemolysis testing media

ME-92 Coating: Proven Nonpyrogenic

In a controlled laboratory setting, the pyrogen test involved:

Extracting the ME-92-coated stainless steel in a sterile 0.9% sodium chloride solution
Injecting the extract intravenously into test rabbits
Monitoring temperature changes over three hours

Results: No Pyrogenic Response

The test concluded that ME-92-coated stainless steel showed no significant temperature increase, meeting USP guidelines for non-pyrogenicity. This confirms that ME-92 coatings do not introduce harmful pyrogens and are safe for use in medical environments.

Why Pyrogen-Free Coatings Matter

Medical devices, implants, and surgical instruments must be free from pyrogen contamination to prevent adverse patient reactions. ME-92’s biocompatible thin dense chrome ensures:

Pyrogen-free surfaces, reducing infection risks
Enhanced corrosion resistance for long-term durability
Biocompatibility, making it ideal for medical and pharmaceutical applications

Other Biocompatibility Standards

Explore more compatibility standards we certify to.

Intracutaneous Testing

Hemolysis Testing

Cytotoxicity Testing

systemic toxicity specimen in beaker test

Systemic Toxicity Testing

At Armoloy, we specialize in biocompatible coatings that meet the highest industry standards. Our USP-tested, non-pyrogenic coatings help manufacturers ensure safety, compliance, and reliability in critical applications.

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USP Pyrogen Study