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 minimizing cytotoxic and hemolytic risks — all contributing to better performance and 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.

Hemolysis Testing | The Armoloy Corporation

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What is Hemolysis?

Hemolysis is the destruction of red blood cells, leading to the release of hemoglobin into the blood plasma. In medical applications, materials that come into contact with blood must be tested for hemolytic properties to ensure patient safety. Uncontrolled hemolysis can cause serious health complications, including anemia, jaundice, or even renal failure.

At ME-92 Operations, biocompatibility is paramount. That’s why our surface coating underwent hemolysis testing in accordance with ASTM F756 and ISO 10993-4—global standards for evaluating blood-contact materials.

What is a Hemolysis Test?

A hemolysis test assesses whether a material causes red blood cells to rupture when in contact with blood. The test simulates exposure by using anticoagulated whole blood and measuring hemoglobin release with a spectrophotometer. The results are categorized as:

Non-hemolytic if the hemolysis index is <2%
Slightly hemolytic at 2-5%
Hemolytic at >5%

Both direct-contact and extract-based testing are performed to ensure the material’s safety under all relevant conditions.

ME-92 Hemolysis Study Summary

ME-92’s proprietary thin dense chrome coating, applied to 304 stainless steel, was tested by NAMSA, an accredited independent lab. The study included both direct-contact and extract testing using pooled rabbit blood.

Direct Contact Hemolytic Index: 0.7%
Extract Hemolytic Index: 0.0%

Results confirmed that ME-92 is non-hemolytic under both conditions, far below the 2% threshold required for medical-grade safety.

Why Hemolytic Activity Matters

For surgical tools, implants, and devices that interface with blood, biocompatibility isn’t optional—it’s essential. ME-92’s non-hemolytic performance demonstrates its reliability in safeguarding red blood cells and supporting patient health during invasive procedures.

Other Biocompatibility Standards

Explore more compatibility standards we certify to.

Intracutaneous Testing

Pyrogen 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. Contact us to learn how ME-92 can elevate your medical device’s biocompatibility and performance.

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Hemolysis Testing

What is Hemolysis?

What is a Hemolysis Test?

ME-92 Hemolysis Study Summary

Why Hemolytic Activity Matters

Other Biocompatibility Standards

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