Many are Armoloy-coated. Although single-use devices will only be utilized once, doctors, dentists, and the patients who rely on them need the item’s performance to be maximized. For many types of medical instruments, that means applying a biocompatible chromium coating.
ISO 10993-4
ISO 10993-4
Hemolysis Testing
Hemolysis Testing Confirms ME-92® Coating is Non-Hemolytic
summary
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.
Frequently Asked Questions
Yes, as long as the weld is machined and blended. This is a positive application to consider since a welded area is very susceptible to corrosion during autoclave.
Biocompatible coatings enhance the durability, safety, and performance of surgical instruments by preventing corrosion and wear while ensuring they remain safe for use in the body. To learn more about the key benefits and differences between coating types like BIO-TDC and ME-92, read our full blog here.
A disposable medical instrument must perform as well as a reusable device and even disposable instruments require autoclave prior to use. Disposable instruments experience galling and dulling of edges during their short usage, but still must perform to a high level. The ME-92® biocompatible coating reduces these undesirable occurrences.
Partner With Us
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.