The First Chromium Coating to Perform and Pass the Tripartite Guidelines Testing for Biocompatibility

ME-92 Operations was the first chrome coating company to perform and pass the Tripartite Guidelines testing for biocompatibility. The current standard is ISO 10993 and the ME-92® Coatings have also successfully passed the requirements for biocompatibility to this standard.

Anti-Microbial Technology Research concluded that the ME-92® Coatings:

• Reduced bacterial adherence
• Facilitated easier cleaning and decontamination
• Maintained the surface integrity after repeated sterilization cycles

ME-92 has met or exceeded the requirements of the following  industry standards for a biocompatible coating: 

ISO Systemic Toxicity Study (ISO 10993-11)

Systemic Toxicity tests evaluate the generalized biological effects on organs and tissues following exposure to medical devices, bio-material, or their extracts. The term systemic implies that the exposure occurs by one route and the toxic substance is carried to distant locations causing an adverse effect. Systemic toxicity is typically evaluated in studies of acute, sub-acute, sub-chronic, and chronic duration based on the device’s intended exposure.

ISO Maximization Sensitization Study (ISO 10993-10)

Sensitization tests are utilized to evaluate the potential of medical devices, bio-materials, or their extracts tissues to cause a sensitizing effect or allergic reaction following exposure. The method selected is based on the type of tissue contact.

ISO Pyrogen Study – Material Mediated (Pyrogenicity) (ISO 10993-11)

Pyrogen testing is performed to detect pyrogenic or fever responses following exposure to a medical device, bio-material, or their extracts.  The pyrogenic response may be due to endotoxin contamination or a “material-mediated” response associated with non-endotoxin materials that can cause a fever response.

Cytotoxicity Study Using The ISO Elution Method (ISO 10993-5)

Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and/or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques.

ISO Intracutaneous Study (ISO 10993-10)

Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes.  The test(s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure or contact.

ASTM Hemolysis (ISO 10993-4)

Hemocompatibility tests are conducted to evaluate the adverse effects of blood-contacting medical devices or bio-materials on blood or blood components. The effects evaluated include adverse reactions such as thrombosis, hemolysis, platelet, leukocyte, and complement activation, and/or other blood-associated adverse events.