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Biocompatibility

The First Chromium Coating Company 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

 

ME92 has met or exceeded the requirements of the following  industry standards for biocompatibility: 

 

ISO Systemic Toxicity Study (ISO 10993-11)

Systemic Toxicity tests evaluate the generalized biological effects to organs and tissues following exposure to a 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.

ME-92® Precision Masking =
Focused Protection

EXECUTIVE SUMMARY:
Certificate of Compliance*

* Full testing data is available on request.

Biocompatible Chromium Coating for Ferrous and Non-Ferrous Metal Surfaces

The ME-92® Coating offers the Industry’s Most Versatile Lineup of Biocompatible Chromium Coating Options for ferrous and non-ferrous metals in three finish options:

THREE FINISH OPTIONS:

  • ME-92 Satin
  • ME-92 Non Reflective
  • ME-92 Platinum

ME-92® SATIN

(shown on left applied to a base of stainless steel) Applied to tens of millions of devices, ME-92® Satin is our standard-bearer finish. As with all our finishes, it is bonded directly to the base material, is highly ductile and will not separate from the base material when twisted, flexed or impacted. Designed to enhance the overall performance of surgical devices; galling and fretting elimination, improved wear resistance, increased surface hardness, arrests corrosion from sterilization and laser marking, non-stick easy to clean surface, biocompatible and looks new after hundreds of uses. Unlike other coatings, removal and reapplication of our ME-92® Satin coating will not affect the base material or surface finish.

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ME-92® NON REFLECTIVE

(shown on left applied to a base of stainless steel) Designed specifically for use in Laparoscopic and Endoscopic surgery procedures, ME-92® Non-Reflective coating reduces high-intensity light reflection and glare while providing the same reliable, biocompatible features of our full product line. Laser marking and repeated sterilization protocols will not degrade the color. Unlike other coatings, removal and reapplication of our ME-92® NR coating will not affect the base material or surface finish.

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ME-92® PLATINUM

(shown on left applied to a base of stainless steel) A highly polished surface deserves a high quality coating. From maintaining cutting edges on polished drills and reamers to sealing and protecting a polished instrument with a tough, durable finish our ME-92® Platinum finish takes polished stainless steel to the next level. Our Platinum finish provides a long-lasting, clean, new appearance for premier devices and instruments. Unlike other coatings, removal and reapplication of our ME-92® Platinum coating will not affect the base material or surface finish.

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Biocompatible Chromium Coating for Aluminum Surfaces

The ALCOAT® Coating offers the Industry’s Most Versatile Lineup of Biocompatible Chromium Coating Options for Aluminum in three finish options:

THREE FINISH OPTIONS:

  • ALCOAT Satin
  • ALCOAT Non Reflective
  • ALCOAT Platinum

ALCOAT® SATIN

(shown on left applied to a base of aluminum) ALCOAT® Satin is our standard-bearer finish. As with all our finishes, it is bonded directly to the base material, is highly ductile and will not separate from the base material when twisted, flexed or impacted. Designed to enhance the overall performance of surgical devices; galling and fretting elimination, improved wear resistance, increased surface hardness, arrests corrosion from sterilization and laser marking, non-stick easy to clean surface, biocompatible and looks new after hundreds of uses. Unlike other coatings, removal and reapplication of our ALCOAT® Satin coating will not affect the base material or surface finish.

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ALCOAT® NR

(shown on left applied to a base of aluminum) Designed specifically for use in Laparoscopic and Endoscopic surgery procedures, ALCOAT® Non Reflective coating reduces high-intensity light reflection and glare while providing the same reliable, biocompatible features of our full product line. Laser marking and repeated sterilization protocols will not degrade the color. Unlike other coatings, removal and reapplication of our ALCOAT NR coating will not affect the base material or surface finish.

Learn More

ALCOAT® PLATINUM

(shown on left applied to a base of aluminum) A highly polished surface deserves a high quality coating. From maintaining cutting edges on polished drills and reamers to sealing and protecting a polished instrument with a tough, durable finish our ALCOAT® Platinum finish takes polished stainless steel to the next level. Our Platinum finish provides a long-lasting, clean, new appearance for premier devices and instruments. Unlike other coatings, removal and reapplication of our ALCOAT® Platinum coating will not affect the base material or surface finish.

Learn More