Aluminum Anodizing Electropolishing Passivation
MEDCOAT 2000
Quality Assurance
Process Validations
Ti-Med Ti-Med 2
Superior Metal Finishing
     
A Revolutionary Validated Coating for Medical Devices
 
MEDCOAT 2000™ - Overview
   


MEDCOAT 2000™ was developed by The Electrolizing Corporation of Ohio specifically to meet the needs of the medical device industry. This process has been tested by an outside medical research organization, and shown to greatly improve the performance and service life of medical devices.

We can apply MEDCOAT 2000™ to most ferrous and some nonferrous metals including copper and brass, though it is most commonly applied to stainless steel alloys. Please contact our application engineers to discuss the feasibility of applying MEDCOAT 2000™ to other metals such as aluminum.

MEDCOAT 2000™, an electroplate process, increases wear resistance, reduces friction, prevents galling and seizing and minimizes corrosion. Unless otherwise specified, MEDCOAT 2000™ is applied directly to the base metal without an intermediate coating. It is applied following completion of all base metal processing, which includes a proprietary surface preparation procedure as part of the MEDCOAT 2000™ process.

 
USP Class VI Biomedical Coating for Medical Devices
     
Examples of our validated medical coating for medical devices
     


The Unique Chemistry of MEDCOAT 2000™ Makes it the Perfect Finish

        • Positive ion bond to metal creates excellent adhesion - no chipping, flaking or peeling.
        • Density of MEDCOAT 2000™ makes it more lubricious.
        • Reduces friction: does not rub away or generate heat.
        • Reduces galling and seizing.
        • Cleaning instruments is quick and easy.
        • Non-magnetic: will not affect any sensitive electronic operating room equipment.
        • Wear resistance is 14 times greater than uncoated stainless steel.
        • Electrical conductivity of MEDCOAT 2000™ is greater than that of stainless steel.
        • Hardness of Rc 68-72: near ceramic hardness.
        • Provides a barrier to nickel exposure.

Medical Device Coating - USP Class VI Certified
    
  USP Class VI Certified
   
  • Acute System Toxicity - No systemic toxicity
  • Intracutaneous Toxicity - No localized tissue reaction
  • Implant Toxicity - No irritation to human tissue
  ISO/Tripartite Tested
   
  • Hemolytic - non-hemolytic
  • Mutagenicity - not mutagenic
  • Pyrogenicty - non-pyrogenic
  • Cytotoxicity - non-toxic to living cells
  • Toxicity - non-toxic
  • Sensitization - non-sensitizing
Testing to the subchronic level has already been completed. MEDCOAT 2000™ is an extensively GLP tested USP class approved coating that exceeds many Tripartite Guidelines and meets many ISP 9000 biocompatibility standards pertaining to subchronic use classifications. Our medical device coating has tested favorably to some of the ISO 10993 biocompatibility standard for medical.
     
Proven Applications of MEDCOAT 2000™

 
Medical Device Coating for Bone Screws
  • All types of surgical and dental instruments
  • Arthroscopic blades
  • Bone saw guides & blades
  • Bone screw taps
  • Broaches & acetabular reamers
  • Cannulas
  • Endoscopic and laprascopic instruments
  • Oscillating orthopedic saw blades
  • Single-pieces curettes, elevators, chisels
  • Tibial stylus assemblies
  • Bone drills
  • Reamers
  • Dental drills
  • Aluminum handles
 


MEDCOAT 2000™ - Application


   
  • Thickness
   

Our medical device coating can be applied with great precision and consistency. Each part drawing should specify the coating thickness dimension and tolerance. Consult one of our sales engineers to establish the proper coating thickness and tolerance. The practical coating range for MEDCOAT 2000™ is 0.00005" to 0.0006" (1.2µ to 15.38µ). Depending upon the thickness specified and the part's quality requirements, the following thickness tolerance can typically be maintained: ±.0001". Coating thickness is measured and can be certified, using fluorescence X-Ray technology. For thicker applications and special conditions, please consult one of our sales engineers.

     
  • Abrasion and Wear Resistance
 
Taber Abrasion Wear Resistance

Taber Abrasion Wear Resistance testing was conducted on MEDCOAT 2000™. Two types of stainless steel were used in these tests: AMS 5511 (low C, 18% Cr, 8% Ni steel: Sheet; AMS for SAE 30304) and AMS 5504 (.15% C, 12.5% Cr steel; Sheet; AMS for SAE 51410). One of each material type was coated with MEDCOAT 2000™ one was coated with conventional hard chrome, the other was uncoated. Testing was performed in compliance with Specification FED-STD-141, Method 6192.1. CS-10 Calibrase Wheels were used. One thousand grams of pressure was used against the test panels. The panels were cleaned with acetone prior to weighing. Results of the testing show a great improvement in wear resistance of the MEDCOAT 2000™ specimens versus the conventional hard-chrome plated specimen and the uncoated specimen.

 
     
  • Surface Finish
   

Application of MEDCOAT 2000™ results in a smooth, fine-grained deposit that is uniform in thickness and appearance. The surface is free of blisters, pits, nodules and porosity. There is minimal edge buildup. It can be applied in a dull non-reflective finish, satin or bright finish.

Samples of our medical device coating show no evidence of discoloration, cracking, flaking, rust, or other change following repeated autoclave exposures. Samples were placed in a heat-resistant dish and subjected to multiple autoclave cycles. Steam exposure was conducted in production type gravity displacement steam sterilization vessels at 250 F (121 C). After every fifth cycle, visual and microscopic inspections were made for discoloration and degradation of the samples. Tests were discontinued because repeated autoclave exposures had no effect on the outer surfaces of the samples.


Ordering Information
   


When submitting parts for processing, clearly specify the basis metal designation, required MEDCOAT 2000™ thickness and tolerance, and accompanying part print that delineates coverage: critical surfaces to be covered by MEDCOAT 2000™, areas not to be covered, and optional areas. To achieve optimum performance and cost-effectiveness, all coating requirements should be reviewed with the Electrolizing Corporation of Ohio prior to processing.

For maximum protection against damage and corrosion, before and after processing, all parts must be properly wrapped, preserved and shipped in suitable containers. Parts need to be free of scale, rust, and corrosion prior to processing. The Electrolizing Corporation of Ohio will remove oil, grease and other preservative materials. We can provide custom packaging to customer specification, so that the product is shipped ready for sterilization and use.