PROPRIETARY TITANIUM ANODIZING PASSES ISO TEST
FOR BIOMEDICAL APPLICATIONS
| (CLEVELAND) - Quality standards
for products with biomedical applications demand exceptional scrutiny
of production methods. Because The Electrolizing
Corporation of Ohio specializes in metal finishing for the medical
device industry, the company invests significantly in the quality testing
of its processes. The latest Electrolizing process to undergo rigorous
ISO standards testing is Ti-Med titanium anodizing. Independent testing of Ti-Med coupons was performed by NAMSA within the guidelines of ISO 10993: Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity. NAMSA concluded that, “Under the conditions of this study, the…test extract showed no evidence of causing cell lysis or toxicity.” This cytotoxicity study used the ISO Elution Method (1X MEM Extract). “ Achieving ISO standards is an important part of our commitment to providing the finest, safest and most effective finishing for medical devices,” said Bill Loucks, general manager at Electrolizing. “NAMSA testing for ISO certification is a commitment of time and money, and standards have to be maintained even after the initial certification. But we see it as a part of the services we provide. After all, biomedical applications demand specific, critical assurances and ISO certifications are just that.” The Electrolizing Corporation of Ohio is one of the few metal finishers to offer the very specialized service of titanium anodizing. Titanium anodizing was developed in response to the growing use of titanium in medical parts, medical components and medical instruments. A wide spectrum of bright, sharp colors is possible with Ti-Med. Titanium anodizing is performed to Electrolizing’s own internal Titanium Anodizing Specification: PD-050. Proprietary processes have made The Electrolizing Corporation of Ohio a leader in metal finishing for the medical device industry. Continual research has produced a full range of specialty medical finishes, such as Ti-Med and the revolutionary MEDCOAT 2000™ chrome coating. In addition to testing of its individual processes, The Electrolizing Corporation of Ohio maintains registration to ISO 9001:2008. The Electrolizing Corporation of Ohio was established in 1948 and offers advanced metal finishing, with an emphasis on proprietary and improved processes. |
