MicroCare Medical™ Duraglide™ Dry Lubricant Coating is ISO 10993 Certified
Certification helps speed products to market
NEW BRITAIN, CONNECTICUT –October 3, 2012 – MicroCare Medical™ continually seeks ways to save time and money for engineers and manufacturers looking to get products to market. The supplier of advanced cleaners, coatings and lubricants recently announced that its Duraglide™ dry lubricant coatings are ISO 10993 certified. The ISO 10993 test standards are applied to medical devices intended for topical use in clinical indications where the surface or lining may have been breached in order to evaluate local tissue responses. This test standard applies to materials that are solid and non-biodegradable, degradable and/or resorbable, or non-solid, such as porous materials, liquids, pastes and particulates.
Biological evaluation of medical devices is a standard test performed to determine potential toxicity resulting from contact of device component materials with the body. While the MicroCare Medical Duraglide™ dry lubricant coatings have always been biocompatible, they now offer full documentation and certification to the applicable biocompatibility requirements for ISO 10993 as per the International Organization for Standardization (ISO). ISO is the world’s largest developer and publisher of international standards.
“For the engineer or manufacturer who is working to get their new device to market as quickly as possible, this is a game changer,” said Thomas Tattersall, Executive Vice President of MicroCare Medical. “The certification gives them confidence to specify the Duraglide™ coating because they know it will pass the necessary biocompatibility testing.”
“It comes down to saving time and money,” said Jay Tourigny, Senior Vice President for MicroCare Medical. “For some customers, this advance certification can translate into a time savings of over four months.”
Duraglide™ dry lubricant coatings are applied to medical devices to overcome assembly and component movement problems associated with stacked tolerances. They significantly reduce actuation forces to heighten functionality and usability of the finished device. Other benefits include its nonflammable handling, storage and use, excellent materials compatibility, and excellent environmental properties meeting Federal Environmental Protection Agency (EPA) regulations and U.S. EPA Significant New Alternatives Program approval.
Duraglide™ dry lubricant coatings are available custom blended for dip, spray and aerosol applications, and are used on devices or mechanical assemblies destined for the operating room that function outside of the body such as catheters, cutting tools, staplers, hypotubes, and other “surface to surface” complex assemblies.