Crystal IS recently announced that its Klaran HC UVC LEDs are the first high performance UVC LEDs to be ISO 10993-5 Cytotoxicity compliant.
The company’s Klaran HC products have previously been tested and proved to be biocompatible to be used in Class I and Class II medical devices that need an FDA 510(k) submittal. Crystal IS also offers products that are made exclusively for automating infection prevention in medical devices and ancillary equipment in the healthcare industry.
ISO 10993-5 Cytotoxicity standard is used for determining if a material has large amounts of biologically harmful extractable. Raw materials that could be used in medical devices are screened in a cytotoxicity test to give evidence of material biocompatibility.
Klaran HC UVC LEDs are a mercury-free, nonhazardous UV energy source designed to be used in portable medical devices because of its compact and durable package. The LEDs allow for medical device OEMs and designers to incorporate disinfection into smaller portable medical devices.
Crystal IS Klaran HC products also have no odor, can operate instantaneously and can deliver solid state durability with low power requirements, according to the company. The devices offer up to three times greater germicidal performance at 260-270 nm.
