Crystal IS announces its Klaran HC UVC LEDs are compliant with ISO 10993-5 Cytotoxicity standard

January 2, 2018

Crystal IS, a leader in developing high performance UVC LEDs, today announced that its Klaran HC UVC LEDs are the first to be verified compliant with ISO 10993-5 Cytotoxicity standard.

Crystal IS is the first UVC LED manufacturer to offer a line of products developed exclusively for the automation of infection prevention in medical devices and ancillary equipment for the healthcare industry. The company’s Klaran HC products have been tested and proven to be biocompatible for use in both Class I and Class II medical devices that require a 510K submittal.

The ISO 10993-5 Cytotoxicity standard is used to determine whether a material contains significant quantities of biologically harmful extractables. Cytotoxicity test methods are used to screen raw materials that may be used in medical devices by providing predictive evidence of material biocompatibility.

Klaran HC UVC LEDs offer a nonhazardous, mercury free UV energy source in a compact, durable package that makes them ideal for integrating disinfection functionality into portable medical devices.

Klaran HC LEDs enable medical device OEMs and designers to integrate disinfection capabilities into smaller portable medical devices. The incorporation of UVC LEDs is ideal for medical devices used in routine clinician care during patient recovery in the hospital, and at home where caregivers may not be adequately trained in manual infection prevention protocols.

The global HAI control market is estimated to reach $33.78 billion USD by 2021, growing at a CAGR of 8.3% according to a recent market survey. The major factors driving this growth are the rising number of surgical procedures as well as the mandatory reporting of, and increased financial penalties tied to HAIs.

Despite widespread implementation of quality improvement initiatives, an estimated $9.8 billion is spent each year treating HAIs, according to a study published in the September 2017 issue of JAMA Internal Medicine. As such, reducing the spread of HAIs remains a top priority for public health officials, hospital administrators and the CDC.

Klaran HC products emit no offensive odor, operate instantaneously, and deliver solid state durability with low power requirements. The devices deliver up to three times greater germicidal performance at 260-270 nm, enabling medical device and equipment manufacturers to integrate single LED solutions which minimize costs while incorporating quantifiable infection prevention capabilities into their products.