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Contact: Roger Martin; 612-767-3258

Sterilizer and its accessories have achieved international standards

Friday, November 8, 2013: Sterilucent, Inc. (Minneapolis, MN) announces that it has achieved certification under ISO 13485: 2003, through the notified body BSI Group Americas. The scope of the certification is for the design, manufacture and distribution of sterilizers and sterilizer accessories. 

“This certification demonstrates that Sterilucent’s technologies and processes have achieved the high standards of the International Organization for Standardization,” said Roger Martin, director of operations for Sterilucent. “This is a key milestone on the path towards commercialization of Sterilucent products.”

The company’s first innovation, the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer, is a low-temperature vaporized hydrogen peroxide system designed for use in facilities that deliver healthcare in austere environments, such as combat support hospitals around the world. The sterilizer’s specialized features for austere environments include: a ruggedized design to limit damage due to transportation, low energy requirements, Lumen and Non-Lumen cycles to broaden the types of devices that can be processed, and the specific capability for processing moisture and heat-sensitive devices. In addition, its related consumable products are designed to have a long shelf life, and a full line of sterility assurance consumables and processing accessories is available directly from Sterilucent to assure all the necessary elements for consistent, productive low-temperature sterilization.

ISO 13485: 2003 Cerification