MARIETTA, Ga., August 29, 2017 – UL Environment, a division of UL (Underwriters Laboratories Inc.), a global safety science leader, announced today it has launched GREENGUARD Certification for Medical Devices in Breathing Gas Pathways. This latest standard for GREENGUARD Certification was developed to help manufacturers of medical devices that come in contact with breathing gas pathways demonstrate that their products meet the most rigorous emissions limits. In addition, the testing and exposure assessments that are part of the GREENGUARD Certification process can remove potential market access hurdles and help address regulatory concerns related to the US Food and Drug Administration’s (FDA) 510(k) review process.
“These breathing gas pathway medical devices come into contact with people at a particularly vulnerable point and time. As a result, it’s critical that these devices offer minimal exposure to potentially harmful VOCs. GREENGUARD Certification for Medical Devices empowers manufacturers with data and information that allow them to help ensure the safety of their products for human health and speed the 510(k) review process,” said Alberto Uggetti, vice president and general manager of UL Environment. “We are excited to add this to the line of rigorous GREENGUARD Certification standards that help manufacturers in every industry bring safer products to market.”
UL GREENGUARD Certification for Medical Devices includes testing for VOCs, particulates, and leachables in condensate, as well as a complete risk assessment that models expected exposure during use. The GREENGUARD Certification Mark allows medical device manufacturers to signal to buyers that their products meet strict chemical emissions limits, which support human health, even under these vulnerable circumstances.
This certification is based on the ISO 18562 (Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications) series of standards, which are used for evaluating the biocompatibility of medical devices, parts, and accessories, and increasingly looked to by regulators such the FDA.
For more information about GREENGUARD for Medical Devices, visit https://industries.ul.com/environment/certificationvalidation-marks/greenguard-certification-program
About UL Environment
UL Environment works to advance global sustainability, environmental health, and safety by supporting the growth and development of environmentally preferable products, services, and organizations. We help companies achieve their sustainability goals—and help purchasers, specifiers, retailers, governments, and consumers find products they can trust. UL Environment offers environmental claim validations, multi-attribute product certifications, environmental product declarations, indoor air quality certification, product emissions testing, organizational sustainability certification, and consulting. For more information, visit www.ul.com/environment, and connect with us via Twitter, LinkedIn, or Facebook.
UL fosters safe living and working conditions for people everywhere through the application of science to solve safety, security and sustainability challenges. The UL Mark engenders trust enabling the safe adoption of innovative new products and technologies. Everyone at UL shares a passion to make the world a safer place. We test, inspect, audit, certify, validate, verify, advise and train and we support these efforts with software solutions for safety and sustainability. To learn more about us, visit UL.com.