Linda Chatwin, RAC JD, Senior Customer Solutions Consultant UL LLC & Scott Steady, Senior Product Manager, UL Environment will be presenting “Meeting new FDA Expectations for ISO 18562 VOC and Particle Testing for Medical Devices” on Tuesday, June 6, 2017 at 11 AM EST – 12:15 PM EST. For more information and to register click here.
US FDA 510(k) submissions must include data regarding biocompatibility of any patient contacting materials (directly or indirectly) on all medical devices. For respiratory and ventilation devices, a key component of the biocompatibility evaluation is measuring chemicals and particles that may be released into the breathing gas pathway. Until recently, only general guidance was provided to define how manufacturers should measure and assess biocompatibility of the breathing gas pathway. The new ISO 18562, Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications, series of standards are being formed to provide additional guidance and standardization for evaluating respiratory and ventilation devices.
In this live webinar, UL experts in the areas of Environmental testing and FDA submissions will provide an overview of the series of standards, the scope, testing required and best practices. The webinar will then cover the regulatory submission process and specifically what data FDA expects to see.
Form more information and to register online: Click Here