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.
The test methods and risk assessment requirements in these standards apply to all medical devices, parts, and accessories that may contact the breathing gas pathway. The scope of products effected by these standards include ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low pressure hoses, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters and Y-pieces as well as many accessories. The enclosed chamber of an incubator, including the mattress and the inner surface of an oxygen hood, are considered to be gas pathways and are also addressed.
In this webinar recording delivered live o June 6th 2017, Sctott Steady, a UL expert in the area of Environmental testing will provide an overview of the series of standards, the scope, testing required and best practices. The recording also includes about 20 minutes of Q&A.
Presenter: Scott Steady, Senior Product Manager, UL Environment
Scott Steady is the Senior Product Manager for UL Environment in Atlanta, GA. He graduated from Louisiana State University with a bachelor’s degree in Chemical Engineering. He has worked as an air quality consultant helping industrial facilities comply with the EPA’s Clean Air Act regulations. For the past 15 years, Scott has been working with product manufacturers to help them understand their products impact on chemical exposure and health. He participated in the development of chemical emissions test methods for UL’s GREENGUARD Certification Program, the BIFMA furniture emissions standards, and many other product related sustainability initiatives.
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