ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The regulatory approval process for medical devices is complex and not always well defined. The Food and Drug Administration (FDA) is the federal agency responsible for the regulatory oversight of medical devices in the U.S. Most medical device premarket reviews conducted by the FDA fall under its 510(k) Premarket Notification program. In addition to the device description, equivalent devices, software, and performance testing information FDA has released the new ISO 18562.
US FDA 510(k) submissions must include data regarding biocompatibility of any patient contacting materials 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 the 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 affected 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, mouthpieces, 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 on 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.
