Nearly one third of 510(k) submissions received by the FDA provided inadequate information regarding device biocompatibility. UL provides testing and compliance assistance for manufacturers to help ensure faster clearance of FDA 510(k) submissions for respiratory and ventilation devices and accessories.
UL provides VOC and particle testing to determine biocompatibility of medical devices. ISO 18562 testing is provided to the FDA as part of the 510(k) submission.
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, the FDA 510(k) submission must include data regarding the biocompatibility of any patient contacting materials (directly or indirectly).
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, nebulisers, 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.
For more information on UL’s ISO 18562 capabilities, please contact us at 1.888.485.4733.
ISO/DIS 18562-1 – Part 1: Evaluation and testing within a risk management process
ISO/DIS 18562-2 - Part 2: Tests for emissions of particulate matter
ISO/DIS 18562-3 - Part 3: Tests for emissions of volatile organic compounds (VOCs)
ISO/DIS 18562-4 - Part 4: Tests for leachables in condensate