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 speed clearance of FDA 510(k) submissions for respiratory and ventilation devices and accessories.
UL tests respiratory and ventilation devices to the ISO 18562 (Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications) series of standards.
The regulatory approval process for medical devices is complex and not always well defined. UL’s experience helps device manufacturers to provide the data required to efficiently bring products to the marketplace. UL’s in-depth knowledge of the industry uniquely enables us to provide actionable insights to help our customers. Our global presences enables us to offer our customers a full suite of services in their own language and time zone as well as to provide access to local experts.
A world leader in chemical emissions testing, UL has evaluated over 70,000 products and cataloged the presence of more than 10,000 chemicals that those products emit. Our state-of-the-art technology allows us to measure chemicals from a wide range of products with utmost precision.
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 provides additional guidance and standardization for evaluating respiratory and ventilation devices.
This series of standards includes the following four parts:
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, 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.
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