UL Solutions leads in biocompatibility assessment and provides testing and toxicology services for manufacturers to help ensure global compliance for respiratory and ventilation devices and accessories.
We can help you identify necessary testing and compliance requirements in advance to help navigate the information required for U.S. FDA 510(k) clearance and notified body review, minimizing costly delays and respect time to market.
The regulatory approval process for medical devices is complex and not always well-defined. The 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.
Many regulatory submissions provide inadequate information regarding device biocompatibility or fail to provide any biocompatibility data at all. Additional information requests add time to the review process, which slows time to market.
Completing the required testing and exposure assessments in advance may help with U.S. FDA or notified body clearance, minimizing costly delays and time to market.
Medical device testing and exposure assessment to meet ISO 18562
ISO 18562 is a series of standards that outlines the general principles for the evaluation of breathing gas pathways of medical devices used in respiratory care or to supply anesthesia or other substances through the respiratory tract. Testing and evaluation according to ISO 18562 series of standards is required for new 510(k) device submittals to the US FDA, compliance with EU MDR requirements, and to evaluate material changes to existing products.
Our testing (including testing for particulate matter (PM), volatile organic compounds (VOCs), and leachable condensates) and toxicology exposure assessments assess the compliance of medical devices subject to ISO 18562.
Global regulatory requirements
ISO 18562 biocompatibility evaluation
For respiratory and ventilation devices, a key component of the biocompatibility evaluation is measuring volatile organic compounds (VOCs) and particles that may be released into the breathing gas pathway.
The ISO 18562 series of standards includes the following four parts:
- ISO 18562-1 - Part 1 Evaluation and testing within a risk management process
- ISO 18562-2 - Part 2 Tests for emissions of particulate matter
- ISO 18562-3 - Part 3 Tests for emissions of volatile organic compounds (VOCs)
- ISO 18562-4 - Part 4 Tests for leachables in condensate
Medical device products affected
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 includes:
- Anesthesia workstations (including gas mixers)
- Breathing systems
- Oxygen conserving equipment
- Oxygen concentrators
- Low-pressure hoses
- Heat and moisture exchangers
- Respiratory gas monitors
- Respiration monitors
- Breathing tubes
- Breathing systems filters
- And 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.
Benefits of an independent, third-party testing partner
Our medical device team is an industry leader in biocompatibility assessment, providing testing and toxicology services for manufacturers to help ensure global compliance for respiratory and ventilation devices and accessories.
We can help you identify necessary testing and compliance requirements in advance to help ensure quicker U.S. FDA 510(k) clearance, minimizing costly delays and respect time to market.