Ventilator, Face Mask Testing

Ventilator, Biomedical Respiratory Device and Face Mask Testing Services

Ventilator in a hospital roomImmediate Needs

It’s critically important that manufacturers now involved in the rapid production and refurbishment of ventilators for treatment of ICU patients suffering from COVID-19 not ignore safety considerations with respect to the biocompatibility of these devices. Many polymeric materials used in the fabrication of such devices contain and may emit chemicals that have the potential to cause adverse biological responses, such as respiratory irritation and sensitization, when inhaled. To avoid the possibility of doing harm and potential liability, the component materials and the devices themselves should be tested for emissions of tox volatile organic compounds (VOCs). For the same reasons, VOC emission testing should be used to qualify new materials used to fabricate face masks.

Background

On March 24, 2020, the U.S. Food and Drug Administration authorized the emergency use of ventilators, other devices modified for use as ventilators, and associated accessories that it determines meet certain criteria for safety, performance and labeling. Approval is being expedited. However, safety evaluations are still required. Included in the list of required standards is ISO 18562 2017-1 through -5.

ISO 18562-3, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 3: Tests for Emissions of Volatile Organic Compounds, states that all gas pathways from which a patient inspires gas shall be evaluated for VOC emissions subject to a risk management process. Testing, if required, is performed at a time after manufacture that represents the shortest reasonable time that could elapse between manufacture and patient use.

The ISO 18562-3 test requires the use of specialized methods that only a qualified laboratory such as Berkeley Analytical can provide. A clean air stream at controlled airflow rate is passed through a ventilator or ventilator component onto a sorbent-packed tube. The tube is qualitatively and quantitatively analyzed for VOCs by thermal desorption GC/MS following ISO 16000-6. The acceptable total VOC exposure limits for adults are 360 μg/day for the first 24 hours and 120 μg/day for the subsequent 29 days. Individual VOC doses are compared to tolerable exposure level limits for identified and unidentified compounds following the procedures in ISO 18562-1:2017.

Services Offered

Berkeley Analytical is an ISO/IEC 17025 accredited testing laboratory with 30 years of experience in the measurement of VOC emissions from many types of polymeric materials including all categories of interior building materials, furniture components, and medical devices. Our lab is equipped with the latest thermal desorption GC/MS equipment from Markes International, the leading provider of this equipment. We operate 30 environmentally controlled test chambers and use Markes micro-chambers for rapid screening of material emissions. ISO 16000-6 cited in ISO 18562-3 is in the scope of our accreditation as is ISO 16000-9 for chamber testing. Additionally, we have the capability to test materials for leachable and extractable organic contaminants. Exposure and health risk evaluations of materials and devices are performed through our collaborations with highly-regarded toxicology and health consulting organizations.

Berkeley Analytical can quickly respond to your needs and is ready to assist you with:

  • VOC emission testing of ventilators, medical respiratory devices, associated materials & components
  • VOC emission testing of face masks & materials used to fabricate masks
  • Organic chemical leachable & extractable studies
  • Evaluations of new materials
  • Quality control testing of your material supply chain
  • Collaborations with toxicologists on exposure & risk assessments

Contact Us to discuss your testing needs and to request a quote.