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April 03, 2020

Berkeley Analytical responds to the need for ISO 18562 biocompatibility testing of ventilators, medical respiratory devices and materials – ISO 16000-9, 16000-6

Daily news articles indicate that many companies, including those outside of the medical device field, are stepping up to manufacture, refurbish, repurpose and repair respiratory ventilators that urgently are needed by hospitals to care for the large influx of COVID-19 patients. The US FDA is expediting the approval of these devices under an Emergency Use Authorization order. In the rush to get devices to hospitals, it is imperative that safety standards for the biocompatibility of medical respiratory devices are met. Specifically, the component materials and the devices themselves should be tested for emissions of toxic volatile organic compounds (VOCs) to avoid the possibility of doing harm.

Berkeley Analytical is uniquely positioned to assist with this effort. We have 30 years of experience in testing materials and products for their emissions of toxic volatile organic compounds (VOCs). Our laboratory is equipped with the latest thermal desorption GC/MS instrumentation from Markes International. Additionally, we operate 30 fully instrumented environmental chambers and use Markes micro-chamber-thermal extractor units for rapid screening of materials for VOC emissions. The scope of our ISO/IEC 17025 accreditation includes the applicable standards – ISO 16000-9 for chamber testing and ISO 16000-6 for TD-GC/MS analysis of VOCs. This analytical standard is specified in ISO 18562-3, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 3: Tests for Emissions of Volatile Organic Compounds. ISO 18562-3 is used to test ventilators, accessories and component materials for their emissions of respiratory irritants, sensitizers and carcinogens.

If you are a manufacturer or material supplier working with ventilators or other medical respiratory devices, Berkeley Analytical can quickly respond to your needs for biocompatibility testing and is ready to assist you with:

  • Testing of VOC emissions of ventilators, respiratory devices, & associated components by ISO 18562-3
  • Testing of particulate emissions of devices and components by ISO 18562-2
  • Testing of VOC emissions of materials used to fabricate face masks
  • Organic chemical leachable & extractable studies
  • Evaluations of new materials for biomedical respiratory devices
  • 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.

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