Gradient Webinar on ISO 18562:2024 – Chemical and Toxicological Strategies

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June 1, 2024

Gradient Hosting Webinar on ISO 18562:2024 – Chemical and Toxicological Strategies

Webinar Date:  Tuesday, June 25 • 1:00-2:00 PM (EST)

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Join Gradient biocompatibility experts, Drs. Alex Gauthier and Rachel Chang, and special guest speaker Corey Campbell, from Legend Technical Services, Inc., in a free webinar that will provide an “Overview of ISO 18562:2024 – Chemical and Toxicological Strategies.”  Recent updates to the ISO 18562 series of standards introduce major changes to the chemical, biological, and toxicological evaluation of gas pathway devices (e.g., ventilators, anesthesia workstations, breathing systems).  This webinar will provide insights on key ISO 18562-1, -2, -3, and -4 standards and their resulting impacts on biocompatibility and related testing strategies.  Topics include:

  • Preparing biological evaluation plans and reports for gas pathway medical devices;
  • Designing testing strategies for evaluating potential patient exposures to particulate matter (ISO 18562-2), volatile organic substances (ISO 18562-3), and leachables in condensate (ISO 18562-4); and
  • Conducting toxicological risk assessment of extractables and leachables, and assessment of particulate matter and volatile gas substances.

Alex G. Gauthier, Ph.D., is a Senior Toxicologist at Gradient who specializes in medical device biocompatibility, toxicological risk assessment, pharmaceutical non-clinical safety assessment, and large animal safety and efficacy studies.

Rachel Chang, Ph.D., DABT, is a Senior Toxicologist at Gradient with expertise in human health risk assessment and developmental toxicology.  She focuses primarily on toxicological risk assessment of extractables and leachables from medical devices, safety assessments of consumer products, and benchmark dose modeling.

Corey Campbell, CHMM, is an Industrial Hygienist at Legend Technical Services, Inc., who conducts design/set-up and testing of medical devices for any contribution of volatile organic compounds, PM2.5/PM10 particulate, and inorganic gases (carbon dioxide, carbon monoxide and ozone).

Register here