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Urgent update on changing ISO standards: staying on top of the regulations

August 3, 2021
August 5, 2021

1:00 pm EST

The medical device regulatory landscape has never been this dynamic. With recent and proposed changes to ISO standards, increased scrutiny on extractable and leachable protocols in the FDA, and MDR going live, it’s harder than ever to stay informed on what is being required around the world. In this three-day series we will tackle many of these concepts to ensure you are prepared for your regulatory submissions. During the three days we will discuss:

  • The proposed changes to 10993-17, how will toxicity evaluations change and what impacts might these changes have to current extractable and leachable trends.
  • The use of cytotoxicity testing and what can be used with failures in the test
  • The proposed changes to both AAMI TIR12 and AAMI ST98 and how you can be ready for the enforcement of these updated.


Day 1

Title: After E&L: Updates to the Standard for Toxicological Risk Assessment 10993-17

Key takeaways:

  • Fundamental principles of TRA for medical devices will be reviewed
  • Updates to 10993-17 focus include rational exposure estimates
  • The Threshold of Toxicological Concern (TTC) vs the Analytical Evaluation Threshold (AET)

Presenters: Matthew Jorgensen, PhD & Chris Pohl


Day 2

Title: Cytotoxic Reactivity: Understanding the Cause and the Path Forward

Key takeaways:

  • Cytotoxicity test: why do we do it, what it is and what it tells us
  • Known culprits for cytotoxic reactivity
  • How to interpret the data and what additional information is needed to define patient safety

Presenters: Helin Raagel, PhD


Day 3

Title: Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)

Key Takeaways:

  • Updates to sample size and test control requirements in ST98
  • Discussion on the acceptance criteria using statistics for cleaning validations
  • Guidance on disinfection level and patient contact in TIR 12

Presenters: Alpa Patel and Jeralyn Franson