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Jun 25, 2020
  • Webinar

Biocompatibility: ISO 10993 Updates and Challenges

ISO 10993-1 standard focuses on the biological evaluation of a medical device or medical device material within the framework of a risk management process.

Biocompatibility Testing

Date & Time

Starts

Jun 25, 2020 11:30am IST

Ends

12:30pm IST

Location

Online

ISO 10993-1, Biological evaluation of medical devices, newly published in October 2018, represents a significant shift from the approach taken in earlier editions, the standard now focuses on the biological evaluation of a medical device or medical device material within the framework of a risk management process. The interpretation of the overall biocompatibility evaluation should be considered in the appropriate benefit-risk context.

From this webinar, you will learn about:

  • Introduction of ISO 10993-1 2018
  • ISO 10993 -1 2018 Major Changes
  • Biological Safety Evaluation
  • Biological Evaluation Plan
  • Biological Evaluation Report
  • Toxicological Risk Assessment- Case study
  • Role of Chemical Characterization - ISO 10993 -18 (2020) updates

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