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Formazione >> Webinar e Formazione Online >> Free Webinar "ISO 10993-10:2021 - Tests for skin sensitization"

Free Webinar "ISO 10993-10:2021 - Tests for skin sensitization"

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Please note that your attendance will be confirmed from the event's organizers.

DATE: February 10, 2022 | 3.30 PM - 4.30 PM CET

OFFICIAL LANGUAGE: English

SUBMISSION LINK: This webinar has reached it's maximum capacity.

The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.

Introduction

ISO 10993-10:2021 has been published recently. This fourth edition cancels and replaces the third edition (ISO 10993-10:2010), which has been technically revised.

The main changes compared to the previous edition are as follows:

  • this document now contains a description of skin sensitization testing only;
  • Annex C on non-animal methods for skin sensitization (formerly Annex D) has been updated;
  • the testing for irritation is now described in ISO 10993-23.

Some materials that are included in medical devices have been tested, and their skin sensitization potential has been documented. Other materials and their chemical components have not been tested and may induce adverse effects when in contact with human tissue. The manufacturer is thus obliged to evaluate each device for potential adverse effects prior to marketing.

An overview of available alternative skin sensitization tests for neat chemicals is given in Annex C. To confirm that they are applicable for evaluation of the skin sensitization potential of medical devices, their assays need to be assessed and validated.

Where appropriate, the preliminary use of in vitro methods is encouraged for screening purposes prior to animal testing. This document presents a step-wise approach, with review and analysis of test results at each stage. Statistical analyses of data are recommended and used whenever appropriate.

This webinar aims to provide valuable insights to achieve a better understanding of the evolution of the ISO 10993-10:2021, for the development of safe products by taking into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience. Thanks to the expertise achieved in developing in vitro testing methods specific examples will be showcased describing the range of success of in vitro testing methods as an alternative to in vivo testing.

Agenda
  • From ISO 10993-10:2010 to ISO 10993-10:2021 & ISO 10993-23:2021
  • The step-wise approach
  • Tests for skin sensitization
  • In vitro alternatives
  • Market-specific considerations
  • Q&A
Speaker Profile

Marco Scaloni
Senior Consultant – Medical Devices at Eurofins Medical Device Testing Italy.