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.