ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation

It is finally here: the long-anticipated ISO 10993-23 was published January 20th, 2021.


The manufacturer is obliged to evaluate each device for potential adverse effects prior to marketing. Some materials used for medical devices have demonstrated skin or mucosal irritation potential. Other materials and their chemical components have not been tested and could therefore induce adverse effects when in contact with human tissue.

The irritation potential of a medical device or its components can be predicted either in vivo or in vitro, if qualified for use with medical devices.

This new document reinforces the animal welfare aspects already mentioned in ISO 10993-2, emphasizing the 3R’s (replacement, reduction, and refinement of animal studies) for the biological evaluation of medical devices. Meaning that in vitro tests have preference over in vivo tests when appropriately validated and providing equally relevant information.

Major shoutout to RhE models: For skin irritation testing of neat chemicals in vitro tests were developed using reconstructed human epidermis. The method was adapted for detection of irritant chemicals in medical device extracts. These RhE models can also detect the presence of irritant chemicals extracted from polymeric materials [polyvinylchloride (PVC) and silicone] commonly used in the manufacture of medical devices. This method was found to be equally sensitive when compared to the human patch testing and intracutaneous rabbit test.

Given the encouraging results from the developed and validated RhE models it is recommended to explore the use of other alternative in vitro models to assess the irritation potential for mucosal or eye epithelial applications.


Preview of the official document:

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials, or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:

  • pre-test considerations for irritation, including in silicoand in vitro methods for dermal exposure;
  • details of in vitroand in vivo irritation test procedures;
  • key factors for the interpretation of the results

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