The safety of biological evaluation is one important piece of the puzzle to demonstrate the safety of a medical device. ISO 10993-23:2021 is a new standard that specifies procedures for assessing the irritation potential of medical device, materials or their extracts.
ISO 10993-23 evolved out of ISO 10993-10— an assessment of irritation and sensitization. ISO 10993-10 still contains language around skin irritation, but it will eventually be updated to focus on sensitization. One of ISO 10993-23 is most significant advantages is its potential to reduce in vivo irritation testing.
ISO 10993-10 specifically addresses irritation and sensitization testing of medical devices. This standard outlines the methods for assessing the potential of a device to cause irritation or sensitization reactions in the body. However, ISO 10993-23 focuses on testing for genotoxicity, carcinogenicity, and reproductive toxicity of medical devices. This standard provides guidelines for assessing the potential of a medical device to cause gene mutations, cancer, or harm to reproductive health.
The purpose of ISO 10993-23:2021 is to assess the potential of a medical device to cause irritation or sensitization reactions when it comes into contact with human skin. These reactions can range from mild irritation to allergic reactions.
The standard outlines various test methods and strategies that can be used to evaluate the skin irritation and sensitization potential of a medical device. It includes recommendations for both in vitro and in vivo testing, depending on the nature of the device and its intended use.
The irritation potential of a medical device or its components can be predicted either by an in vivo animal irritation test or by in vitro irritation test if qualified for use with medical devices.
In terms of in vitro testing, ISO 10993-23 suggests the use of reconstructed human epidermis (RHE) models or other relevant cell-based assays to assess the potential for irritation and sensitization. These tests can be performed using extracts or direct contact with the device.
In vivo testing involves exposing animals to the device or its extracts to evaluate the potential for skin irritation and sensitization. The standard provides guidance on study design, including the selection of appropriate animal species and the duration of exposure.
Irritation testing is developed specifically to detect skin and mucous membrane irritation potential. Other types of adverse effects, such as sensitization, are generally not predicted by these tests. Historically irritation testing was done on rabbits. For medical devices that are used as implants or external communicating devices, intradermal testing is more relevant in approaching the application and so far, detection of irritation activity and intracutaneous testing.
ISO 10993-23:2021 also emphasizes the importance of considering the clinical relevance and intended use of the medical device when interpreting the results of skin irritation and sensitization testing. It encourages a risk-based approach to determine the acceptability of the device based on the test outcomes.
Overall, ISO 10993-23:2021 is a valuable resource for medical device manufacturers, regulatory authorities, and testing laboratories involved in the biological evaluation of medical devices. It helps ensure the safety and effectiveness of medical devices by providing guidance on assessing their potential to cause skin irritation and skin sensitization.
