What is EN ISO 10993-28: 2021 ?

EN ISO 10993-23: 2021 is a technical document that provides guidelines for evaluating the potential risks associated with medical devices and ensuring the safety and well-being of patients. The standard is divided into three parts, each covering a different aspect of device safety.

The first part, EN ISO 10993-23: 2021, deals with the assessment of irritation and skin sensitization caused by medical devices. It provides a comprehensive guideline for evaluating the potential risks associated with these devices and categorizing them accordingly. The standard defines irritation as a local reaction to the skin, such as itching, burning, or redness, while skin sensitization refers to an adverse reaction that occurs in the skin, such as blistering or peeling.

The second part, EN ISO 10993-23: 2021, is focused on the evaluation of the potential to produce delayed-type hypersensitivity, also known as delayed-type allergic reactions. This standard is intended to ensure that medical devices are safe for use in a controlled environment and that they do not cause any adverse reactions when in contact with the skin.

The third part, EN ISO 10993-23: 2021, is dedicated to the classification of medical devices based on their potential to cause skin irritation and sensitization. This standard provides a framework for categorizing medical devices into different categories, based on their potential to cause skin irritation and sensitization.

In conclusion, EN ISO 10993-23: 2021 is an essential standard for ensuring the quality and safety of medical devices. By providing guidelines for evaluating the potential risks associated with medical devices and categorizing them accordingly, this standard can help to prevent skin irritation and allergic reactions caused by medical devices. As medical device manufacturers, it is crucial to comply with the guidelines set out in EN ISO 10993-23: 2021 to ensure the safety and well-being of patients.