What is EN ISO 10993-22:2021 ?

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 10993-33:2021, deals with the assessment of irritation and skin sensitization caused by medical devices. It provides a comprehensive guideline for conducting various tests and evaluating associated risks. The objective of this part is to ensure that medical devices are not likely to cause harm when in contact with human skin.

The second part, EN ISO 10993-32:2021, focuses on the classification of medical devices based on their potential to produce irritation and skin sensitization. It provides a system for categorizing devices according to their risk level, allowing manufacturers to identify and prioritize their safety efforts.

The third part, EN ISO 10993-31:2021, addresses the overall quality management system for medical devices. It provides guidance for the entire manufacturing process, from design and development to testing and labeling. This part is intended to ensure that medical devices are produced in accordance with established quality standards and regulations.

In conclusion, EN ISO 10993-23:2021 is an essential standard for ensuring the quality and safety of medical devices. By following the guidelines provided in this standard, manufacturers can minimize the potential for skin irritation and allergic reactions, ultimately leading to a safer and more effective medical product.