What is EN ISO 10993-21: 2021 ?

EN ISO 10993-23: 2021 is a new standard that aims to provide comprehensive guidelines for evaluating the potential risks associated with medical devices and ensuring the safety and well-being of patients. The standard, which builds upon the existing EN ISO 10993-2: 2019, focuses on the assessment of irritation and skin sensitization caused by medical devices.

Irritation and skin sensitization are potential adverse reactions that can occur when medical devices come into contact with the skin. These reactions can cause discomfort, pain, and even adverse health effects. Therefore, it is essential to evaluate the potential for such reactions and ensure that medical devices are safe and well-tolerated by the human body.

EN ISO 10993-33: 2021 provides guidelines for conducting various tests, evaluating associated risks, and categorizing devices accordingly. It also provides requirements for the documentation of testing results and provides guidance on how to determine the appropriate category for a device based on its potential for irritation and skin sensitization.

The standard is designed to be used by medical device manufacturers, clinicians, and regulatory affairs professionals who are involved in the development, testing, and evaluation of medical devices. By following the guidelines and requirements set out in EN ISO 10993-33: 2021, manufacturers can ensure that their medical devices are safe and effective for use, and patients can benefit from safe and effective medical treatments.

ConclusionEN ISO 10993-33: 2021 is an important standard that aims to ensure the quality and safety of medical devices. By following the guidelines and requirements set out in the standard, medical device manufacturers can ensure that their products are safe and effective for use, and patients can benefit from safe and effective medical treatments. It is essential for medical device manufacturers to stay up-to-date with the latest developments and requirements of EN ISO 10993-33: 2021 in order to ensure the safety and well-being of patients.