What is EN ISO 10993-34:2021 ?

EN ISO 10993-23:2021 is a crucial standard for medical device manufacturers, as it helps ensure the safety and effectiveness of medical devices. The standard specifies the procedures for evaluating the potential for skin irritation and delayed-type hypersensitivity when medical devices come into contact with human skin.

Irritation and skin sensitization can occur as a result of various factors, including the materials used in the device, the design and functionality of the device, and the quality control processes in place. By evaluating the potential for irritation and sensitization, EN ISO 10993-23:2021 provides a comprehensive guideline for manufacturers to ensure the safety and well-being of patients.

The standard provides guidelines for conducting various tests, such as the patch test, the irritation test, and the contact angle test. These tests are designed to assess the potential for skin irritation and sensitization when medical devices are in contact with human skin.

EN ISO 10993-23:2021 also provides guidelines for evaluating associated risks and categorizing devices accordingly. This helps manufacturers to identify devices that pose a risk to patients and take appropriate measures to minimize that risk.

Conclusion

In conclusion, EN ISO 10993-23:2021 is a significant standard that helps ensure the safety and effectiveness of medical devices. By evaluating the potential for skin irritation and sensitization, manufacturers can ensure that their products are safe for use and meet the needs of patients. The standard is widely recognized in the medical device industry and is essential for protecting the health and well-being of patients.