What is EN ISO 10993-32:2021 ?

EN ISO 10993-3:2021 is a standard that specifies the procedures for the assessment of medical devices with regard to their potential to produce irritation and delayed-type hypersensitivity. It is important to ensure that medical devices are safe and well-tolerated by the human body, as skin irritation and allergic reactions can lead to discomfort, pain, and even adverse health effects.

The standard is part of a series developed by the International Organization for Standardization (ISO) to ensure the safety of medical devices. Specifically, EN ISO 10993-3:2021 focuses on the biological evaluation of medical devices in accordance with ISO 10993-1.

The scope of EN ISO 10993-3:2021 includes the following:

* evaluate the potential to produce irritation, including delayed-type hypersensitivity, in accordance with ISO 10993-1 and other relevant harmonized standards

* determine the threshold limit values (TLVs) for the different types of irritation

* evaluate the potential to produce allergic reactions in accordance with ISO 10993-2 and other relevant harmonized standards

* determine the appropriate testing methods for determining the potential to produce irritation and delayed-type hypersensitivity

* establish the procedures for the collection, documentation, and reporting of data related to the evaluation of medical devices for potential to produce irritation and delayed-type hypersensitivity.

The requirements of EN ISO 10993-3:2021 are as follows:

* Medical devices must be evaluated for their potential to produce irritation and delayed-type hypersensitivity in accordance with ISO 10993-1 and other relevant harmonized standards.

* The results of the evaluation must be documented and reported in accordance with the procedures established in EN ISO 10993-3:2021.

* Test methods for evaluating the potential to produce irritation and delayed-type hypersensitivity must be appropriate and documented.

* Appropriate safety measures must be implemented to prevent or mitigate the risk of skin irritation and allergic reactions resulting from the evaluation of medical devices.

Conclusion

In conclusion, EN ISO 10993-3:2021 is an essential standard for ensuring the quality and safety of medical devices. The standard provides guidance on evaluating the genotoxicity, carcinogenicity, and reproductive toxicity of medical devices and establishes procedures for the assessment of their potential to produce irritation and delayed-type hypersensitivity. By following the guidelines set out in EN ISO 10993-3:2021, manufacturers of medical devices can ensure that their products are safe and well-tolerated by the human body.