What is EN ISO 10993-37: 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 acute and chronic effects, in accordance with ISO 10993-1 and ISO 11095-1;

* provide guidance on the selection of appropriate test procedures for irritation and delayed-type hypersensitivity, including the use of human skin or in vitro testing methods;

* define the terms used in the assessment of medical devices for irritation and delayed-type hypersensitivity.

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

* Medical devices should be tested in accordance with ISO 10993-1 and ISO 11095-1 to determine their potential to produce irritation and delayed-type hypersensitivity;

* Test procedures should be designed to provide a representative and reliable assessment of the potential for irritation and delayed-type hypersensitivity;

* Test results should be interpreted and reported according to the requirements of ISO 10993-1 and ISO 11095-1;

* Medical devices should be labeled to indicate their potential to cause skin irritation or allergic reactions, and the results of their testing should be documented and included in the device's technical documentation.

In conclusion, EN ISO 10993-3: 2021 is an essential standard for ensuring the quality and safety of medical devices. By following the guidelines outlined in this standard, manufacturers can better evaluate the potential for skin irritation and allergic reactions, and ensure that their products meet the highest standards of quality and safety.