What is EN ISO 10993-13: 2021 ?

EN ISO 10993-15: 2021 is a widely recognized standard in the field of medical device development. The purpose of this standard is to provide guidelines for the assessment of medical devices' toxicity when they come into contact with tissues during normal usage. Specifically, it addresses the potential cytoxicity and genotoxicity of medical devices, aiming to minimize harmful effects on patients and users.

EN ISO 10993-33: 2021 is another important standard related to medical devices. This standard specifies the procedures for the assessment of medical devices with regard to their potential to produce irritation and delayed-type hypersensitivity. In simpler terms, it determines whether a medical device can cause skin irritation or allergic reactions when it comes into contact with human skin.

The use of medical devices is widespread, including in the diagnosis, treatment, and monitoring of health conditions. It is crucial to ensure that these devices are safe and well-tolerated by the human body. Skin irritation and allergic reactions can lead to discomfort, pain, and even adverse health effects. Therefore, evaluating the potential for such reactions is an essential part of quality control in the manufacturing process.

EN ISO 10993-15: 2021 and EN ISO 10993-33: 2021 are just two of the many international standards that medical device manufacturers must comply with to ensure the safety and effectiveness of their products. These standards provide guidelines for manufacturers on how to evaluate the potential for irritation and hypersensitivity when medical devices come into contact with tissues during normal usage. By following these guidelines, manufacturers can minimize the harmful effects on patients and users, ensuring the quality and safety of medical devices.