What is EN ISO 10993-16: 2021 ?

EN ISO 10993-15: 2021 and EN ISO 10993-33: 2021 are two widely recognized standards in the medical device industry. These standards are designed to ensure the safety and biocompatibility of medical devices, particularly when they come into contact with tissues during normal usage.

EN ISO 10993-15: 2021 is focused on providing 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.

The purpose of EN ISO 10993-15: 2021 is to establish guidelines for the evaluation of medical devices' 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.

EN ISO 10993-33: 2021 is another important 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 designed to determine whether a medical device can cause skin irritation or allergic reactions when it comes into contact with human skin.

The use of these standards is essential in ensuring the quality and safety of medical devices. By evaluating the potential for skin irritation and allergic reactions, medical device manufacturers can minimize the harmful effects on patients and users, ultimately providing better outcomes for patients.

In conclusion, EN ISO 10993-15: 2021 and EN ISO 10993-33: 2021 are crucial standards for ensuring the safety and biocompatibility of medical devices. By evaluating the potential for skin irritation and allergic reactions, these standards can help medical device manufacturers minimize harmful effects on patients and users, ultimately providing better outcomes for patients.