What is EN ISO 10993-15:2021 ?

EN ISO 10993-15:2021 is a widely recognized international standard that focuses 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 ensure that medical devices are safe for use and that their potential to cause harm is minimized. This is achieved by specifying the procedures for the assessment of medical devices with regard to their potential to produce irritation and delayed-type hypersensitivity.

EN ISO 10993-33:2021 is another important international standard that specifies the procedures for the assessment of medical devices with regard to their potential to cause skin irritation or allergic reactions when they come into contact with human skin. This standard is crucial in ensuring the quality and safety of medical devices, as skin irritation and allergic reactions can lead to discomfort, pain, and even adverse health effects.

In conclusion, EN ISO 10993-15:2021 and EN ISO 10993-33:2021 are essential technical standards for medical device development. They ensure that medical devices are safe for use and that their potential to cause harm is minimized. By following these standards, medical device manufacturers can ensure that their products are of the highest quality and are safe for use in the healthcare industry.