EN ISO 10993-17: 2021 is a widely recognized international standard that sets guidelines for the assessment of medical devices' toxicity when they come into contact with tissues during normal usage. The standard aims to minimize the potential cytoxicity and genotoxicity of medical devices. which can cause harm to patients and users.
EN ISO 10993-15: 2021 is one of the most important international standards for medical device development. It is designed to provide a framework for manufacturers to evaluate the potential for skin irritation and delayed-type hypersensitivity of medical devices.
The purpose of EN ISO 10993-15: 2021 is to ensure that medical devices are safe for use and minimize harmful effects on patients and users. The standard specifies 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 evaluates the potential for skin irritation and allergic reactions of medical devices. The standard specifies the procedures for the assessment of medical devices with regard to their potential to produce irritation and delayed-type hypersensitivity.
In conclusion. EN ISO 10993-15: 2021 and EN ISO 10993-33: 2021 are crucial standards for medical device development. They help ensure that medical devices are safe for use and minimize harmful effects on patients and users. By following these standards. manufacturers can ensure that their medical devices are of high quality and are safe for use in a wide range of applications.
Nina She