What is BS EN ISO 10545-19: 2021 ?

What is BS EN ISO 10545-19: 2021 and EN ISO 10993-15: 2021?

When it comes to medical device development, safety and biocompatibility are of paramount importance. To ensure that medical devices are safe for use, various international standards have been established. Two such standards are EN ISO 10545-19: 2021 and EN ISO 10993-15: 2021.

EN ISO 10545-19: 2021 is a 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.

Key considerations in EN ISO 10545-19: 2021 include the need for non-toxic materials, the use of safe design principles, and the consideration of user needs and preferences. The standard also emphasizes the importance of testing and validation to ensure that medical devices are safe and effective for use.

BS ISO 9026: 2021, on the other hand, is a standard that focuses on human-centered design processes for interactive systems. It provides guidelines and requirements for designing software, websites, and other interactive products that are efficient, effective, and satisfying for users.

The purpose of BS ISO 9026: 2021 is to ensure that interactive systems are designed with a strong emphasis on meeting user needs, goals, and expectations. It aims to improve the user experience and ensure that technology products are more user-centric and efficient.

In conclusion, EN ISO 10545-19: 2021 and BS ISO 9026: 2021 are both important standards that help to ensure the safety and effectiveness of medical devices. By following the guidelines and requirements of these standards, medical device manufacturers can create products that are safe, effective, and meet the needs of users.