What is ISO/TR 16146-8:2016 ?

What is ISO/TR 16146-8:2016?

ISO/TR 16146-8:2016 is a technical standard that outlines the requirements for the design and testing of autoinjectors for medical use. It is designed to ensure the safety, reliability, and quality of these devices, while also providing guidelines for their use.

The primary aim of ISO/TR 16146-8:2016 is to establish a set of requirements for autoinjectors that are consistent and user-friendly. These requirements cover various aspects, such as device compatibility with different medications, accurate dosage delivery, ease of use, reliability, and safety.

Key Requirements of EN ISO 11608-1:2016

ISO/TR 16146-8:2016 provides a framework for manufacturers to develop and manufacture autoinjectors that meet the essential criteria for safety and effectiveness. The standard outlines several key requirements, including:

Compatibility: The standard ensures that autoinjectors are compatible with different medications and can be used for various applications.

Safety: The standard emphasizes the importance of device safety, including the prevention of cross-contamination, the risk of user error, and the stability of the device during use.

Performance: The standard specifies the performance requirements for autoinjectors, including the accuracy and reliability of the dosage delivery system.

Usability: The standard outlines the usability requirements for autoinjectors, such as their design, labeling, and user instructions.

Reliability: The standard specifies the reliability requirements for autoinjectors, including their stability, durability, and resistance to failure.

By adhering to the requirements of ISO/TR 16146-8:2016, manufacturers can develop and manufacture autoinjectors that are safe, reliable, and effective for medical use. This standard provides a comprehensive guide for the design and testing of autoinjectors, ensuring that they meet the essential criteria for their intended use.