What is ISO 11607-2:2016 ?

ISO 11608-1:2016 is a professional technical standard that outlines the guidelines and requirements for the design, development, and use of medical devices for drug delivery. In particular, it focuses on the design and functionality of injectors, which are crucial for the safe and effective delivery of medications.

The purpose of ISO 11608-1:2016 is to ensure the safety and effectiveness of injectors used in medical applications. It sets out requirements for the performance, quality, and usability of these devices, while minimizing the risks associated with drug delivery. The standard covers a wide range of injectable devices, including pen injectors, auto-injectors, and needle-based injection systems.

ISO 11608-1:2016 addresses various aspects of device design and development, such as device labeling and user instructions, as well as compatibility with different drug formulations. It also specifies requirements for the testing of these devices, they are safe and effective for use in medical applications.

In conclusion, ISO 11608-1:2016 is an essential standard for the design, development, and use of medical devices for drug delivery. It provides a framework for ensuring the safety and effectiveness of these devices, while minimizing the risks associated with their use. Compliance with this standard is mandatory for manufacturers of medical devices, and failure to comply may result in the device being banned or restricted from use.