What is BS EN ISO 10705-1: 2015 ?

EN ISO 11608-1: 2016 is a professional technical standard that sets out guidelines and requirements for the design, development, and use of medical devices for drug delivery. The standard specifically focuses on the design and functionality of injectors, which are used to deliver various medications to patients.

The purpose of EN ISO 11608-1: 2016 is to ensure the safety and effectiveness of injectors used in medical applications. It outlines requirements for the device's performance, quality, and usability to minimize 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.

EN 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 to ensure their safety and effectiveness.

In conclusion, EN ISO 11608-1: 2016 is an essential standard for the design, development, and use of medical devices for drug delivery. It provides for manufacturers, developers, and healthcare professionals to ensure that injectors are safe, reliable, and effective in delivering medications to patients.