What is ISO/TR 11166:2016 ?

What is ISO/TR 11166:2016?

ISO/TR 11166:2016 is a technical standard that provides guidelines for the design and testing of autoinjectors for medical use. It is a widely recognized standard that aims to ensure the safety, reliability, and quality of autoinjectors.

The primary aim of ISO/TR 11166:2016 is to establish a set of requirements for autoinjectors that ensure consistent performance and user-friendliness. These requirements encompass various aspects, such as device compatibility with different medications, accurate dosage delivery, ease of use, reliability, and safety. By adhering to this standard, manufacturers can develop autoinjectors that meet these essential criteria.

Key Requirements of EN ISO 11166:2016

ISO/TR 11166:2016 is a professional technical standard that provides guidelines and requirements for the design, development, and use of medical devices for drug delivery. It focuses specifically on the design and functionality of injectors.

The purpose of ISO/TR 11166:2016 is to ensure the safety and effectiveness of injectors used in medical applications. It sets out requirements relating to the performance, quality, and usability of these devices to minimize risks associated with drug delivery.

ISO/TR 11166:2016 covers a wide range of injectable devices, including pen injectors, auto-injectors, and needle-based injection systems. It also addresses aspects such as device labeling and user instructions, as well as compatibility with different drug formulations.

By following the guidelines and requirements set out in ISO/TR 11166:2016, manufacturers can develop autoinjectors that are safe, reliable, and effective for use in medical applications. This ensures that patients receive the appropriate dose of medication and minimize the risk of adverse reactions.

In conclusion, ISO/TR 11166:2016 is an essential standard for the design and testing of autoinjectors for medical use. By adhering to the key requirements of this standard, manufacturers can develop autoinjectors that meet the essential criteria for safety, reliability, and quality, ultimately ensuring the safety and effectiveness of the devices.