ISO 11608 Series Overview
The ISO 11608 series of standards serves as a comprehensive set of guidelines and requirements for needle-based injection systems used in the administration of medicinal products, specifically those intended for parenteral (injectable) use. These standards are designed to ensure the safety, reliability, and quality of these devices throughout their lifecycle, from design and development to manufacturing, testing, and use.
The primary purpose of the ISO 11608 series is to promote patient safety by providing a framework for the design and manufacturing of these devices, as well as establishing criteria for their performance and functionality. By adhering to these standards, manufacturers can ensure that their devices meet the necessary requirements for proper administration of medicinal products, reducing the risk of errors, contamination, or other adverse events.
Smithers Medical Device Testing Division has extensive experience in assisting device manufacturers with demonstrating compliance against the requirements from the ISO 11608 series of standards. The applicability of the requirements is dependent on the type of device being produced. The standards within the ISO 11608 series are applicable to handheld and on-body devices including Autoinjectors , Pen injectors, Pre-filled syringes with safety systems, and On-body delivery systems.
