ISO 11040-4:2024 - Latest Updates and Requirements

With the release of the fourth edition of ISO 11040-4:2024, it officially rescinds and replaces the third edition, ISO 11040-4:2015. This updated version introduces several significant changes and enhancements to the standard, incorporating the latest industry practices and providing improved clarity throughout. The main changes to the standard include:

Update to general requirements for quality systems, testing and documentation: 
Documentation and activities within the standard must now adhere to a formal Quality Management System (QMS). Test equipment must be qualified, and test methods validated. All documentation should be retained according to the QMS, and both electronic records and handwritten signatures related to validation, process control, or other quality decision-making processes shall be documented.

Specific requirements for staked needle syringes added: 
Needle diameter and length as well as the design of the finger flange will be agreed between the manufacturer and the client. A table has been added for tolerances on the various combinations of syringes volume and needle length. Additionally, figures illustrating typical staked needle syringe designs have been included.

Specifications for finger flange breakage resistance, front end breakage resistance and penetration force added: Flange breakage resistance and front end breakage resistance (previously Luer cone breakage resistance) now have specified minimum force to break values. A specification has now been provided for the maximum force for a needle top penetrate a test foil, this is to help detect needle point and lubrication defects that have an impact on patient comfort.