BS ISO 11040-6:2019

What is BS ISO 11040-6 about? 

BS ISO 11040-6 addresses plastic barrels for injectables and syringes that are ready for filling. BS ISO 11040-6 specifies materials, dimensions, quality, and performance requirements for these barrels and syringes. BS ISO 11040-6 discusses test methods for these polymer barrels and sterilized sub-assembled syringes ready for filling, intended for single use only. 

BS ISO 11040-6 helps you with designs requirements, dimensions, and material requirements for these barrels and syringes. BS ISO 11040-6 is useful for technical committees that are responsible for medical device standards.  

Who is BS ISO 11040-6 for? 

BS ISO 11040-6 on prefilled syringes is applicable for: 

• Syringe manufactures  
• Medical device engineers and designers 
• Quality control personnel 

Why should you use BS ISO 11040-6? 

Syringes carry the inherent risk of drug contamination. This can endanger health. Prefilled syringes eliminate that risk. BS ISO 11040-6 helps you to design, manufacture, and test syringe barrels.  

By using BS ISO 11040-6 guidelines, you increase the durability of these syringe barrels, and ensure safety for people’s health as well as the environment. 

What’s changed since the last update? 

BS ISO 11040-6:2019 supersedes ISO 11040-6:2012. BS ISO 11040-6:2019 includes some technical changes with respect to ISO 11040-6:2012 which are:  

• General requirements have been added for the quality system, testing, and documentation 
• Requirements for labelling and syringe barrels have been revised 
• Requirements for the packaging have been added