BS EN 868-9:2018

What is BS EN 868-9 – Packaging for terminally sterilized medical devices about?  

BS EN 868-9 is the ninth part of the BS EN 868 multi-series that discusses packaging for terminally sterilized medical devices. This European standard helps its users to verify the quality of packaging products intended for medical devices.  

BS EN 868-9 specifies test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. 

Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, BS EN 868-9 specifies materials, test methods, and values specific to the products covered by it. 

The materials specified in BS EN 868-9 are intended for single use only. 

Who is BS EN 868-9 – Packaging for terminally sterilized medical devices for? 

BS EN 868-9 on requirements and test methods for packaging products intended for medical devices is useful for: 

• Manufacturers of medical devices 
• Packaging companies that cater to the medical industry 

Why should you use BS EN 868-9 – Packaging for terminally sterilized medical devices?  

The development and construction of packaging systems for terminally sterilized medical devices is complicated and critical to patient safety. 

BS EN 868‑9 improves on the quality standards set by EN ISO 11607‑1 and EN ISO 11607‑2 by providing you with test methods and requirements for specific products. The test methods described in BS EN 868‑9 help you to verify whether these medical devices meet those necessary requirements.  

These guidelines of BS EN 868‑9 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises. 

What’s changed since the last update? 

BS EN 868-9:2018 supersedes EN 868-9:2009. The main changes in BS EN 868-9:2018 as compared to EN 868-9:2009 are as follows: 

• Changes in order to align this document with the EN ISO 11607 series, in particular by: 
• Elucidating the requirements given by EN ISO 11607‑1 as general requirements for this standard 
• Formulating the significance and limits of the requirements of this document with respect to the requirements given by EN ISO 11607‑1 
• A new general requirement has been introduced concerning the difference in design and use for polyethylene based and polypropylene based polyolefin materials 
• The clause for performance requirements and test methods has been divided subsequent into general and specific requirements 
• The specific requirements under section performance requirements and test methods distinguish between polyethylene based materials and polypropylene based materials 
• For polypropylene based materials 2 new requirements have been introduced; these contain different values compared to unchanged requirements/values for polyethylene based materials