BS EN 868-10:2018

What is BS EN 868‑10 - Packaging for terminally sterilized medical devices about?  

BS EN 868‑10 is the tenth part of the BS EN 868 multi-series that discusses packaging for terminally sterilized medical devices. BS EN 868‑10 specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868‑9 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 868‑10 specifies materials, test methods, and values specific to the products covered by it. The materials specified in BS EN 868‑10 are intended for single use only. 

Who is BS EN 868‑10 - Packaging for terminally sterilized medical devices for? 

BS EN 868‑10 on the requirements and test methods for packaging for terminally sterilized medical devices is useful for: 

• Manufacturers of single-use medical devices 
• Manufacturers of packaging materials and packaging systems for sterile devices 
• Healthcare facilities with in-house or contracted sterilization services 

Why should you use BS EN 868‑10 - 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 868‑10 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 like medical gloves, hair caps, and surgeon masks. The test methods described in BS EN 868‑10 help you to verify whether these medical devices meet those necessary requirements.  

These guidelines of BS EN 868‑10 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises. 

What’s changed since the last update? 

BS EN 868‑10:2018 supersedes EN 868‑10:2009. Changes between BS EN 868‑10:2018 and EN 868‑10:2009 are the following: 

• Normative references have been updated 
• References to ASTM standards have been added 
• The test method for determination of seal strength and mode of specimen failure according to Annex C has been amended 
• Bibliography has been updated 

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