BS EN 868-6:2017

What is BS EN 868-6 - Packaging for terminally sterilized medical devices about?  

BS EN 868-6 is the sixth part of the EN 868 multi-series that discusses packaging for terminally sterilized medical devices. 

BS EN 868-6 specifies test methods and values for paper used in the manufacture of preformed 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 868-6 specifies materials, test methods, and values specific to the products covered by it. 

Paper specified in BS EN 868-6 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for trays. 

The materials specified in BS EN 868-6 are intended for single use only. 

Who is BS EN 868-6 - Packaging for terminally sterilized medical devices for? 

BS EN 868-6 on requirements and test methods for paper for low temperature sterilization process is useful for: 

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

Why should you use BS EN 868-6 - 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. These packaging systems need to meet certain requirements to be suitable for packaging medical devices. 

BS EN 868‑6 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 paper for low temperature sterilization process. The test methods described in BS EN 868‑6 help you to verify whether the paper meets those necessary requirements. 

These guidelines of BS EN 868‑6 enable you to maintain sterility of the medical devices and maintain hygiene in hospital premises. 

What’s changed since the last update? 

BS EN 868-6:2017 supersedes BS EN 868-6:2009. BS EN 868-6:2017 includes some technical changes with respect to BS EN 868-6:2009. These include: 

• The test method on fluorescence is in accordance with ISO 2470-2. The test method according to Annex B has been deleted 

Changes in order to align this European Standard 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 standard with respect to the requirements given by EN ISO 11607-1 
• Linking the test methods with regard to information on statement of precision and bias, repeatability and reproducibility to EN ISO 11607-1:2009+A1:2014, Table B.1 

Updating of the following test methods by a statement of repeatability and reproducibility: 

• Method for the determination of water repellency as per Annex B 
• Method for the determination of pore size as per Annex C