The Sterile Barrier Association (SBA) created and validated new symbols for Sterile Barrier System (SBS) configurations respective packaging systems for sterile medical devices for inclusion into ISO 15223-1. Reasons for inclusion of such symbols are to control specific risks with aseptic presentation, to comply with new legal requirements deriving from the EU-MDR 2017/745 and to provide additional user benefits.

To provide additional assistance for users during the implementation of these new requirements, the SBA has launched some example images to show how the symbols may be configured.

The first image shows the outer box being used as Protective Packaging (PP). In many situations an outer box, will not be designated as Protective Packaging (PP) and so will not require the symbol labelling, however this image was created purely as an example to show how the symbol would be configured if an Outer PP was necessary.

The second image, which is one of the most common configurations, indicates a double Sterile Barrier System (SBS). This shows the outer pouch, which is an SBS in its own right and so is labelled with a double SBS symbol, containing a second pouch, which is again a SBS  and so is labelled as a single SBS.

 

    Fill out the form below to enquire about becoming a new member company or affiliate to the SBA.

    Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Affiliation is open to companies/trade associations/healthcare professionals who are Responsible Users of SBS or represent those that are. Potential members or affiliates also need to have implemented a quality management system certified by an accredited certification body.

    For more details see Why become a member?

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