Guidance Document on EN ISO 15223-1 new symbols for Sterile Barrier Systems (SBS)

New “Guidance Document on EN ISO 15223-1 new symbols for SBS” is now published in our Document Library . This revision of the guidance document includes learnings from applying the symbols and represents the consensus of the members of the SBA.

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 EN 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 EUMDR 2017/745 and to provide additional user benefits.

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Fill out the form below to enquire about becoming a member 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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Company Main Products / Services

We would love to keep you updated on our latest news and updates

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