SBA issues Guidance Document for new EN ISO 15223-1 Symbols - 22 August 2019

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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 risk mitigation, new legal requirements deriving from the EU-MDR 2017/745 and user benefit.

 

To read the full report, click here.