SBA MD –

About

SBA (Sterile Barrier Association) is a global organization focused on the science and technology of sterile barrier systems used in the healthcare industry. They provide resources and education related to packaging, sterilization, and sterility assurance.

While not a national regulatory body, SBA supports adherence to international standards related to sterilization and packaging, such as ISO 11607 and ISO 11135. Their work is relevant to companies subject to FDA 21 CFR Part 820 (Quality System Regulation) and EU MDR/IVDR requirements.