How Surgical Centers Ensure Compliance with Sterilization Pouches

Sterilmedipac24 Jul, 2025Business

Sterilization pouches are regulated barrier systems. In the US they are Class II medical devices requiring FDA clearance and validation. Manufacturers must follow ISO 11607 (sterile barrier systems), ISO 11140 (indicator performance), and AAMI standards (e.g. AAMI ST79).