This document provides guidance for both supply and demand parties to reach agreement on the technical requirements for materials and manufacturing, physical properties, performance requirements, size, appearance, printing, packaging labeling, etc. of the sterile barrier system in the form of product specifications. The requirements covered in this document apply to suppliers of sterile barrier systems and to device manufacturers using sterile barrier systems. This guide can be used as a reference for both parties to formulate quality agreements or technical requirements. This document is suitable for herringbone three-side seal bags, head bags and corner peel-off three-side seal bags. Other bag making forms can also be implemented by reference after consensus between the supply and demand parties.
T/CAMDI 057-2020 history
2020T/CAMDI 057-2020 Standard Guide for Writing a Specification for Sterilizable Peel Pouches