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Standards Development
This document details suitable equipment and a test method to help ensure compatibility between a transfusion set closure piercing device (referred to in this document by the abbreviation 'spike') and a blood bag outlet port is within advisable limits by measuring the insertion force.
The connection between a blood bag (as specified in ISO 3826 parts 1, 3 and 4) and transfusion set (ISO1135 parts 4 and 5) is provided by the blood bag port and transfusion set closure piercing device (spike). The spike is a rigid structure with tightly defined dimensions whereas the blood bag port is of flexible material in order to accommodate the spike. Transfusion sets need to be compatible with a range of commercially available blood bags and vice versa. It is vitally important in setting up a blood transfusion that the force required to insert the spike into the port is not excessive which can lead to difficulties in piercing the port septum, damage to the blood bag, leakage of its contents and injuries to bedside staff.
This Technical Specification details suitable equipment, a test method and acceptance criteria to ensure that the insertion force is within acceptable limits. The test procedure in its entirety is complex and beyond the scope of each of the mentioned standards. This Technical Specification was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets.
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