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Standards Development
This document specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document.
The integrated features refer to:
— leucocyte filter;
— pre-donation sampling device;
— top-and-bottom bag;
— platelet storage bag;
— needle stick protection device.
In addition to ISO 3826-1, which specifies the requirements of conventional containers, this document specifies additional requirements for blood bag systems using multiple units. This document does not cover automated blood collection systems.
Unless otherwise specified, all tests specified in this document apply to the plastic container as prepared ready for use.
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