P376.20
Plastic collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
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| Technical Committee | Technical Committee, CD6 – Plastic Products – Medical Device Working Group |
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“This part of ISO 3826 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 part of ISO 3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO 3826 does not cover automated blood collection systems. Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastic container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO 3826-1, where applicable.”
