Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
塑料用于人血液和血液成分的可折叠容器 - 第4部分:具有集成特征的Aphaeresis血液袋系统
发布日期:
2015-07-24
ISO 3826-4:2015规定了具有集成功能的无气采血袋系统的要求,包括性能要求。Aphaeresis血袋系统不需要包含ISO 3826本部分中确定的所有集成功能。
集成功能包括:针棒保护装置、白细胞过滤器、无菌屏障过滤器、采集前取样装置、红细胞储存袋、血浆储存袋、血小板储存袋、多形核细胞(例如干细胞)储存袋、采集后取样装置,以及储存溶液、抗凝剂和更换液的连接。
ISO 3826-4:2015规定了用于通过单采采集不同数量血液成分或细胞的血袋系统的附加要求。
它可以用于自动或半自动血液采集系统。
ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826.
The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid.
ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.