标准编号：ISO 3826-4:2015
中文名称：人体血液和血液成分用可折叠塑料容器 第4部分：集成功能脱落血包系统
英文名称：Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
发布日期：2015-08
标准范围
This part of ISO 3826 specifies requirements including performance requirements for aphaeresisblood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of theintegrated 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.This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varyingquantities of blood components or cells by apheresis. This part of ISO 3826 can be used on automated orsemi-automated blood collection systems.In some countries, the national pharmacopoeia or other national regulations are legally binding andtake precedence over this part of ISO 3826.
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