标准编号:ISO 1135-5:2015

中文名称:医用输血器具 第5部分:带压力输液装置用一次性输血器  

英文名称:Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus

发布日期:2015-12

标准范围

This part of ISO 1135 specifies requirements for single use transfusion sets for use with pressure infusionequipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensurescompatibility with containers for blood and blood components as well as intravenous equipment.Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the qualityand performance of materials used in transfusion sets, to present designations for transfusion setcomponents, and to ensure the compatibility of sets with red cell and plasma blood components.Platelet components should not be transfused under pressure using these sets.In some countries, the national pharmacopoeia or other national regulations are legally binding andtake precedence over this part of ISO 1135.

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