Transfusion equipment for medical use-Transfusion sets for single use with pressure infusion apparatus
医用输液设备
发布日期:
2016-01-31
BS EN ISO 1135-5:2015规定了压力输液用一次性输液器的要求
能够产生高达200千帕(2巴)压力的设备。本国际标准确保
与血液和血液成分容器以及静脉注射设备的兼容性。ISO 1135本部分的次要目的是提供与质量相关的规范指南
以及输液器所用材料的性能,以显示输液器的名称
成分,并确保集合与红细胞和血浆成分的相容性。血小板成分不应使用这些装置在压力下输注。在一些国家,国家药典或其他国家法规具有法律约束力,且
优先于ISO 1135的本部分。交叉引用:ISO 594-1:1986ISO 594-2:1998ISO 3696:1987EN ISO 3696:1995ISO 3826-1:2013EN ISO 3826-1:2013ISO 3826-2:2008EN ISO 3826-2:2008EN ISO 10993-
1:2009ISO 10993-1:2009EN ISO 10993-4:2009ISO 10993-4:2002ISO 10993-4:2002/A1:2006EN ISO 14644-1:1999ISO 14644-1:1999EN ISO 15223-1:2012ISO 15223-1:201293/42/EECISO 291ISO 7000ISO 11135ISO 11137ISO 17665-1IEC 80416-1EN 15986ISO 7864购买本文件时提供的所有现行修订件均包含在购买本文件中。
BS EN ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion
equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures
compatibility 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 quality
and performance of materials used in transfusion sets, to present designations for transfusion set
components, 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 and
take precedence over this part of ISO 1135.Cross References:ISO 594-1:1986ISO 594-2:1998ISO 3696:1987EN ISO 3696:1995ISO 3826-1:2013EN ISO 3826-1:2013ISO 3826-2:2008EN ISO 3826-2:2008EN ISO 10993-1:2009ISO 10993-1:2009EN ISO 10993-4:2009ISO 10993-4:2002ISO 10993-4:2002/A1:2006EN ISO 14644-1:1999ISO 14644-1:1999EN ISO 15223-1:2012ISO 15223-1:201293/42/EECISO 291ISO 7000ISO 11135ISO 11137ISO 17665-1IEC 80416-1EN 15986ISO 7864All current amendments available at time of purchase are included with the purchase of this document.