BS EN ISO 1135-4:2015规定了医疗用一次性输液重力装置的要求 以确保其与血液和血液成分容器以及 静脉注射设备。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 并确保集合与一系列细胞和血浆血液成分的相容性。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 594-2:1998EN ISO 3696:1995ISO 3696:1987EN ISO 3826-1:2013ISO 3826-1:2013EN ISO 3826-2:2008ISO 3826-2:2008EN ISO 7864:1995ISO 7864:1993EN 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 11135ISO 11137ISO 17665-1IEC 80416-1EN 15986ISO 7000购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with 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 a range of cellular and plasma blood components.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 594-2:1998EN ISO 3696:1995ISO 3696:1987EN ISO 3826-1:2013ISO 3826-1:2013EN ISO 3826-2:2008ISO 3826-2:2008EN ISO 7864:1995ISO 7864:1993EN 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 11135ISO 11137ISO 17665-1IEC 80416-1EN 15986ISO 7000All current amendments available at time of purchase are included with the purchase of this document.