Nightingale M J, Lees B, Biset R, Mertens W
National Blood Service, Southampton, UK.
Vox Sang. 2006 Oct;91(3):264-9. doi: 10.1111/j.1423-0410.2006.00832.x.
ISO standards for blood bags do not adequately define and control the dimensions of blood bag transfer tubing. This lack of standardization presents potential difficulties when making sterile connections between the wide range of tubing that has evolved in the absence of such standards. We aim to validate the suitability of the TSCD-II and provide a minimum standard for assessing the suitability of sterile connections (welds) between dissimilar tubing.
The Terumo TSCD-II was used in this study to connect by hermetic welding seven tubing types with a wide range of dimensions from five suppliers. Thirty sterile connections were made between each combination split between dry/dry, wet/wet and dry/wet connections. Welds were assessed for visual defects, by tensile stress test (TST) and pressure tests.
All welds passed visual inspection and pressure tests. All welds had a minimum tensile strength of greater than 40 N and mean of greater than 45 N.
Successful connections have been made between dissimilar tube types and this work does not support the requirement for 'tight' tubing dimensional specifications. We have recommended to the ISO Technical Committee 76 Work Group 1 that ISO 3826-1 be revised and should include a minimum standard validation protocol for joining dissimilar tubing.
血袋的国际标准化组织（ISO）标准未充分界定和控制血袋转移 tubing 的尺寸。在缺乏此类标准的情况下，大量 tubing 不断发展，这种标准化的缺失在进行无菌连接时带来了潜在困难。我们旨在验证 TSCD-II 的适用性，并为评估不同 tubing 之间无菌连接（焊接）的适用性提供最低标准。
本研究使用泰尔茂 TSCD-II 通过气密焊接连接来自五个供应商的七种尺寸范围广泛的 tubing 类型。在每种组合的干/干、湿/湿和干/湿连接之间进行了 30 次无菌连接。通过拉伸应力试验（TST）和压力试验评估焊接的外观缺陷。
所有焊接均通过外观检查和压力试验。所有焊接的最小拉伸强度均大于 40 N，平均值大于 45 N。
已成功实现不同类型 tubing 之间的连接，且这项工作不支持对“紧密”tubing 尺寸规格的要求。我们已建议 ISO 技术委员会 76 工作组 1 修订 ISO 3826-1，并应包括用于连接不同 tubing 的最低标准验证方案。
