本文件规定了医疗应用中输送液体的储液罐连接器的一般要求。这些储液罐连接器用于与患者一起使用的医疗设备或附件中。 本文件还规定了这些储液罐连接器拟用于的医疗保健领域。 这些医疗保健应用领域包括但不限于 -呼吸的， -肠内， -神经的， -血管内， -柠檬酸盐抗凝剂溶液，以及 -灌溉。 本文件中规定的储液罐连接器不可与以下部件互连: -ISO 18250系列中规定的所有其他应用的储液罐连接器； -ISO 80601-2-74:2017附录EE中规定的可拆卸温度传感器端口； -ISO 17256[1]附录B中规定的螺纹接头； 除非ISO 18250系列中另有规定。 ISO 18250系列的应用部件可以指定附加的连接器，使用这些连接器（如这些应用部件中所规定）可以不使用储液罐连接器- 可互联。 本文件提供了基于其固有设计和尺寸评估储液罐连接器不可互连特性的方法，以降低医疗设备之间或不同应用的附件之间错误连接的风险。 本文件未规定使用这些储液罐连接器的医疗设备或附件的要求。这些要求在特定医疗设备或附件的特定国际标准中给出。 注1:鼓励制造商将ISO 18250系列中规定的储液罐连接器纳入医疗设备、医疗系统或附件中，即使相关特定医疗设备标准目前没有要求。预计在修订相关特定医疗器械标准时，该系列标准中规定的储液罐连接器要求将包括在内。 注2:ISO 18250系列不适用于螺钉和皇冠软木瓶盖和颈部，因为它们不是医疗设备专用的连接器。 DIN 55525、ASTM D2911/D2911M、DIN 6063-1、DIN 6063-2、DIN 168-1中定义了螺帽和颈管的示例。DIN 6094、ISO 12821、EN 14635中定义了皇冠软木瓶盖和瓶口的示例。 本文件还规定了验证储液罐连接器通用性能要求的试验方法。这些常用试验方法的性能要求在应用部分而非一般部分中规定。 [1] 正在准备中。出版时的阶段:ISO/DIS 17256:2017。

This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for — respiratory, — enteral, — neural, — intravascular, — citrate-based anticoagulant solution, and — irrigation. Reservoir connectors as specified in this document are non-interconnectable with: — the reservoir connectors of every other application specified in the ISO 18250 series; — removable temperature sensor port specified in Annex EE of ISO 80601-2-74:2017; — the nipples specified in Annex B of ISO 17256[1]; unless otherwise specified in the ISO 18250 series. Application parts of the ISO 18250 series can specify additional connectors with which reservoir connectors (as specified in those application parts) are to be non-interconnectable. This document provides the methodology to assess non-interconnectable characteristics of reservoir connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. This document does not specify requirements for the medical devices or accessories that use these reservoir connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the reservoir connectors specified in the ISO 18250 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for reservoir connectors as specified in the series of standards will be included. NOTE 2 The ISO 18250 series does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. Examples of screw caps and necks are defined in DIN 55525, ASTM D2911/D2911M, DIN 6063-1, DIN 6063-2, DIN 168-1. Examples of crown cork caps and necks are defined in DIN 6094, ISO 12821, EN 14635. This document also specifies the test methods to verify the common performance requirements for reservoir connectors. The performance requirements for these common test methods are specified in the application parts and not in the general part. [1] Under preparation. Stage at the time of publication: ISO/DIS 17256:2017.