医疗器械.医疗保健用储液罐输送系统用连接器.第1部分:一般要求和通用试验方法

[中文适用范围]： 本文件规定了医疗应用中的储液器连接器的一般要求。这些储液器连接器用于与患者一起使用的医疗设备或配件。本文件还指定了这些储液器连接器预期使用的医疗领域。这些医疗领域的用途包括但不限于：——呼吸，——肠内，——神经，——血管内，——基于枸橼酸的抗凝溶液，以及 ——冲洗。根据本文件规定的储液器连接器与以下内容不互连：——ISO 18250系列中指定的其他应用的储液器连接器；——ISO 80601-2-74:2017附录EE中指定的可移除温度传感器端口；——ISO 172561)附录B中指定的奶嘴，除非另有规定在ISO 18250系列中。ISO 18250系列的应用部分可以指定其他互不连接的连接器，这些连接器将与根据那些应用部分指定的储液器连接器不互连。本文件提供了评估储液器连接器的非互连特性特征的方法，以降低医疗设备或不同应用之间的辅助装置之间的错误连接风险。本文件不对使用这些储液器连接器的医疗设备或配件提出要求。特定国际标准为特定医疗设备或配件规定了此类要求。注1：鼓励制造商将ISO 18250系列中指定的储液器连接器纳入医疗设备、医疗系统或配件中，即使当前的相关特定医疗器械标准没有要求。预期当相关特定医疗器械标准修订时，将包含对本系列标准中规定的储液器连接器的要求。 [外文原描述]： 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.