ISO 80369-1:2018 卫生保健应用中液体和气体用小口径连接器 第1部分：一般要求

标准编号：ISO 80369-1:2018

中文名称：卫生保健应用中液体和气体用小口径连接器 第1部分：一般要求

英文名称：Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

发布日期：2018-11

标准范围

ISO 80369-1:20 18本文件规定了在医疗保健应用中输送液体或气体的小口径连接器的一般要求。这些小孔连接器用于旨在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小口径连接器预期使用的医疗保健领域。这些医疗保健领域包括但不限于:-呼吸系统和驱动气体；-肠内；-肢体袖带充气；-神经轴；-血管内或皮下注射。本文件提供了基于其固有设计和尺寸评估小口径连接器不可互连特性的方法，以降低本文件中规定的医疗器械之间或附件之间以及ISO 80369系列未来部分下开发的不同应用的错误连接风险。本文件未规定使用这些小口径连接器的医疗器械或附件的要求。这些要求在特定医疗器械或附件的国际标准中特别给出。注1第7条允许对ISO 80369系列中包含的新应用进行小口径连接器的附加设计。注2鼓励制造商将ISO 80369系列中规定的小口径连接器纳入医疗器械、医疗系统或附件中，即使相关特定医疗器械标准目前没有要求。预计在修订相关特定医疗器械标准时，将考虑变更为ISO 80369系列标准中规定的新小口径连接器的相关风险。注3:ISO 80369系列中规定的连接器仅用于其规定的应用。将这些连接器用于其他应用会增加发生危险错误连接的风险。注4鼓励制造商和负责组织向ISO/TC 210秘书处报告他们使用ISO 80369系列中规定的小口径连接器的经验，以便在修订ISO 80369系列的相关部分时考虑该反馈。

ISO 80369-1:2018 This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields include, but are not limited to:
- breathing systems and driving gases;
- enteral;
- limb cuff inflation;
- neuraxial;
- intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of small-bore 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 as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 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, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

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